This beginner course provides an excellent introduction to clinical research and the job responsibilities of Clinical Research Associates and Clinical Research Coordinators. It explores topics relevant to those considering a career as an entry-level monitor or site coordinator. 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.
- Describe the drug development process
- Review FDA regulations and guidelines for Good Clinical Practices
- Define the roles and responsibilities of the Clinical Research Associate and the Clinical Research Coordinator
- Describe the role of the Investigator in 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 required elements for the informed consent, document, exceptions for obtaining consent, and the role of the CRA and the CRC in the process
- Describe an overview of different types of Monitoring Visit, along with the responsibilities of the CRA and CRC including pre- and post-Monitoring Visit activities
- Define source documents and Case Report Forms (CRFs) in relation to source document verification
- Identify strategies to manage clinical research site activities
- Review the identification and management of issues during clinical trial
- Aspiring Clinical Research Coordinators
- Aspiring Clinical Research Associates – In-house or Field-based
- College Students
- New College Graduates - Any Discipline
- 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:
Nikki Christison, B.S..
Karen Gilbert, 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.
Jackie Stader, C.O.T., C.C.R.C.
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Day 1: 8:30 a.m. – 5:00 p.m.
- Acronyms & Terminology
- FDA Regulations and Guidelines for Good Clinical Practice
- Clinical Research Team: Roles & Responsibilities
Day 2: 8:30 a.m. – 5:00 p.m.
- Institutional Review Board, the Consent of Human Volunteers and HIPAA
- The Clinical Study Protocol and the Study Initiation Process
- Safety Reporting: Definitions & Reporting Requirements
Day 3: 8:30 a.m. – 5:00 p.m.
- IP Accountability, Essential Documents and Routine Monitoring
- Source Document Verification, Data Management, and the Trial Close-out Visit
- Interactive Exercises I and II
- Regulatory Compliance & Quality Assurance: Audits & Inspections
- Managing Your Time & the Interview
- Case Study Reviews
- Source Document Verification Simulation
- Informed Consent Review Simulation
- 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 Elizabeth Andrews 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 mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-13-011-L01-P. Released: 2/13.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.