This course provides an in-depth survey of the roles and responsibilities of the investigator site Clinical Research Coordinator (CRC). The course begins with an overview of the drug development process and regulatory environment in which the CRC operates. From there, critical CRC responsibilities will be discussed, including patient recruitment and retention, informed consent adverse event reporting, and investigational product accountability. The CRC’s role at the site will be explored, from study start-up through site close-out, and all of the activities, site visits, and documentation that occur along the way. Finally, site audits and inspections will be reviewed, with an emphasis on the CRC’s role in that process.
Discuss the CRC role in the development of new drugs
Describe “letter” and the “spirit” of FDA regulations, ICH guidelines, and ethical considerations pertinent to conducting clinical trials
- Prepare for all sponsor site visits
Develop strategies for recruiting and retaining study subjects
- Review the reporting requirements of adverse events
- Employ study documentation requirements and standards for collecting and reporting clinical trials data
Develop strategies for preparing, implementing, and managing clinical studies
Identify strategies for issues management include root cause analysis and corrective and preventive action plans
Prepare your site for an FDA inspection
Clinical Research Coordinators (CRCs) with limited experience in managing industry-sponsored investigational drug studies
Experienced Coordinators seeking a greater understanding of federal regulations and ICH requirements and to enhance their skills to more efficiently and effectively manage their studies
CRAs who are interested in gaining a better understanding of the CRC and investigator role
The course will be led by one of the following instructors:
Erica Elefant
Nikki Christison, B.S.
Gary B. Freeman, M.S., C.C.R.A. .
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., N.R., 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.
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Day 1: 8:30 a.m. – 5:00 p.m.
- Overview of Drug Development and Good Clinical Practice: Terminology; phases of drug development and introduction to GCP
- The Clinical Research Team: Roles and responsibilities; appropriate delegation of investigator responsibilities
- The Site Selection Process: Criteria for site selection; planning and preparing for the site qualification visit
- IRBs and the Protocol Approval Process: IRB membership and operational requirements; sponsor-site-IRB relationships
- Study Start-up and Study Initiation Visits: Preparations and activities
- Subject Recruitment and Retention: Advertising and payment guidelines; strategies for successful recruitment
- The Informed Consent Process: Documentation requirements; execution considerations
Day 2: 8:30 a.m. – 5:00 p.m.
- Study Implementation and Study Documents: Regulatory files, source documents and case report forms; records retention
- Monitoring Visits: Preparation and activities; simulation exercise
- Managing and Reporting Adverse Events: Definitions and reporting requirements; differences in various sponsor policies
- Drug Accountability and Close-Out Visits: Preparation and activities
Budgets: Development of study budgets; coordinator’s role in negotiation
- FDA Audits: Mechanics of an FDA inspection; common audit findings
- Time Management and Prioritization: Simulation exercise
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# 0778-0000-10-006-L01-P. Released: 9/10.
This continuing nursing education activity was approved by New Jersey State Nurses Association, an accredited approver by the American Nurses Credentialing Center’s COA. Approval Number: 7051-12/10-12. 13.75 Contact Hours.
There is no commercial support for this activity. Speakers have declared that they have nothing to disclose. Accredited status does not imply endorsement by Barnett International, NJSNA or ANCC of any commercial products or services.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.