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Chapter News New: Chapter Development Highlights (PDF) Note: Chapters that do not have news provide their contact information. Chapters are listed alphabetically, by state/country.
Arizona (Phoenix) Valley of the Sun SoCRA Chapter NewsThe Phoenix SoCRA Chapter is a quarterly forum for anyone interested or working in clinical research. The meeting is held in March, June, September and December of each year in the Phoenix metropolitan area. One continuing education credit (CEC) is available for attending the one-hour, clinical research-related presentation given by an invited speaker (attendance is free!). Past meeting summaries and selected presentations will be available at subsequent meetings. MEETING ANNOUNCEMENT Wednesday Location: Speaker: Speaker Title: Speaker Affiliation: Presentation: Summary: Light refreshments will be provided at the end of the tour. Please bring a friend and spread the word! CEC Available: 1 Credit Questions: Planning to Attend? Please RSVP: jjones@medicis.com California (Los Angeles) SoCRA Chapter NewsDate: Wednesday, August 13, 2008 Time: 6:00 PM – 7:30 PM Topic: Monitoring and Auditing to Ensure Protocol Compliance and GCP Presenter: Location: 1 CE credit hour is available for SoCRA Certified Professionals Directions: www.cityofhope.org/About/dir_campus.htm Campus Map: www.cityofhope.org/About/campusmap.htm California (Northern CA) SoCRA Chapter NewsWe are pleased to announce the September meeting of the Northern California Chapter of SoCRA, the Society of Clinical Research Associates. Topic: The Essentials of Good Clinical Practices Speaker: Daniel Redline, BA, CCRP, CCRC Date and Time: Thursday January 21, 2010 from 12:00-1:00PM Place: UC Davis Medical Center, Clinical & Translational Science Center (CTSC), 2921 Stockton Blvd., Sacramento, CA. For directions to the, please visit: www.ucdmc.ucdavis.edu/ctsc/directions/ Cost: FREE admission (All members and nonmembers welcome) For more Information: Please contact the following individuals: Daniel Redline (Chair) Denise Owensby (Vice Chair) Rayanne Hildreth (Education & Outreach Officer) *SoCRA members are credited with 1 hour of Continuing Education (CME or CNE). Please share this meeting announcement with your colleagues. California (Orange County) SoCRA Chapter NewsDate: Thursday, December 17, 2009 Time: 5:30-6:30 PM Topic: Industry-Sponsored Studies Contracts and Budgets Speaker: Location: Maps for UC Irvine and the surrounding area can be located at: www.uci.edu/campusmaps.html or http://today.uci.edu/pdf/UCI_07_map_campus.pdf FREE Admission (All members and nonmembers are welcome) More information: Please contact Chapter Chair Maribelle Sunga, BSMT, CCRP at (323) 271-1330, cell (323) 353-2941 or mgsmedresearch@aol.com. CE: SoCRA members are credited with 1.5 SoCRA Continuing Education Unit. “Please bring or submit your recruitment issues for group discussion as part of a post-presentation meeting.” California (San Diego) SoCRA Chapter NewsMeeting Announcement Date: February 24, 2010 Wednesday Time: 6:00 - 7:00 PM Place: Speaker: Dr. Linda Strause, Ph.D. Executive Director, Oncology Clinical Operations, Vical, Inc. Topic: Current Issues in Patient Recruitment A 2006, The Center for Information & Study on Clinical Research Participation (CISCRP) survey conducted among 900 US adults found that the public’s perception regarding why people choose to participate in clinical trials is because they are ‘very sick without any other options’ or they are ‘looking to make money’. Sadly, also in this study, 34% of Americans said that they ‘Do Not Admire’ people who volunteer for clinical trials. (www.cicsrp.org) Dr. Strause is a board member of CISCRP and will discuss with our SoCRA Chapter the current issues in patient recruitment and address concerns about ethics in recruiting. Is recruitment of subjects difficult for your clinical trial? It may be part of a larger concern. CE: One hour CEU credit is offered for attending this session. RSVP: California (San Francisco Bay Area) SoCRA Chapter NewsWe are pleased to announce the November meeting of the San Francisco Bay Area Chapter of SoCRA, the Society of Clinical Research Associates. Topic: “Keys to a Personalized Informed Consent Processt”
Speaker: Peggy Devine, Founder & President, Cancer Information & Support Network, Inc. Date and Time: Thursday, January 21, 2010; 2:00 – 4:00 PM Place: UCSF/Mt. Zion campus, Lurie Conference Room, 2340 Sutter Street, 1st floor, San Francisco, CA 94115. Please stop and sign in with front desk guard. For directions, please visit www.ucsf.edu/maps/mtzion.html Cost: FREE admission (All members and nonmembers welcome) For more Information: * SoCRA members are credited with 1.5 SoCRA Continuing Education Unit (CEU). California (South Bay - LA to San Diego Area) SoCRA Chapter NewsFrom San Diego to Los Angeles…..covering Southern California, the last piece of the puzzle! YOU ARE INVITED TO THE FIRST MEETING OF: THE SOUTH BAY CHAPTER OF SOCRA! When: 10-10-2007 @ 4:00 PM Where: Breastlink Offices/701 E. 28th St./Suite #414/Long Beach, CA 90806 Contact: Mary Suarez @ 562-933-7866 or msuarez@memorialcare.org Wondered about SoCRA? Who are they? Where are they? What do they do? Would it benefit me to join? Do they have fabulous desserts at the Long Beach meetings? (YES!). Members and non-members are welcome. The topic of discussion will be Recruitment with guest speakers: Joetta Wallace MSN, RN, FNPC Alicia Martin-Santiago/Research Inquiry Coordinator Tarek Dessouky, M.D.,DIS, MBA, MPH Looking forward to meeting you all! California (Ventura County) SoCRA Chapter NewsThe California SoCRA Chapter of Ventura County