The Clinical Research Coordinator is responsible for day-to-day coordination of intervention Phase I-III clinical trials. The position will perform all tasks relating to the start-up, management and close-out of studies including: preparing IRB documentation, maintaining study records, screening patients for eligibility,
tracking patient visits, and abstracting and reporting data. The Coordinator will work on multiple studies for one or more investigators, and report regularly to those investigators on the progress of the studies. The CRC II reports directly to the Clinical Research Manager.
- Prepares study start-up documentation including IRB documents, eligibility checklists, study-specific clinic orders and study calendars (if not completed by the Clinical Research Manager)
- Screens and registers patients; ensures eligibility requirements are met
- Assures consent forms are completed correctly and in entirety
- Schedules study related clinic procedures such as blood draws, infusions and imaging according to protocol requirements; coordinates with clinic staff to ensure proper documentation and timing of research-related procedures
- Abstracts data from medical records to complete study-specific CRFs (electronic and/or paper) in timely and accurate manner; maintains shadow chart with source documents
- Collaborates with study sponsor/consortium delegate to assist with study monitoring visits and responds to findings
- Creates and maintains patient tracking tools; communicates status to investigators, management and relevant departments
- Manages study documentation throughout study life cycle including IRB annual renewals, modifications, patient study charts and regulatory binder
- Liaises with study sponsor, investigator(s) and members of study team to communicate timelines, expectations and study status
- Acts as a resource to physicians, investigators, other staff members, and other organizations regarding protocol procedures, data collection requirements and other study related operations
- Keeps knowledge and skills current by completing mandated training and attending meetings with the study team and the Consortium, such as the monthly coordinator meeting, relevant brown bags, faculty and administrative presentations, and other opportunities of interest
- 2 -3 years experience in trial coordination and management is critical to succes in this position, given volume, complexity, and compliance requirements in support of clinical trials.
- Undergraduate degree is mandatory, with master's degree preferrable and/or equivalent experience at that level.
- Ability to work in teams and independently, flexible hours at times in support of clinical trials and regulatory and related compliance.
- Ability to work with faculty and staff, including clinicians, and research scientists.
- Attention to detail and project management skills and experience.
- Well-organized and ability to juggle numerous tasks, often with conflicting and competing deadlines.
- Experience with study Data systems (Medidata RAVE, etc.) is strongly preferred.
We are a VEVRAA Federal Contractor.
If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2193624-2647-521