Clinical Research Coordinator

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

Requirements

• 80% in person work, 20% remote
• 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
• 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