would like to invite you to our exciting 2009 Spring Program which will be hosted by Amgen Inc. of Thousand Oaks on Monday, March 23, 2009. The guest speaker, Natalie Currie, will present and generate discussion on "The Globalization of Clinical Research." Speaker: Natalie’s breadth of roles has spanned from Clinical Research Coordinator, Clinical Research Associate, Clinical Research Project Manager and management roles in Government and Health Economics. She has worked at the Addiction Research Foundation (now the Centre for Addiction and Mental Health [CAMH]), Janssen-Ortho Inc. (a division of Johnson and Johnson) and has participated on international project teams for pivotal Phase III studies and led Canadian Phase IIIb-IV studies. Natalie holds an honors life science degree from the University of Toronto and is a member of the Society of Clinical Research Associates, as well as the Canadian and American Societies of Training and Development. Natalie designs and facilitates engaging, customized corporate and public workshops in the areas of clinical research study management, train-the-trainer and presentation mastery. Presentation: Admission: Date and Time: Location: Parking is available in the main parking lot which is located at the intersection of Amgen Center Drive and Pauling Drive. Agenda: One Continuing Education (CE) credit will be given to SoCRA members for attending this meeting. Please share this announcement with your colleagues. Colorado SoCRA Chapter NewsDear Colleagues, The Colorado Chapter is pleased to announce a Supplemental Education Meeting held in conjunction with the Clinical Investigations Core of the University of Colorado. This meeting will be held at the Anschutz Campus. Date: March 17, 2010 Time: 12:00-1:00 PM Agenda: Cord Blood Transplant Speaker: Location: University of Colorado Denver, Anschutz Campus, Rocky Mountain Lions Eye Institute (RMLEI), room 3008 Directions and parking information: The campus is located at 1665 Aurora Court, Aurora, CO For additional information please contact Rachel Wood, Rachel.wood@ucdenver.edu Area map and Fitzsimons campus map Area Map
Fitzsimons Campus Map
Connecticut SoCRA Chapter NewsSociety of Clinical Research Associates (SoCRA) Connecticut Chapter Meeting Wednesday, October 1, 2008
Connecticut Children’s Medical Center Featured Speaker and Topic: Improving the Informed Consent Process: A Guide for Investigators in Developing Materials and Presenting Information to Parents and Children Jointly sponsored by: Connecticut Children’s Medical Center, Hartford Hospital and the Society of Clinical Research Associates Please RSVP to Bertha Robbins, RNC, CCRP at brobbin@ccmckids.org by September 26th. Members and non-members are welcome. *1 Continuing Education Credit hour for SoCRA CCRP Renewal will be awarded. Please share this announcement with your colleagues. Crossroads SoCRA Chapter News - Indiana/Ohio/Kentucky/IllinoisThe Crossroads Chapter of SoCRA presents: The Prevention and Resolution of Compliance Issues – a CRA Perspective Presented by: Tuesday, January 20, 2009
Attendance is free and open to SoCRA and non-SoCRA members. Indiana University Cancer Pavilion (RT) 101 Parking is available for a fee in both the parking garages south of Michigan Street on Barnhill Drive. This program has been awarded 1.0 Continuing Education Unit (CEU). If you plan to attend and would like a CEU certificate, please contact Cynthia Partridge-Bunin at cynthia.partridgebunin@gmail.com. Florida (Central) SoCRA Chapter NewsThe Central Florida Chapter Winnie Palmer Hospital for Women & Babies Valet parking available at $5.00 DATE: July 29, 2009 9:00 – 9:30 Registration, Welcome & Updates 9:30 – 10:30 Mildred Beam, Esq. 10:30 – 10:45 Break 10:45 – 12:15 Panel 1 - Budgets, Billing & Contracts 12:15 – 1:30 Lunch (Winnie Palmer has a wonderful cafeteria with a wide selection of entrées) 1:30 – 3:00 Panel 2: How research is managed among diverse settings There is no fee for this program 4 SoCRA continuing education credit hours have been approved**SoCRA accepts documentation of candidate participation in continuing education programs for re-certification for programs applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. Please RSVP by email to Lorraine Hickson, CCRP at Lorraine.hickson@orlandohealth.com Please share this announcement with your colleagues. Florida (South) SoCRA Chapter NewsInvitation to Healthcare Professions Interested in Clinical Research We are pleased to announce the first educational seminar hosted by the South Florida Chapter of The Society of Clinical Research Associates (SoCRA): Date: Wednesday, March 23, 2005 Time: 12:00 -1:00 p.m. Location: Topic: Research Methods In Clinical Trials: From The Bench To The Bedside Guest Lecturer: Aurea M. Flores, Ph.D., University of Miami Refreshments will be served. One-hour of Continuing Education Credit is available. Seating is limited. Please RSVP by March 18, 2005 Contact: Telephone: 305-243-6823 E-mail: fcoleman@med.miami.edu ***There is no cost involved to attend this lecture. Georgia SoCRA Chapter NewsDate: May 16, 2009 Time: 10:00 - Noon Place: Topic: Increasing Minority Participation in Clinical Trials (The restaurant will collect a $10 cover charge from all attendees and brunch will be served.) Presenter: Dr. Nicole Forman Speakers Bio: Please share meeting date and time with your colleagues. Sarah Wilson, MS, CCRP Lisa Larry-White Sharon Hyland Great Lakes SoCRA Chapter News - Michigan/Ohio/WisconsinChapter Chairperson: Halifax, Nova Scotia, Canada SoCRA Chapter NewsThe Halifax Chapter of SoCRA presents: A MONITOR’S PERSPECTIVE: “SOURCE DOCUMENTATION” December 8, 2008 - 1200 to 1315 PM Halifax Infirmary QEII Health Sciences Centre 1200 NOON – Chapter Update 1215 – 1315 – Presentation Start Guest Speaker: Please rsvp to: Sue.Moore@cdha.nshealth.ca (902) 473-4128 Halifax Infirmary: Illinois - Chicago Area SoCRA Chapter NewsDear Colleague: The CHICAGO AREA SOCRA CHAPTER Presents a SEMINAR: Speaker: Date: Wednesday, May 19, 2004 Time: 1:15 - 4:30 PM Location: Local Chapter Business meeting will follow the
