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
Discuss FDA regulations and guidelines for Good Clinical Practices
Define the roles and responsibilities of the Clinical Research Associate and the Clinical Research Coordinator
Discuss the role of an Institutional Review Board, its composition and responsibilities in the clinical trial process
Define the informed consent process, basic and additional elements required in an informed consent, 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 preparation, format, content, and post-Monitoring Visit activities
Define source documents and Case Report Forms (CRFs) in relation to the source document verification
Identify strategiesto manage clinical research site activities
Review the identification and management of issues during a clinical trial
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:
Erica Elefant
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.
Jennifer Stanford, R.N., M.S.N.
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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.
- 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 Mangement and the Study Initiation Visit
Day 3: 8:30a.m. – 5:00 p.m.
- Saferty Reporting: Definitions & Reporting Requirements
- Accountability for the Test Article & the Termination Visit
- Regulatory Compliance & Quality Assurance: Audits & Insepections
- Managing Your Time & the Interview
- Interactive Exercise II
August 16-18, 2010
San Francisco, CA
Course #SCOF0810
Hilton San Francisco
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Register Early and Save!
$1,695 by July 16
$1,895 after July 16
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 15 hours (1.5 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.
The New Jersey State Nurses Association (NJSNA) is accredited by the American Nurses Credentialing Center (ANCC) Commission on Accreditation of the American Nurses Association as an approver of continuing education for nursing. As an accredited body, NJSNA has approved this program for 21 Contact Hours. Approval Number: 6682-2/08-10.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.