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FAQ's

What is HIPAA?

Click Here for an article (PDF) on the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, which focuses on its impact on research and researchers.

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Clinical Trial Terminology - Glossary and Acronyms

Click Here for Clinical Trial Terminology - Glossary and Acronyms!

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How can I get into clinical research?

  • Join SoCRA - this will allow you to begin networking and understand the roles in clinical research.  You will receive four SoCRA Source magazines per year and the opportunity to attend our annual conference, which has educational sessions at a reduced rate.
  • Attend our educational programs beginning with the Clinical Science Course which is a five day workshop aimed at those new to the field and those wanting a refresher.   See Educational Workshops for more information.
  • Certification is recommended.  If eligible (see Certification for more information), the member will have the opportunity to sit for the certification exam.  For those not eligible, the opportunity will still be there when they meet eligibility requirements.  A study guide is available and this is a good reference tool to have even if not taking the exam.  The cost is $50.00 if purchased separately, and it is included in the cost of registration to take the examination.
  • Subscribe to Applied Clinical Trials (web site www.actmagazine.com) and perhaps Research Nurse (web site www.researchnurse.com). Both journals are excellent in the way of educating the clinical research professional and introducing the reader to the many career opportunities.
  • Internet: Do your homework... browse and read about clinical research companies, associations, latest technologies and other like organizations to keep up with what is going on in the field.
  • Lastly, talk to others in the field and ask them what they do and how. Become familiar with all the different aspects of clinical research and position yourself to be "in the know."

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Are there any clinical research courses?

Yes, many clinical research courses with non-profit organizations like SoCRA, ACRP, DIA, SCDM, and SCT offer courses in the form of one to two day workshops for specific topics and a combination of topics.  SoCRA offers a 5-day course.  Other courses are available through commercial training companies like Center Watch and The Center for Clinical Research Practice.

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How do I get answers for FDA regulations questions?

Click here for a listing of FDA small business representatives in your area.

www.fda.gov/ora/fed_state/Small_business/sb_guide/smbusrep.html

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Are there any schools with specifically designed curriculums in clinical research offered by institutions of higher learning?

Structured curriculums are available at colleges and universities throughout the U.S.

Information about programs of which we are aware follows. This is by no means a complete listing - but just a starting point from which you may begin your search for educational opportunities in the field of Clinical Research.

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Boston University

Boston University in Boston, Massachusetts offers a Master of Arts in Clinical Investigation (MACI) at the Boston University School of Medicine.

www.bu.edu/maci/index.html

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British Columbia Institute of Technology

BCIT (British Columbia Inst. of Tech) distance learning program.
Contact: Mary Sue Fairbarn, MKPE, CCRC
(604) 432-8329
mfairbar@bcit.ca
www.health.bcit.ca/CRP

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Campbell University

Campbell University, North Carolina offers a masters program through their school of pharmacy (two year evening program).

Contact: Manny Diliberto, Director
(910) 893-1690

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Drexel University

Master of Science in Clinical Research
Master of Science in Research Management and Development
Master of Science in Clinical Research Management and Development

Drexel eLearning Tuition Discount for Spouses of SoCRA Members

As a member of SoCRA, you are eligible to receive a 10-25% reduction off the regular on-campus tuition rate at Drexel University when you take courses online. As an added benefit, spouses of SoCRA members are also eligible to receive the same tuition reduction for Drexel's online programs through this educational collaboration. Pursuing a degree has never been easier, or more affordable!

Delivered fully online, Drexel's programs are highly interactive and are designed for working professionals seeking to earn a degree or additional certification. The online programs follow the same high academic standards and lead to the same quality degrees as on-campus- with no commuting or career interruption.

To learn more about this collaboration and Drexel’s online programs, please visit www.drexel.com/socra, call Drexel toll-free at (866) 440-1948, or e-mail your questions to socra@drexelelearning.com.

To qualify for these reduced tuition rates, members and their spouses should use "SOCRA" as your affiliation code when you complete an application.