presentation. Nominations are being taken for the Local Chapter Chairperson. Please submit your Name (SoCRA members), Title, Institution, SOCRA background and research experience by May 7, 2004 to Rosemarie Schubert at e-mail address below. Volunteers are also needed to serve on the Education Committee. A candidate roster will be generated and forwarded via e-mail by May 14, 2004. Elections for the Local Chapter Chairperson will be held at the May 19, 2004 Business Meeting. Please RSVP to: Or for any other questions: Cafeteria nearby for refreshments. 1 CE credit hour is available for SoCRA Certified Professionals Please join us in this seminar on these very important topics and become acquainted with your research colleagues in the Chicago area SoCRA Chapter. Kingston, Ontario Canada SoCRA Chapter NewsWhen: Thursday September 27, 2007 Where: KGH Shea Conference Rm., Burr 1, Rm: 21-1061 Time: 6:30 PM to 7:30 PM Guest Speaker: Please RSVP: SoCRA CE credit: 1.0 Maine SoCRA Chapter NewsThe State of Maine SoCRA Chapter will have a meeting on January 24, 2008 at 2PM. The presentation will be “Adverse Event Reporting using the CTCAE Version 3.0”. The meeting will be held at Acadia Clinical Research, 304 Hancock St, Bangor, ME, Suite # 2J Members planning to attend should RSVP: Maryland SoCRA Chapter NewsThis Chapter targets all clinical research professionals. We strive to be in-depth and educational and to offer opportunities for greater understanding of the full clinical research process -- from the nascent steps in the laboratory to the operations of sponsors, CROs, NIH, sites, the business office, and finally onto market approval and post-market studies. Date: March 22, 2010 Cost: No Cost Presentation: 5:45 p.m. – 7:45 p.m. (two hours of CE) Facilitator: Anne N. Martien, MBA, CCRP, CRCP, MD SOCRA Chapter Chairperson Topic: We will be watching a DVD called “FACE-OFF”. It is a mock subject injury trail based on the facts of a real case and recorded at a MAGI conference. Alan Milstein and Fred Rom, world famous attorneys who were the actual plaintiff and defense lawyers, argue this mock clinical trial subject injury case on the DVD. There will be a discussion period afterward. Location: Parking: SoCRA CEU Credit: 2.0 hours of CE is available for SoCRA members. RSVP: Anne N. Martien, MBA, CCRP Limit: Registrar Request: Please share this announcement with your colleagues. Massachusetts SoCRA Chapter NewsMEETING ANNOUNCEMENT DATE: TIME: LOCATION: SPEAKER: Amanda Hammond, JD, Deputy Director, Office of Human Research Studies, Dana-Farber Cancer Institute TOPIC: Data and Safety Monitoring Plans and Boards: NCI Requirements and IRB Responsibilities OVERVIEW:
CREDITS: Participants may claim up to one hour of SoCRA CEU. (members may only claim actual time spent in the educational event.) Certificates of attendance will be available at the completion of the event. QUESTIONS: Please contact, Alyssa K. DellaCroce, MPH CCRP 617-632-3731or adellacroce@partners.org Michigan - Saginaw Bay Chapter NewsThe Saginaw Bay Chapter of SoCRA is holding a meeting in conjunction with the IOMSN meeting is Saginaw on April 25th, 1PM to 2PM. Featured Speaker Topic: Featured Topic: Location: Contact information and R.S.V.P. Minnesota Southeast (SEMN) SoCRA Chapter News (MN/WI/IA)SEMN SoCRA Chapter meetings for February Thursday, March 4
Title: “Informed Consents: It’s Elementary” Objectives:
1 CEU offered Location: Geffen Auditorium, Subway level of the Gonda Building, Mayo Campus downtown Parking is available at City and Mayo ramps No RSVP required Inquiries can be directed to Teresa Zais at zais.teresa@mayo.edu Midwest Regional SoCRA Chapter News (Missouri)Colleen Kilbourne-Glynn Mubai, India (Maharashtra) SoCRA Chapter News - All IndiaAll India Chapter, SoCRA The first meeting of the SoCRA All India Chapter will be held: Sunday 21st December 2008 Location: Speakers: 1. Dr. Dilip Pawar. MD. - Chief Operating Officer, Akela Pharma, Mumbai, India. Presentation Title: Future of Clinical Trial Monitoring Summary: Clinical Trial monitoring is of utmost importance in clinical research. Monitoring involves interaction of investigators with sponsors’ team. Improper monitoring might cause build of lot of quires and can prolong the timelines of clinical trial subsequently leading to increasing cost. This presentation will focus on monitoring importance in coming era of e-technology. 2. Dr. Shirish Sherlekar MD. - Head Life Science Practice. Tata Consultancy Services, Mumbai, India. Presentation Title: Clinical Research Outsourcing trends: Current and Future Summary: India is one of the top destinations for outsourcing clinical research. India currently offers advantages in the area of English speaking western trained medical and para medical professionals, software skills, treatment naïve patients, economic clinical trials. Will these points support India as a destination for clinical research in next decade? Contact: Dr. Vaidehi Limaye. Email: socraindia@yahoo.com This program will offer 2.0 SoCRA Continuing Education Units. SoCRA Chapter meetings are free to SoCRA members and nonmembers. Please share this announcement with your colleagues. All India SoCRA Chapter is a forum for anyone interested or working in clinical research. We conduct regular interactions and meetings through this chapter. Iowa/Nebraska/South Dakota (Central Plains) SoCRA Chapter NewsThe SoCRA Central Plains Area Chapter Title: Adverse Events, Serious Adverse Events, and Unanticipated Problems--What really needs to be reported to the IRB? Guest Speaker: When: Where: Sanford USD Medical Center, Sioux Falls, SD Videoconference site: UNMC See directions below for both facilities. Objectives:
