Job Title: Clinical Research Coordinator
Location: Wellesley, Plymouth, Hyannis (with additional sites as needed)
Job Type: Full-time, 80% in-person, 20% remote
Vascular Breakthroughs manages a growing portfolio of clinical trials in partnership with vascular surgeons. These trials include a mix of device and drug studies, ranging from early-stage pilot studies and IDE trials to post-market registry trials. The Clinical Research Coordinator will support the start-up activities of clinical trials and coordinate patient enrollment for The Vascular Care Group (TVCG) across multiple practice sites. Utilizing an advanced clinical trial management system (CTMS), we streamline the management of subject and regulatory binders electronically, enhancing remote management and ensuring compliance.
This position requires travel between the TVCG sites (Wellesley, Plymouth, Hyannis) to support research activities, with the majority of work being in-person (80%) and a portion remote (20%).
Trial Coordination & Patient Enrollment:
Organize and facilitate weekly meetings with clinic and Office-Based Lab (OBL) staff at all practice sites to review schedules and identify eligible patients for clinical trials.
Patient Record Assessment:
Assist in reviewing patient records to identify those eligible for clinical research protocols and ensure their participation in relevant trials.
Monitoring & Adverse Reaction Management:
Assist in monitoring patients for adverse reactions to study treatments, procedures, or medications. Notify appropriate clinical professionals to evaluate patient responses and manage any complications.
Device Accountability & Logistics:
Assist with device accountability, including transporting or shipping devices to practice sites as needed for clinical procedures.
Regulatory Documentation & Compliance:
Assist with gathering required regulatory documents for new trials, ensure compliance with Institutional Review Boards (IRB), FDA, and sponsor regulations. Attend training sessions for new trials as necessary.
Data Management & Entry:
Collect and enter source data into CTMS and Electronic Data Capture (EDC) systems. Respond to data queries from monitors and work with them to resolve any issues.
Staff Training & Support:
Assist in the training of new personnel in Massachusetts to help manage the clinical trials and ensure compliance with protocols.
Template Development & eSource Management:
Support the creation of electronic templates in CTMS for new trials and assist in the development of eSource systems.
Travel Requirements:
Regular travel to TVCG offices to assist with trial start-up activities and patient enrollment.
Education:
Bachelor’s Degree in Biological Sciences, Health Sciences, Social Sciences, or a related medical field, or an equivalent combination of education and experience.
Experience:
At least 1 year of clinical research experience is preferred. Clinical experience in a surgical specialty, particularly in vascular research, is highly preferred.
Skills & Knowledge:
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