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Duke University

Master of Science in Nursing with focus in Clinical Research Management
(Can be completed in-residence or online)
Post Master Certificate in Clinical Research Management
(Can be completed in-residence or online)

www.nursing.duke.edu (Select "Curriculum")

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Durham Community College

SoCRA was involved in the development of a structured two-year degree program in clinical research offered at Durham Community College in Durham, NC. In addition, this college offers two certificate programs, one for the new clinical research professional and one for the advanced clinical research professional. Evening and distance learning courses are available.
Contact: Melissa Ockert, Program Director
(
919) 686-3309
ockertm@gwmail.dtcc.nc.us

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GateWay Community College

16 credit hour college CRC certificate program

www.gwc.maricopa.edu/curriculum/clinical_research_coordinator/

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George Washington University

George Washington University - Washington DC metro online B.S. programs:

CLINICAL MANAGEMENT AND LEADERSHIP, BACHELORS- Online Program
CLINICAL RESEARCH ADMINISTRATION, BACHELORS - Online Program

Contact: Click Here for Web Page

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Humber College Institute of Technology & Advanced Learning (Canada)

Humber has two excellent programs Clinical Research and Regulatory Affairs, which accept applicants with BSC and higher degrees.

Contact: Click Here for Web Page

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LaSalle University

LaSalle University, Philadelphia, PA

Graduate certificate in Clinical Research

Contact one of the following people regarding the clinical research operations certificate program:

Janice Beitz, PhD, Dir. Graduate Program
(215) 951-1413
beitz@lasalle.edu
 
William Hirschhorn
doct@astro.temple.edu

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MGH Institute of Health Professions

MGH Institute of Health Professions, an educational affiliate of Massachusetts General Hospital, offers both on site and distance learning programs culminating in either Master of Science or a Certificate of Advanced Study. Additionally, two courses may be taken as a non-degree student.

Contact:
M.S. Program Manager of Clinical Investigation
(617) 724 6362
E-mail: ci@mghihp.edu
Website: www.mghihp.edu

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New York Medical College

New York Medical College, Valhalla, NY offers a 12 credit Graduate Research Certificate Program and a M. S. in Clinical Research Administration.

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Temple University

Temple University Philadelphia, PA
(215) 591-2333

Contact one of the following people:

Wendy Lebing
wlebing@temple.edu
 
William Hirschhorn, Dir School of Pharmacy
qara@temple.edu

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University of California, San Francisco Nursing Program

University of California, San Francisco Nursing Program offers a master's level clinical research program. (Other UC schools also offer this program; therefore contact your local campus.) University of CA Santa Cruz offers a certificate program in clinical trials design and management.

Contact: Betina Oeike
(408) 566-4552
betina@ucsc-extension.edu

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University of Medicine and Dentistry of New Jersey

Certificate in Clinical Recruitment Sciences

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University of Minnesota

University of MN offers a major in clinical research.

Contact:

Director Stephen Glasser
Click Here for Web Page

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University of Washington

This fall, the University of Washington will offer a Certificate Program in Clinical Trials, a nine-month, evening program designed for people who want to enter the field or who want to move up its ranks.

The program consists of three courses, covering the laws and guidelines affecting clinical trials, design and implementation of a trial, as well as the business and management issues of clinical research. Students will study everything from research ethics and informed consent, to trial implementation and monitoring, to budgeting and public relations. The emphasis of the program is real-world, practical information that is not always covered in academic training.

For more information on the program, visit:

http://www.outreach.washington.edu/extinfo/certprog/cli/cli_main.asp

For media questions about the program, contact:

Shaun Bennett, UW Educational Outreach program manager.
206-685-6515
sbennett@ese.washington.edu

Erica Jonlin, PhD, program instructor and a clinical research coordinator at the UW.
206-221-6612
ejonlin@u.washington.edu

Marcia Koren, program instructor and manager of clinical trials and Dendreon Corporation.
206-285-9103
MKoren@Dendreon.com

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Advanstar Communications

Advanstar Communications publishes the journal Applied Clinical Trials. The December 2001 issue includes a directory that identifies and describes academic programs in clinical Research.

Contact:

www.actmagazine.com
(218) 723-9259

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What salary might I expect in clinical research?

See www.salary.com, where you can select a position and location and receive the latest results of their studies.

Click Here for the SoCRA Salary Survey (PDF, 506KB).

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GCP Fact or Fiction Review Document

Click Here for the review document (PDF, 74KB).

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GCP Questions for The FDA

Send the FDA your GCP Question:
gcpquestions@oc.fda.gov

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