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 Monitoring Visit, the responsibilities of the CRA and CRC including pre- and post-Monitoring Visit activities
- 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
- Nurses
- 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..
Erica Elefant
Karen Gilbert, B.S., C.C.R.A.
Beth D. Harper, B.S., M.B.A.
Hillary Kimes, R.N., M.S.N., C.C.R.A., C.C.R.C
Elizabeth Ronk Nelson, M.P.H
Marcellina N. Oparaoji, Ed.D., B.S.N., R.N., C.C.R.P.
Lily Romero, P.A., C.C.R.C.
Sandra “SAM” Sather, M.S.,B.S.N., C.C.R.A., C.C.R.C.
Jackie Stader, C.O.T., C.C.R.C.
Jennifer Stanford, R.N., M.S.N.
Kimberly Turner, CMA, AS, BHS, CRAClick here for complete trainer biographies
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.
- The Clinical Investigator, Site Selection & Budget Negotiation
- Clinical Study Protocol Elements & Statistical Considerations
- Institutional Review Board, the Consent of Human Volunteers
- Interactive Exercise I
- Study Monitoring, Data Management and the Study Initiation Visit
Day 3: 8:30 a.m. – 5:00 p.m.
- Safety Reporting: Definitions & Reporting Requirements
- Accountability for the Test Article & the Termination Visit
- Regulatory Compliance & Quality Assurance: Audits & Inspections
- Managing Your Time & the Interview
- Interactive Exercise II
- 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.
Click here for our seminar cancellation policy
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# 0778-0000-10-016-L01-P. Released: 6/10.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.