Philadelphia University + Thomas Jefferson University

Clinical Research Coordinator Workshop

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 the links to the topic slides and the presenters' contact information:

To access the slides, click on [Go To Confluence] above and log in with your TJU campus key and password.

STUDY DESIGNS AND TYPES, CLINICALTRIALS.GOV, & STATISTICS
Study Development and Design

Suzanne Adams, RN MPH
Director, Clinical Operations and Education
Jefferson Clinical Research Institute (JCRI)

Bridget Toroni, MS
Clinical Research Coordinator III
Jefferson Clinical Research Institute (JCRI)

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
Director of Clinical Trials
Rothman Institute

Karah Williams, MSW
Clinical Research Coordinator III
SKCC Clinical Research Organization

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
Manager of Education and Training
Jefferson Clinical Research Institute (JCRI)
ELECTRONIC REGULATORY 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
Manager of Education and Training
Jefferson Clinical Research Institute (JCRI)

Cynthia Y. Perez, BS CCRP
NCTN Manager, Regional Network Office
SKCC Clinical Research Organization

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

Jessica Rinaldi, CCRP
Clinical Research Manager, Neurology
Farber Institute for Neurosciences

Investigational Product Accountability in Outpatient Clinical Trials
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