This refresher course provides additional training for the clinical research coordinator (CRC) with greater than three years of experience. We will start out with a review of the key governing regulations and guidelines in clinical research, and will then discuss trends, management issues and the financial impact of clinical research on the research site. We will also cover inspection preparation, as well as CAPA planning and implementation. This course will also focus on investigator responsibilities and developing processes that will ensure adequate investigator oversight.
Understand the relevant regulations and guidelines
Discuss trends in clinical research
Prioritize study management activities
Discuss study management issues
Describe financial impact and trends
Prepare for an inspection
Develop Corrective and Preventive Actions Plans (CAPA)
Ensure adequate training and documentation of training of clinical research staff
This course has been developed for the individual, CRC, nurse coordinator, Site Manager, investigator who has a solid background in the CFRs, ICH E6 Guidelines, and either involved in or manages the daily operation of clinical research at a trial site. This course can be beneficial to the CRA and members of the sponsor/CRO industry.
The course will be led by one of the following instructors:
Nikki Christison, B.S.
Karen Gilbert, B.S., C.C.R.A.
Lily Romero, P.A. C.C.R.C.
Jackie Stader, C.O.T., C.C.R.C.
Kimberly Turner, CMA, AS, BHS, CRA
Click here for complete trainer biographies
Day 1: 8:30 a.m. – 5:00 p.m.
- Recap, including updates, of CFRs, ICH, GCP and relevant guidance documents
- Trends and changing landscape in clinical research
- Study Management: Prioritizing
- Study Management: Financial
- Training the Clinical Research Staff
- FDA inspections/Preparing for an Inspection
- Corrective and Preventive Action Plans/ Case Study
- Case study
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.
Click here for our seminar cancellation policy
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.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 7 hours (0.7 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# 778-000-09-047-L01-P. Released: 3/10.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.