Clinical Research Coordinator
About The Position
Vascular Breakthroughs manages clinical trials for a growing group of vascular surgeons. The trials include device and drug studies, ranging from first-in-human pilot studies and IDE trials to post-market registry trials. The organization uses a clinical trial management system to store subject and regulatory binders electronically, facilitating remote trial management and regulatory compliance. The Clinical Research Coordinator supports clinical trial start-up activities and coordinates patient enrollment across The Vascular Care Group (TVCG). The role is 80% in person and 20% remote, with regular travel between TVCG sites. Primary work locations are Worcester, Lowell, and Wellesley, with additional sites added as needed.
Requirements
- Bachelor’s degree in biological sciences, health sciences, social sciences, or another medical field, or an equivalent combination of education and experience.
- Clinical experience in a surgical specialty field is required; vascular experience is preferred.
- Knowledge of medical terminology.
- Computer skills, including accessing Electronic Medical Records and Electronic Data Capture systems.
- Strong attention to detail, facility with computer systems, ability to work independently, and willingness to take on challenges.
Nice To Haves
- 3–5 years of experience in a clinical research capacity or knowledge of clinical research.
- Vascular clinical experience.
- Patient-facing experience.
Responsibilities
- Organize and facilitate weekly meetings with clinic and OBL staff across practice sites to review schedules and identify eligible patients.
- Assist with assessing patient records to identify patients eligible for specified clinical research protocols.
- Assist with monitoring patients for adverse reactions to study treatment, procedures, or medication; notify appropriate clinical professionals to evaluate patient response, determine the status of complications, and provide the appropriate level of care.
- Assist with device accountability, including transporting or shipping devices to practice sites for procedures as needed.
- Assist with gathering regulatory documents for new trials and attend training sessions for new trials.
- Assist with collecting source data for entry into the CTMS, entering source data into EDC systems, responding to queries, and working with monitors to resolve queries.
- Assist with adding and training additional personnel in Massachusetts to work on clinical trials.
- Support compliance with Institutional Review Board (IRB), FDA, federal, state, and industry sponsor regulations.
- Assist in building electronic templates in the CTMS for new trials to create eSource.
- Travel regularly to TVCG offices to support trial start-up and enrollment activities.
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What This Job Offers
Job Type
Full-time
