This beginner course provides an excellent introduction to clinical research and the job responsibilities of Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs). It explores topics relevant to those considering a career as an entry-level CRA or CRC. Specifically, this course is appropriate for individuals seeking a new career or career change, but don’t know which job track within clinical research to pursue. The course includes an appendix of time management and interviewing tips.
- Describe the investigational product development process
- Review FDA regulations and ICH guidelines for Good Clinical Practices (GCPs)
- Understand the roles and responsibilities of the Clinical Research Associate and the Clinical Research Coordinator before, during, and after a clinical trial
- Identify the requirements of the Investigator in supervising clinical research
- Discuss the role of an Institutional Review Board,its composition, and responsibilities in the clinical trial process
- Define the informed consent process, the elements of the informed consent document, and the role of the CRA and the CRC in the process
- Describe an overview of the different types of Monitoring Visits, along with the responsibilities of the CRA and CRC including preparation, activities, and monitoring visit follow-up
- Define source documents and Case Report Forms (CRFs) in relation to CRF completion and source document verification
- Describe definitions related to safety management, identification of adverse events, and reporting requirements
- Compare and contrast regulatory inspections and quality assurance audits of investigative sites
- Aspiring Clinical Research Coordinators
- Aspiring Clinical Research Associates – In-house or Field-based
- College Students and New Graduates in a Scientific Field
- NOTE: This course is also appropriate for CRAs or CRCs with less than 6 months experience
The course will be led by one of the following instructors:
Linda Carter, R.N., B.S.N.
Nikki Christison, B.S., C.C.R.A.
Beth D. Harper, B.S., M.B.A.
Elizabeth Ronk Nelson, M.P.H
Lily Romero, P.A., C.C.R.C.Sue Torchio, R.N., B.S.N.
Click here for complete trainer biographies
Day 1: 8:30 a.m. – 5:00 p.m.
- Introduction to Clinical Research
- Clinical Research Team: Roles & Responsibilities
- Investigational Product (IP) Development
- Good Clinical Practice: FDA Regulations, FDA Guidances, and ICH
Day 2: 8:30 a.m. – 5:00 p.m.
- The Clinical Study Protocol and Study Feasibility
- The Principal Investigator, Site Selection, and Study Initiation
- Institutional Review Board, the Consent of Human Volunteers, and HIPAA
- Safety Reporting: Definitions & Reporting Requirements
Day 3: 8:30 a.m. – 5:00 p.m.
- IP Accountability, Essential Documents, and Routine Monitoring Visits
- Source Document Verification, Data Management, and the Trial Close-out Visit
- Interactive Exercises I and II
- Regulatory Compliance & Quality Assurance: Audits & Inspections
- Case Study Reviews - Adverse Events, Protocol Modifications, Study Feasibility, and Monitoring Visit Scenarios
- Site Selection Exercise
- IP Accountability and Documentation Exercise
- Source Document Verification Simulation
- Informed Consent Review Activity
- Case Report Form Completion Simulation
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 22.5 hours (2.25 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE# 0778-0000-13-011-L01-P. Released: 2/13.
This continuing nursing education activity was approved by the New Jersey State Nurses Association, an accredited approver by the American Nurses Credentialing Center's Commission on Accreditation.
Approval Number: 7447-12/13-15. 21 Contact Hours
Participants will receive 21 hours of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.