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CRP
Certification, Preparation, and Review Course
Program Information
Registration Fees:
Non-member fee includes membership for one year. Continuing Education Credit Hours: SoCRA designates this educational activity for a maximum of 6.5 Continuing Education Credit Hours for SoCRA CE, Nurse CNE, and Physician Category 1 CME. Accreditation Statements:
SoCRA Course Series: 500 The CCRP Certification Examination
is offered
throughout the year.
Enrollment in the SoCRA Certification Exam requires a separate application and fee. Please visit HERE for more information. Program DescriptionGoal: The Society of Clinical Research Associates (SoCRA) recognizes Certified Clinical Research Professionals (CCRPs) as clinical researchers who meet an internationally accepted standard of knowledge, education and experience. The purpose of this workshop is to assist the participant in preparing for the SoCRA examination for the Certified Clinical Research Professional examination and to review regulations, policies, and procedures appropriate to the clinical research environment. Please see the Certification page for a separate examination application. Objective: The goal will be accomplished through lecture, discussion and practical application facilitated by certified clinical research professionals with combined clinical research experience of more than 20 years. Information will be presented and discussed regarding the conduct of clinical trials; regulatory guidelines regarding IRB oversight and human research protections; ethical issues in clinical research; and workshops will stress the ability to follow directions and practices related to abstracting information and completing case report forms and other records. Learning Objectives: Upon completion of the workshop, the attendee should be able to:
How to RegisterPlease Note: This enrollment registers you in the SoCRA Certification, Preparation and Review Course ONLY. Enrollment in the SoCRA CCRP Certification Exam requires a separate application and fee. Visit HERE for more information. Click HERE to register online!* Click Here to view/print the Course Application in Adobe PDF format.* *SoCRA REGISTRATION POLICIES/INFORMATION:
Click Here to view/print the Course Late Transfer Form (in PDF format). AgendaClick Here to view/print the Course Agenda in Adobe PDF format. Faculty Bios:Course faculty would be one of the following instructors. George D’Addamio is President of PharmConsult, Inc., a consulting company in Atlanta, GA. During 8 years at SmithKline & French Laboratories (now Glaxo SmithKline), Dr. D’Addamio was responsible for preparing protocols, case report forms, integrated study reports, and regulatory submissions in Clinical R&D and Medical Affairs. As Scientific Manager, Clinical R&D, he was responsible for coordinating clinical research programs in Canada, Latin America, and the Pacific conducted under the US IND. In Medical Affairs, he managed operational groups responsible for medical writing, clinical monitoring, and safety reviews and quality control checks of CRFs. After leaving SK&F, Dr. D’Addamio worked for a CRO for 1.5 years before forming PharmConsult in 1987. Previous consulting experience includes project management, data management, statistical services, and medical writing. Currently, PharmConsult specializes in preparation of clinical development documents in various therapeutic areas for domestic and foreign pharmaceutical companies. Susan Devine, CCRP is Senior Manager of the Clinical Trial Support Unit of Hematology/Oncology at the Hospital for Sick Children in Toronto and previously Clinical Trials Manager at Montreal Children’s Hospital, McGill University. Involved in pediatric hematology, oncology and bone marrow transplant clinical trials for more than twenty three years, she has experience in all facets of clinical trial facilitation including study initiation, case report form development, regulatory compliance and monitoring. Ms. Devine currently serves as Chair of the Children’s Oncology Group CRA Discipline and is a member of the COG Executive Committee. She is a member of the American Society of Clinical Oncology and is also a SoCRA Board member. Joanne Goldberg, M.Sc, pht, CCRP is the Associate Scientific Director at the Quebec Funding Agency for Health Research (the Fonds de la recherche en santé du Québec) in Montreal, Canada. In her current position, she is also the primary contact for all Agency matters related to clinical research. She holds a Master of Science degree in Biomedical Sciences from the University of Montréal as well as a Bachelor of Sciences degree in Physical Therapy from the same institution. She has been involved in clinical research for the last 16 years and has held many positions including Director of Training, Director for Clinical Site Network Management, Director of Quality Management Systems, Senior Project Manager, Senior Study Coordinator, as well as Investigator. Her expertise is primarily in quality management, training in Good Clinical Practices and Ethics, study methodology, writing and implementing standard operating procedures as well as in team management. She is responsible for the French language translation and administration of the Society of Clinical Research Associates’ (SoCRA) certification examination and Preparatory Course. Joanne is a Past President of SoCRA. She is the author of numerous publications and is often invited to speak on her various areas of expertise at international conferences. Carolyn E. Rugloski, MSc, CCRP, is the Associate Director, Clinical Operations at the University of California at San Francisco ITN (Immune Tolerance Network). Ms. Rugloski has over twenty-five years of clinical trial experience serving in a management role in the clinical research areas of data management, monitoring, training, project management, quality assurance, and business development. She has dedicated herself over the years to the training of clinical trial professionals through SoCRA and other educational organizations. Recognized internationally as a Good Clinical Practice (GCP) Trainer subject matter expert, Ms. Rugloski has lectured in North America, Europe, and the Pacific Rim. Ms. Rugloski is a past member of the SoCRA Board of Directors and continues to assist in the development and delivery of SoCRA events. Kathi Durdon, MA, CCRP, is a Clinical Operations Associate with device manufacturer, Welch Allyn, Inc., based in Skaneateles Falls, NY. Previously, Ms. Durdon directed the Clinical Trials Office at State University of New York (SUNY) Upstate Medical University in Syracuse, NY. Kathi has been responsible for development of medical conferences and comprehensive education programs as well as resource development and budget negotiation throughout her 15-year tenure at Upstate. As CRA at Welch Allyn, she provides GCP and GMP training, SOP development and all aspects of project management for device clinical trials. Kathi is certified by the Society of Clinical Research Associates (SoCRA) as a Clinical Research Professional, speaks frequently at SoCRA courses, is a member of SoCRA’s Board of Directors and is the New York State Chapter Chair. Ms. Durdon holds Bachelor of Arts degrees in both English and Anthropology from the State University of New York (SUNY) Potsdam College as well as a Master of Arts degree in Business Policy from the State University of New York (SUNY) Empire State College. How to Host This CourseThe CRP Certification, Preparation, and Review Course Host Application is available in Microsoft Word format.
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