Teleconferencing may be available upon request. RSVP – 3 days in advance. Please email Chapter Chairperson if interested. In an effort to be “Green,” program materials will be provided electronically upon request (before or after presentation). Please email amykeyes@creighton.edu. Members and non-members welcome. This activity has been planned and implemented in accordance with the Society of Clinical Research Associates. This educational activity received no commercial support. SoCRA has approved this program for 1 continuing education contact hour for members. Directions to University of Nebraska Medical Center, Sorrell Center for Health Sciences:
Directions to Sanford USD Medical Center: 1305 W 18th Street, Sioux Falls, SD 57104 Meeting Room C:
New Mexico SoCRA Chapter NewsDate: Wednesday, January 13, 2010 Time: 6-7:00 PM Location: Guest Lecturer: Topic: Things your Statistics Professor Didn’t Tell You: How to Apply Statistics to Research Join the speaker for a brown bag dinner @ 5:30 PM One hour of SoCRA Continuing Education Credit is available. Directions: Approaching from the west of the Gibson campus or from I-25: Exit on Gibson Blvd East. Travel approximately 2½ miles past San Mateo. Drive to the east side of the Gibson campus to the light at Valencia. Turn right into the Gibson parking lot. The Education Building is located at the corner of Gibson and Valencia. Enter the building. The West Classroom is left of the auditorium. Approaching from the east of the Gibson campus: From the intersection of San Pedro and Gibson travel west approximately 2 blocks to the light at Valencia. Turn left into the Gibson parking lot. The Education Building is located at the corner of Gibson and Valencia. Enter the building. The West Classroom is located to the left of the auditorium. Contact: New York Hudson Valley SoCRA Chapter NewsNew York Hudson Valley SOCRA Chapter - Southern NY/New Jersey Meeting Date: December 10, 2009 7:00 – 8:00 PM Presentations with 1 CE 5:30 – 6:45 PM Optional Networking/Dinner (see details below) We are pleased to announce our end-of-the-year chapter meeting. The New York Hudson Valley SoCRA chapter targets all clinical research professionals in the Southern region of New York (Manhattan, the Bronx, Queens, Brooklyn and Staten Island) including Westchester, Rockland, Orange, Putnam, Dutchess and Ulster Counties and our neighboring state, New Jersey. Cost: Free admission to the Presentation (open to SoCRA members and non-members) Presentation: 7:00 p.m. – 8:00 p.m. – Chapter offers one hour of CE for SoCRA members. Attendance will be recorded and a Certificate of Attendance will be provided Location: Please ask for the “SoCRA Clinical Research/Clinical Trials Meeting” when you arrive to be directed appropriately. Speakers and Topics: 1. The topic of her research presentation is as follows: 2. The topic of her presentation is as follows: “Optional” Networking and Dinner: 5:30 p.m. – 6:45 p.m. (must call or e-mail by December 5th to confirm attendance at dinner: 845-458-4545 or choward-century@slchospital.org) Seating is limited to only10 people for 1 reserved table. If attending dinner: After dinner, we will all walk a short distance from the waterfront, under the railroad trestle, to the presentation at the Library. “Xaviers X20 on the Hudson”(located behind the Metro North Yonkers Train Station “Hudson Line Train,” which is right on the waterfront by the “New York Water Taxi”) Restaurant Address: 71 Water Grant Street, Yonkers, NY 10701 Reservation under the name “Century” table of 10 Note: Dinner is optional. Food or beverages at the attendee’s expense The menu at X20 incorporates classic French technique with Italian and Spanish influences, and Asian embellishments which create a wholly original cuisine unique to the Hudson Valley. X2O’s Main Dining Salon's 25 foot vaulted ceiling and 3 walls of glass frame offers views of the George Washington and Tappan Zee Bridges, as well as sunsets over the Palisades. Please go to the restaurant’s website for directions and menus. Directions: By Train: Metro-North Train “Hudson Line” (to Yonkers, New York) Frequent trains from Grand Central Terminal to Yonkers (4:54 PM train arrives in Yonkers at 5:25 PM. Train leaves from NYC at 5:20 PM, 5:22 PM and runs about every 15 to 30 minutes). Train from Poughkeepsie leaves at 3:40 and must transfer to arrive in Yonkers at 5:31 PM. For more information on train schedules and fares, contact: 212-532-4900 or www.mta.info Amtrak also stops at the Yonkers station. Contact: 800-872-7245 By Bus: Express Bus (Bee-Line) from Manhattan. Other buses to Yonkers contact: Westchester County Bus 914-813-7777 By Car: for travel directions see the X2O website www.xaviars.com/yonkers/directions.html or the Yonkers Riverfront Public Library website: www.ypl.org/riverfront Parking: There is parking on the street (must pay by meter) around the restaurant and the library. A Parking Garage is located near the station. RSVP: Limit: 20 participants (room capacity) so please RSVP by December 5th New York State SoCRA Chapter NewsNew York State SoCRA Chapter Education Program Announcement Saturday, May 9, 2009 “FDA Inspection – Uncovering the Mystery” “Notes to File - An Auditor’s Perspective” "Perceived Change in Nursing