Clinical Research Coordinator II
- Participates in the design and monitoring of clinical trials.
- Analyzes and evaluates clinical data gathered during research.
- Ensures compliance with protocol and overall clinical objectives.
- Relies on experience and judgment to plan and accomplish goals.
- Performs a variety of complicated tasks.
- A wide degree of creativity and latitude is expected.
- Requires a BS, RN, or BSN degree or equivalent
- Minimum of 5 years of experience in the field or in a related area.
- Knowledge of FDA regulatory requirements is required.
- Familiar with a variety of the field's concepts, practices, and procedures.
- NOTE: Required to be a Registered Nurse licensed to practice in the state of Maryland and Commission for Case Manager Certification (CCNC) certification, who are skilled and qualified in nursing procedures to include, but not limited to phlebotomy and the administration of experimental vaccines and other parenteral therapeutics as per specific protocol guidance in accordance with the 21 Code of Federal Regulation (CFR) 11, 50, 54, 56, 312, and 314. All qualified personnel shall meet all credentialing requirements in accordance with Clinical Trial Monitoring of FDA Regulated Clinical Trials Policy (Command Policy Memorandum 2011-59), Army Regulation (AR) 40-68, Clinical Quality Management, issued 26 Feb 2004, WRAIR Command Policy Memorandum 2017-45, “Walter Reed Army Institute of Research Quality Policy,” and USAMRMC Command Policy 2010-07, “Licensure, Credentialing and Privileging (LCP)” issued 10 Mar 2015, or revisions thereof.
ICON Government and Public Health Solutions specializes in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with a wide array of research, regulatory, and sponsor services both within the US and around the globe and respond rapidly to global health crises.