Clinical Research NurseOverviewThis role is responsible for supporting clinical trials start-up activities and coordinating enrollment of patients across The Vascular Care Group ("TVCG") in clinical trials.
Willingness to drive between TVCG sites to fulfill research requirements required; primary locations for work will be Wellesley, Plymouth, and Hyannis, with additional sites added as necessary. Role is comprised of 80% in person work, 20% remote.
Responsibilities- Organize and facilitate weekly meetings with clinic and OBL staff across all practice sites to examine schedules and identify eligible patients
- Assist with assessing patient records to identify patients who are eligible to participate in specified clinical research protocols
- Assist with monitoring patients for adverse reactions to study treatment, procedure, or medication and notify appropriate clinical professionals to evaluate patient response, identify the status of complications, & provide the appropriate level of care
- Assist with device accountability (transport or ship devices to practice site for procedures) on an as needed basis
- Assist with gathering required regulatory documents for new trials and attend training sessions for new trials
- Assist with collecting source data to enter into CTMS, enter source data into EDC systems, respond to queries and work with monitors to resolve queries
- Assist with adding/training additional personnel in MA to be delegated to work on the various clinical trials
- Support activities to ensure compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state, and industry sponsor regulations
- Assist in building electronic templates into CTMS for new trials to create eSource
- Regular travel to TVCG offices to assist in trial start-up activities and enrollment activities
Education/Experience- Minimum of ADN/LPN. BSN preferred.
- 3-5 years of experience in a clinical research capacity or knowledge in clinical research preferred
- Clinical experience in a surgical specialty field required; vascular preferred
- Patient facing experience perferred
- Knowledge of medical terminology required
- Computer skills required (much of the work involves accessing Electronic Medical Records and Electronic Data Capture systems)
- Must be detailed oriented, facile with computer systems, able to work independently and willing to take on challenges
