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.
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
Compensation
$60,000 - $70,000 per year. Negotiable dependent on skills and experience