Clinical Research Coordinator Workshop
Contact
833 Chestnut Street
Suite 900
Philadelphia, PA 19107
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Clinical Research Coordinator Workshop is a two-day, interactive workshop, presented by subject matter experts. It is designed to deepen understanding and improve performance of safe, ethical and compliant clinical research in the academic and clinical setting. The workshop includes a comprehensive review of the best practices, skills, and tools necessary to implement successful clinical research that incorporates Good Clinical Practice (GCP) guidelines.
Below are links to the topic slides presented at the previous Workshop and the presenters' contact information:
| Study Designs and Types, Clinicaltrials.gov, & Statistics | |
|---|---|
| Study Development and Design | Suzanne Adams, RN MPH Bridget Toroni, MS |
| ClinicalTrials.gov | Melissa McCarey, MPH Education Coordinator Jefferson Clinical Research Institute (JCRI) |
| Study Feasibility, Readiness, & Recruitment and Retention | |
| Assessing Study Feasibility, Study Readiness, and Subject Recruitment and Retention | Tiffany Morrison, MS CCRP Karah Williams, MSW |
| Informed Consent | |
| Informed Consent - Documentation | Patrick Herbison, MEd CIP Assistant Director Office of Human Research (OHR) |
| Informed Consent Process | Kathleen O'Malley, RN BSN CCRP Director of Education and Training Jefferson Clinical Research Institute (JCRI) |
| Electronic Regulary Documents | |
| Organizing Electronic Regulatory Documents | Suzanne Jorfi, BS CCRP Regulatory Manager, Proocol Support Unit SKCC Clinical Research Organization |
| AES, UAPS, and Protocol Deviations | |
| Adverse Events, Unanticipated Problems, and Protocol Deviations | Kathleen O'Malley, RN BSN CCRP Cynthia Y. Perez, BS CCRP |
| Audits | |
| FDA Inspections and Sponsors Audits | Christine Jerome, BS CCRP Director, Quality Assuranace & Process Improvement Unit Office of Human Research (OHR) |
| Internal Audits | Patrick Herbison, MEd CIP Assistant Director Office of Human Research (OHR) |
| Drug Supply Management & Accountability | |
| Promoting Oral Therapy Adherence in Clinical Trials | Teresa Cardoso, MS BSN RN Clinical Trial Educator SKCC Clinical Research Organization |
| Investigational Product Accountability in Outpatient Clinical Trials | Jessica Rinaldi, CCRP Clinical Research Manager, Neurology Farber Institute for Neurosciences |
| Project Management | |
| Project Management | Nancy Wintering, LCSW CCRP Assistant Director of Research Myrna Brind Center of Integrative Medicine |
| Managing Up | Kathleen O'Malley, RN BSN CCRP Manager of Education and Training Jefferson Clinical Research Institute (JCRI) |
*Updated November 1st, 2017