Philadelphia University + Thomas Jefferson University

Clinical Research Fundamentals

Clinical Research Fundamentals is a full-day course, presented three times per year.

This program is targeted toward clinical research personnel that are new to clinical research (18 months or less).  The content will enhance the understanding of the role and responsibilities of the clinical research coordinator by providing foundational knowledge. Attendees will acquire the tools necessary to improve performance of safe, ethical and compliant clinical research in the academic and clinical setting.

Below are the topics that are presented along with the presenters' contact information.

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

IDENTIFY AND LOCATE YOUR RESOURCES
Identify and Locate Your Resources

Tiffany Morrison, MS CCRP
Director of Clinical Trials
Rothman Orthopaedics

Kathleen O'Malley, RN BSN CCRP
Manager of Education and Training
Jefferson Clinical Research Institute (JCRI)

GOOD CLINICAL DOCUMENTATION
Good Clinical Documentation Teresa Cardoso, MS BSN RN
Clinical Trial Educator
SKCC Clinical Research Organization
ADVERSE EVENTS, UNANTICIPATED PROBLEMS, AND SAFETY REPORTING
AEs, UAPs, and Safety Reporting

Kathleen O'Malley, RN BSN CCRP
Manager of Education and Training
Jefferson Clinical Research Institute (JCRI)

MONITOR VISITS AND AUDIT READINESS
Monitor Visits and Audit Readiness Christine Jerome, BS CCRP
Director, Quality Assuranace & Process Improvement Unit
Office of Human Research (OHR)
INFORMED CONSENT PROCESS
Informed Consent Process Kathleen O'Malley, RN BSN CCRP
Manager of Education and Training
Jefferson Clinical Research Institute (JCRI)
CLINICAL TRIAL BILLING AND EPIC
Clinical Trial Billing and Epic Jenny Campbell, MS MBA
Assistant Director, Clinical Research Billing Compliance
JCRI Business Operations
INVESTIGATIONAL PRODUCT MANAGEMENT
Investigational Product Management Jessica Rinaldi, CCRP
Clinical Research Manager, Neurology
Farber Institute for Neurosciences
CERTIFICATION AND DEVELOPING QUALITY
Certification and Developing Quality Nancy Wintering, LCSW CCRP
Assistant Director of Research
Myrna Brind Center of Integrative Medicine

*Updated February 7th, 2018