Manage day-to-day activities of clinical studies from initiation through close-out
Ensure compliance with applicable regulations, Good Clinical Practice, company standards and procedures
Plan and conduct monitoring activities and visits
Ensure data quality, participant protection of privacy, safety, and compliance with current regulations
Provide leadership and mentoring within the clinical research team
Handle site interactions, site training, regulatory document collection, enrollment tracking
Ensure accuracy, completeness, and verifiable documentation

BS in healthcare or science related discipline
5+ years’ experience as Clinical Research Associate directly involved with site monitoring
Preferably 2+ years of experience with medical devices and/or diagnostic studies
Professional certification through one or more relevant associations is desirable (e.g., ACRP, SOCRA, RAPS)
Working knowledge of ICH Good Clinical Practices
Strong working knowledge of Good Clinical Practices (GCP), local regulations, relevant ISO standards and current industry practices related to the conduct of clinical trials and applicable local and regional regulations
Previous experience with EDC, CTMS, and eTMF systems required

Senior Clinical Research Associate

Key skills