Vascular Breakthroughs manages clinical trials for a growing group of vascular surgeons. Trials managed include device and drug trials. The trials range from being first in main pilot studies, IDE trials to post-market registry trials.
We utilize a robust clinical trial management system that enables us to store all subject binders and regulatory binders electronically greatly facilitating remote management of trials and regulatory compliance.
This 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.
- 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
- Bachelor’s Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required
- Clinical experience in a surgical specialty field required; vascular preferred
- One year of experience in a clinical research capacity or knowledge in clinical research preferred
- 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