Practice Post Implementation of an Electronic Medical Record in a National Comprehensive Cancer Network." Catering Fee: $25.00 Suggested Hotel: Return this form and check payable to caterer “DoubleTree” by April 30, 2009 to: ~ SoCRA continuing education= 6.0 credit hours ~ North Carolina (East) SoCRA Chapter NewsGreetings, The March 2010, meeting of the Clinical Research Professionals of North Carolina (a chapter of SoCRA also referred to as NC East or the RTP chapter) will be held on Monday, 1 March, 2010 at Durham Technical Community College (DTCC), Durham, from 6:00 to 7:00 PM. The meeting will be held in the Multi-Purpose Room of the Phail Wynn Jr. Student Services Center. This month's meeting will feature Ms. Olga Deyneka, Clinical Research Associate, Health Decisions. She will be speaking on "Adverse Event Reporting to IRBs - Improving Human Subject Protection" OUR TOPIC: Adverse Event Reporting to IRBs - Improving Human Subject Protection SPEAKER: Olga Deyneka, Clinical Research Associate II, Health Decisions, Inc. SUMMARY: Upon completion of this presentation the participants will:
ABOUT OUR SPEAKER: CREDIT HOURS: This program offers 1.0 SoCRA CEUs QUESTIONS:
DIRECTIONS TO DURHAM TECHNICAL COMMUNITY COLLEGE From I 40 (Take 40W from airport or 40E from Chapel Hill)
From here, there are 2 locations to park: Location 1: Across the street from the Wynn Center building (the tall, brick building). This is the main campus parking. Go to the cross walk and cross Lawson Street. Follow the sidewalk to the Wynn Center. The Multipurpose Room is inside on your left. Location 2: Pass “DTCC main campus” on right
*If coming from Durham towards RTP, take the first Briggs Avenue exit and turn RIGHT. Stay in that right merge lane and turn right onto Lawson. The remaining directions are the same. A campus map and additional directions are available at www.durhamtech.edu/html/aboutdt/campusmap.htm North Carolina (Winston-Salem/Northwest) SoCRA Chapter NewsThe Northwest North Carolina SoCRA Chapter is pleased to announce its first meeting of 2008. Date: January 24, 2008 Time: 12 Noon – 1 PM (bring a bag lunch; vending available) Location: 2nd floor classroom, OTP Building Topic: Legally Effective Informed Consent: What it Means and How to Obtain It Speaker: Cheryl Byers, MHA, CIP About the Speaker: Ms. Byers is the director of the Wake Forest University School of Medicine IRB. Prior to her current position, she worked with WFUSM in research as a project manager and clinical research manager. Her expertise is in the interpretation of the federal regulations as they pertain to the safety, rights and welfare of human subjects who participate in research. Ms. Byers has been with the Institutional Review Board since December 2003. Prior to her work at WFUSM, Ms. Byers worked for managed care, specifically two health maintenance organizations in North Carolina as a health education specialist and provider relations specialist. Ms. Byers holds a Bachelor of Science degree in Health Education at East Carolina University and a Master of Health Administration from the University of North Carolina at Charlotte. She is also a certified IRB professional and a member of PRIM&R. She has presented nationally for the Association on Clinical Research Professionals (ACRP), the Society of Clinical Trials (SCT) and SoCRA on topics ranging from academic clinical research, clinical research basics, informed consent, and the use of electronic systems for increased compliance. She has also presented in many additional forums on the impact of the HIPAA Privacy Rule on human subject research. Directions: Wake Forest University Baptist Medical Center is located in Winston-Salem, NC. WFUBMC employees can take the shuttle to the OTP building via the PTCRC shuttle which runs every half-hour from the Main Tower. If you have a group, you can request a pickup by calling 6-RIDE (6-7433) from an internal phone. All others should contact Angela Kimel at akimel@wfubmc.edu or 336-716-6522 for directions as the OTP building is separate from the main campus. Once inside the building, take the elevator or stairs to the second floor. At the door on the right (left, if taking the stairs), you may scan a WFUBMC badge or ring the bell to gain entrance. Once inside, the classroom is the last door on the left. Credits: Participants may claim up to one hour of SoCRA CEUs (members may only claim actual time spent in the educational event). Certificates of attendance will be available. North Central Regional SoCRA Chapter NewsNorth Central Regional SoCRA Chapter presents: Title: "Where the FDA Regulations End and ICH Begins - The Differences and Similarities between the Two in GCP" This presentation will review the similarities and differences between the FDA regulations and the ICH GCPs and is targeted to investigator sites and the sponsor personnel (CRAs and Study Managers) that work with them. Learning Objectives:
Speaker: Paul Below, Clinical Research Consultant Time and Date: From 4:00 P.M -5:00 P.M on Wednesday April 09, 2008 Location: SoCRA Continuing Education Credit: 1 hour All are welcome (SoCRA members and non-members) and this presentation is free of charge to all. Please RSVP to: Ohio "Northeast" SoCRA Chapter NewsDate: Wednesday November 4, 2009 Time:
Location: Guest Speaker:
