Clinical Research Nurse

About the role

Vascular Breakthroughs manages clinical trials for a growing group of vascular surgeons, including device and drug trials ranging from first-in-human pilot studies and IDE trials to post-market registry trials. We use a robust clinical trial management system that stores all subject and regulatory binders electronically, facilitating remote management and regulatory compliance.

This role supports clinical trial start-up activities and coordinates patient enrollment across The Vascular Care Group (“TVCG”). Willingness to drive between TVCG sites is required; primary work locations are Wellesley, Plymouth, and Hyannis, with additional sites as needed. The role is 80% in-person and 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 eligible participants for 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 complications, and provide care
• Assist with device accountability, including transport or shipping of devices to practice sites as needed
• Assist with gathering required regulatory documents for new trials and attend training sessions
• Assist with collecting source data to enter into CTMS, input data into EDC systems, respond to queries, and work with monitors to resolve them
• Assist with adding and training additional personnel in Massachusetts to be delegated to work on clinical trials
• Support activities to ensure compliance with all Institutional Review Boards (IRB), FDA, federal, state, and industry sponsor regulations
• Assist in building electronic templates into CTMS for new trials to create eSource
• Travel regularly to TVCG offices to assist in trial start-up and enrollment activities

Requirements

• Minimum of ADN/LPN; BSN preferred
• 3-5 years of experience in a clinical research capacity or knowledge of clinical research
• Clinical experience in a surgical specialty field required; vascular preferred
• Patient-facing experience preferred
• Knowledge of medical terminology required
• Computer skills required, including proficiency with Electronic Medical Records and Electronic Data Capture systems
• Must be detail-oriented, facile with computer systems, able to work independently, and willing to take on challenges