Topic: Clinical Trials – The Patient Perspective Kaye has been involved in three clinical trials. She will share her personal experiences in being in different types of research trials and why she chose to be a research participant. Biography of Speaker: Kaye Spector writes about the people employed by Cleveland's health and medical institutions and the communities they create. She also writes the Healthy Cleveland/Vital Signs column. Kaye came to The Plain Dealer in 2000 and has covered local news, disabilities issues, and suburban life. She most recently was an assistant metro editor. SoCRA CEUs: 1.0 All are welcome (SoCRA & non-SoCRA Members) to attend our Northeast Ohio Local Chapter Meeting. This will be a great opportunity to network with other research professionals. Dinner will be provided. PLEASE RSVP TO DRIVING DIRECTIONS: DRIVING DIRECTIONS: Please note that the Euclid area is still under construction and may require additional driving time. From the East via Interstate 90, exit at Martin Luther King Jr. Boulevard. Proceed south for about a mile to the East 105th traffic light; cross East 105th and bear right through the traffic circle, continuing along Martin Luther King Jr. Boulevard to Euclid Avenue. Turn left onto Euclid and watch for the Information Booth at the right. From the East via Interstate 80 (Ohio Turnpike - From Eastern Ohio and Pennsylvania), Take the Ohio Turnpike to the interchange for I-480 West (Exit 187.) Proceed west on I-480, which merges with I-271 North. Stay north on I-271 then exit at Cedar Road (sharp right turn off exit ramp). Follow Cedar Road westbound toward Cleveland. (Case is about 20-25 minutes from this point.) Where Cedar starts down a steep hill, look for a sign identifying Case Western Reserve University on your right at the corner of Murray Hill Road. Continue down Cedar Road under the bridge and veer to the right at the next light on Martin Luther King Jr. Blvd. Turn right onto Euclid and watch for the Information Booth at the right. From the West via the Ohio Turnpike (Interstate 80), exit at Exit 142 and follow Interstate 90 east. Shortly after passing the downtown exits, exit at Martin Luther King Jr. Boulevard. Proceed south for about a mile to the East 105th traffic light; cross East 105th and bear right through the traffic circle, continuing along Martin Luther King Jr. Boulevard to Euclid Avenue. Turn left onto Euclid and watch for the Information Booth at the right. From the South via Interstate 71 or Interstate 77, proceed north until I-71 (or I-77) merges with Interstate 90. Take I-90 east then exit at Martin Luther King Jr. Boulevard. Proceed south for about a mile to the East 105th traffic light; cross East 105th and bear right through the traffic circle, continuing along Martin Luther King Jr. Boulevard to Euclid Avenue. Turn left onto Euclid and watch for the Information Booth at the right. Alternate route through downtown Cleveland: Any of the above directions can be altered if desired by taking route 90 into downtown Cleveland and exiting on Chester Avenue. Head east on Chester to Euclid (just past E. 105th st). Turn left onto Euclid and look to the right for the information booth. For further information on directions, please go to: www.case.edu/visit/map/b25.html Parking The parking area on Cornell is the closest parking with the most availability. The rate for parking is approximately $8 - $10. Alternative parking locations would be the Rainbow Garage or Veale Garage on Adelbert Road. For further information on parking locations, please go to: www.case.edu/visit/map/index.html. Ohio Valley SoCRA Chapter NewsDear Colleague: We are pleased to announce the first meeting of the Ohio Valley Chapter of SoCRA, The Society of Clinical Research Associates. Topic: What to expect in an FDA audit Sub-Topics:
Date: Oct 6, 2004 (Wednesday) Time: 6-7:30 PM Place: Cincinnati Children's Hospital Medical Center Sabin Auditorium Speaker: Hugh McClure, FDA Investigator/Bioresearch Monitoring Specialist Cost: FREE admission Refreshments provided Please RSVP to Tiffany Losekamp, Chapter Chairperson at 513-759-5128 or Tiffany.Losekamp@cchmc.org Oklahoma SoCRA Chapter NewsDear Colleague, You are invited to our next Oklahoma SoCRA Chapter meeting: When: Wednesday, June 14th - 11:30 AM -1:00 PM Where: OUHSC Bird Library – Provost Conference Room #223 Topic: “An Access Data Base Experience” Presented by: Elaine Reeves, CCRP, Clinical Research Coordinator, Pediatric Hematology Oncology RSVP to : Christina-Gonzalez@ouhsc.edu Come see what can be shared about utilizing an Access Data Base for managing patients and IRB info. Elaine has been using her system in various forms for 20+ years and is willing to share some tips with us. Please come and join us and bring those who might be interested. We will be having a “Chef Salad” pot luck lunch (see list below). If you do not wish to participate in the potluck then feel free to bring your own lunch. What we have:
What we need:
Please RSVP’s to Christina Gonzalez at (405) 271-4412 ext. 42551 or email Christina-gonzalez@ouhsc.edu to let us know what you will be bringing or if you are bringing your own lunch. Space limited to 40. Directions are available for those of you not on campus. 1 hr. Continuing Education Credit available SOCRA is the Society of Clinical Research Associates. Our local chapter is committed to providing education on campus and statewide to those involved in clinical research. Our meetings are held on the 2nd Wednesday of every month. Please feel free to come even if you are not a member of SOCRA. You can find further information about the national SOCRA organization and certification testing at www.socra.org Oregon SoCRA Chapter News“Successful Implementation of Clinical Trials” Admission: Date and Time: Conference call and Webex information available upon request. Location: Free parking is available at the 8500 and 8300 Creekside Place. Both of these buildings are occupied by Welch Allyn. CEUs Offered: 6 hours RSVP: Please RSVP no later than August 14th to Angie Rock (angela.rock@welchallyn.com).
8:30 AM – 9:00 AM – Registration 9:00 AM – 9:15 AM - Welcome & What is a SoCRA member? 9:15 AM – 10:00 AM - Recruitment 10:00 AM – 10:15 AM - Break 10:15 AM – 11:15 AM - Data Management 11:15 AM – 12:15 PM - Basic Statistics 12:15 PM – 1:30 PM - Lunch Break (Network with a bag lunch or enjoy various local eateries in walking or driving distance.) 1:30 PM – 2:15 PM - Research Financial Management & Budgeting, What I AM Learning 2:15 PM – 2:30 PM - Break 2:30 PM – 3:15 PM - Device Basics 3:15 PM – 3:30 PM Closing Comments Ottawa, Ontario Canada SoCRA Chapter NewsWednesday, January 20, 2010 Location: The Ottawa Hospital - Riverside Campus in the Amphitheatre, Lower Level (LL) Topic: “Conducting Clinical Trials in Tough Economic Times” The topic will be the Kidney Research Centre’s poster presentation at the annual SoCRA conference held in Nashville Sept. 25th to 27th, , 2009. This poster presentation will demonstrate how The Kidney Research Centre (KRC) maintained an innovative group of research professionals during an enormous growth spurt in today’s tough economic times. We will detail the obstacles encountered as well as the resolutions developed when moving from an all Registered Nurse (RN) staff to a diverse staff that includes, well educated, non-nursing coordinators, student interns and university students. Presneted by: Room directions: In the main building take the “service” elevator to the SD level, then turn right. Go to the end of the hall, turn left. It is the 1st room on the left. Parking: On site parking available – hourly rate 1 Continuing Education Credit Hour may be claimed for attendance at this presentation. Certificates of attendance will be available at the completion of the event. Contact Information: Co-Chairs of the SoCRA Ottawa Chapter: Brenda Bradley, RN CCRP Or Judy Cheesman, RN, C NephC, CCRP Pennsylvania / Delaware Valley SoCRA Chapter NewsThe revitalized Pennsylvania/Delaware Valley SoCRA Chapter is pleased to announce its Februray chapter meeting. All are welcome to attend our education program, no membership required: “Monitoring & Preparations for Sponsor Audits for Study Sites” DATE: Wednesday, February 17th, 2010 TIME: 4:30-5:30 PM LOCATION: Note: the Lankenau Hospital Auditorium is located at the Main Entrance of the hospital, taking the stairs or elevator to the ground floor. Stairs are located to the right of the information desk in the main lobby. TOPIC: “Monitoring & Preparations for Sponsor Audits for Study Sites” FEATURE PRESENTER: OBJECTIVES:
ABOUT OUR SPEAKERS: CREDIT HOURS: SoCRA members may claim up to 1.0 SoCRA CEUs for SoCRA recertification. ATTENDANCE: Program is FREE and is open to SoCRA & Non-SoCRA members. We thank IT&E International for their support of this program, including light refreshments during the meeting. QUESTIONS: Chapter Chair Maria Hendricks, MSN, RN, CCRP: hendricksma@mlhs.org SAVE THE DATE: 2010 UPCOMING MEETING SCHEDULE:
DIRECTIONS: Lankenau Hospital is located just outside the western city limits of Philadelphia in Wynnewood, Pennsylvania (Lower Merion Township; Montgomery County). Once in Philadelphia, you can get to Lankenau by car, taxi, train, or bus. Driving Directions:
Public Transportation To map your trip or to find out about possible delays, visit the SEPTA site. From Center City Philadelphia BY SUBWAY AND BUS, take the Market-Frankford Elevated line to the 69th Street terminal, and transfer to the 105 bus to Lankenau. The SEPTA G bus, which serves major portions of the city, also stops at Lankenau. PARKING: 2 Options: Conference Parking is available free of charge (space permitting). Note: this is located at the rear of the hospital, next to the Employee Parking Lot. It will require walking a reasonable distance to the Annenberg Conference Building that is located to the left of the Front entrance of the Hospital. To locate Conference parking area, follow the Conference Parking signs and proceed to the back (past parking lot B and the Employee Parking Lot) to the Roof top area indicated as Conference Parking. Lot A and Lot B Parking: **Charges apply**. Note: Lots A & B parking areas are the closest to the conference center. Parking Lot A, flanks the Annenberg Conference Building. Charges are the responsibility of the attendee. Tennessee, Greater Nashville Regional SoCRA Chapter NewsStates: Middle Tennessee/Greater Nashville, Western Kentucky Thursday, February 25, 12-1PM Room 415 Light Hall Featured Topic: Ms. Wujcik will provide learners with the basic tools needed for developing abstracts and posters. Key questions for consideration are: How do I select a topic? What are the parts of an abstract and/or poster? What are the steps involved in developing the abstract/poster? Speaker: Sponsorship: Jointly sponsored by Vanderbilt School of Medicine; Department of Medicine, Division of Rheumatology and the Society of Clinical Research Associates. Accreditation and Credit Designation: This activity has been planned and implemented with the Essentials Areas and Policies of the Accreditation Council for CME (ACCME) through the joint sponsorship of Vanderbilt School of Medicine and the Society of Clinical Research Associates. Vanderbilt School of Medicine is accredited by the Accreditation Council for CME to provide continuing medical education for physicians. Vanderbilt School of Medicine designates this educational activity for a maximum of 1 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity. Disclosure Statement: All course directors, planners, and speakers indicated no financial relationships to disclose. Commercial Support: This educational activity received no commercial support. Members and non-members welcome. Please bring your lunch. SoCRA has approved this program for 1 continuing education contact hour for members. Tennessee, Mid-South SoCRA Chapter NewsWhen: June 10, 2009, 1:30 – 2:30 PM “Key Elements of Research Compliance” 3.0 CEU SoCRA hours Location: St. Jude Children’s Research Hospital (SJCRH), Auditorium (Patient Care Center)
Everyone welcomed and there is no fee to attend! Contact Information: Nancy West: nancy.west@stjude.org or 901.595.6018 Yvette Montague: yavette.montague@stjude.org or 901.595.6018 Driving Direction to SJCRH, Memphis, TN: Traveling West:
Traveling East :
Traveling North:
Traveling South:
Texas, Greater Houston/Galveston SoCRA Chapter NewsTuesday, March 9th, 10:00AM-12:00PM Room 069E (near Luby's) on the main Baylor campus (One Baylor Plaza, Houston, TX 77030) Featured Speaker and Topic: "Informed Consent Workshop" Presented by: The Research Compliance Services, Office of Research Sponsorship: Jointly sponsored by Research Compliance Services of Baylor College of Medicine and the Society of Clinical Research Associates. Disclosure Statement: All course directors, planners, and speakers indicated no financial relationships to disclose. Commercial Support: This educational activity received no commercial support. Members and non-members welcome. Seating is limited so please RSVP to researchcomplianceservices@bcm.edu SoCRA has approved this program for 2 continuing education contact hour for members. Texas, Greater San Antonio SoCRA Chapter NewsSoCRA San Antonio Chapter Meeting CANCELLED Date: December 2, 2009 Time: 5:30PM-7PM
Speaker: Title of the program: Location of Meeting: Synergyst Research is located on the corner of I-10 and Huebner in the Chase Building. Free visitor parking is located at the front of the building. Program is FREE and is open to SoCRA & Non-SoCRA members! SoCRA CEU Credit: 1.0 hour CE is available for SoCRA members. Certificates of attendance will be provided. Please RSVP by November 27, 2009! For more information and to RSVP please contact the San Antonio Chapter Chair: Texas, West SoCRA Chapter NewsFebruary 9 , 2010 12:00-1:00 PM CST TOPIC: Clinical Research Associates and Their Patients: A Multi-Faceted Relationship SPEAKER: SUMMARY: OBJECTIVES:
LOCATIONS:
For further information: Terry Fountain, CCRP Please RSVP by January 18, 2010: terry.fountain@umchealthsystem.com No food will be provided but attendees may bring their own lunch. *1 Continuing Education Credit hours for SoCRA CCRP Renewal will be awarded. Meetings are open to members and non-members. Please share this announcement with your colleagues. Tokyo, Japan SoCRA Chapter NewsJAPAN CHAPTER SEMINAR ANNOUNCEMENT Japan SoCRA Chapter and NPO CORE are pleased to announce the educational seminar for CRPs on Saturday, March 20, 2010 in Tokyo. Donna Headlee, RN, BSN, CCRP from the United States and past president of SoCRA will be our speaker. Donna will discuss concepts related to developing and adapting SOPs for an effective SOP program. She will use examples from her experiences to illustrate concepts. Date: Saturday, March 20, 2010 Time: 18:00 - 19:00 (after the CCRP Exam) Location: Kitasato University, School of Pharmaceutical Sciences Directions/map: www.pharm.kitasato-u.ac.jp/location-e.html Target: Clinical Research Professionals Program: 17:30 - 18:00 Registration 18:00 - 19:00 Lecture and Discussion Language: Japanese only CCRP credit: 3.0 CE Participation fee: free Japanese information: www.crsu.org/SoCRA_Japan/ Advanced registration: Please email to SoCRAJapan_Committee@umin.ac.jp including your name, affiliation, by March 12, 2010. This program is co-hosted by Japan SoCRA Chapter (www.crsu.org/SoCRA_Japan/) and Please see the announcement in Japanese. Toronto, Canada SoCRA Chapter News (Greater Toronto)"Ethical Issues in End Of Life Research" Speaker: Date: Thursday, Feb 25, 2010 Time: 6:00PM-7:30PM Location: Please bring your refreshments RSVP: susanna.sellmann@uhnresearch.on.ca biljana.gillmeister@sickkids.ca If you plan to attend videoconference at CREDIT VALLEY HOSPITAL Contact: Tabassum Tahir: TZahir@cvh.on.ca SoCRA CE credit: 1 hour GTA SoCRA Chapter contact: Susanna Sellmann Please share this announcement with your colleagues. Utah/Idaho SoCRA Chapter NewsWe are pleased to announce the first meeting of the SoCRA Utah / Idaho Chapter. Please join us for this opportunity for continuing education and professional development. The Huntsman Cancer Institute and University of Utah IRB has invited the SoCRA Utah / Idaho Chapter to participate in a webinar offered by FDANews The meeting will be held: March 17, 2010 from 8:30 – 10:30 AM Huntsman Cancer Institute Auditorium Speaker: Charles H. Pierce, MD, PhD, FCP, CPI Topic: “Adverse Event Reporting Compliance – The Key to Safe Drug Development.” A Continuing Education certificate of attendance will be issued to each participant by FDANews. SoCRA will recognize this program’s attendance certificate for 2 hours of CE credit for SoCRA CCRP (Certified Clinical Research Professional) re-certification requirements. A Chapter organizational meeting will follow the Webinar to discuss participation/future meetings/venues. R.S.V.P to: Gina Gregovich via email: gina.gregovich@hci.utah.edu Vancouver, Canada SoCRA Chapter NewsVancouver SoCRA Chapter is pleased to announce the 4th Vancouver Island Clinical Research Education Symposium: Date: Friday, November 27, 2009 Time: 0830-1430 Location: Registration: Presentation Topics and Speakers 8:30-9:00 Registration 9:15-10:00 Health Canada’s Clinical Trial Inspection Program 10:00-10:15 Health Break 10:15-11:00 Devil is in the Details - Using Technology in Collaborating for Best Practices 11:00-11:45 Globalized Clinical Research Environment Driven By Cost, Speed and Quality 12:00-1:00 Lunch 13:00-14:30 Optimizing Monitor & Research Coordinator Interactions: Presentation and Audience Participation **To facilitate discussions, please email Anika Patel (anika.patel@viha.ca) any questions you may have for the speakers by November 18, 2009 Full day attendees will receive 3.75 CE hours toward SoCRA re-certification Morning presentations will accrue 2.25 CE hours toward SoCRA re-certification Afternoon presentations will accrue 1.50 CE hours toward SoCRA re-certification Vermont SoCRA Chapter NewsDate: Wednesday, March 31, 2010 Time: 12:00-1:00 EST Title of Program: Speaker Name: Ellen Travis, FNP, MSN Location: 1.0 SoCRA continuing education credit hours approved* *SoCRA accepts documentation of candidate participation in continuing education programs for re-certification for programs applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. Directions: From I-89 North or South
Program Objectives : Participants will lean the principles guiding registration of clinical studies through National Institutes of Health (NIH) Clinicaltrials.gov. The following information will be reviewed:
For more information contact the Vermont Chapter Chair: Washington SoCRA Chapter NewsWashington State Chapter meeting Date: Thursday, November 5, 2009 Time: 5:00 PM - 9:00 PM Program: University of Washington Tumor Vaccine Group Open House Refreshments and hors d'oeuvres will be provided/sponsored by selected area restaurants 5:00 PM - 6:30 PM
5:30 PM Lab Tours 6:30 PM Presentations: Bench to Bedside: Controlling Cancer With the Immune System
7:30 PM Panel Discussion on Trial Participation 8:00 PM Lab Tours 9:00 PM Wrap Up Speakers Include:
CEU: SoCRA members may claim up to 2.5 hours of CEUs for SoCRA recertification. Location: Free Parking On-Site SoCRA members and non-members welcome, please invite your colleagues! This event is open to the public. RSVP: Merle Witter, CCRP Washington D.C. "National Capital Area" SoCRA Chapter News
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