Period 04/28/2025 to 04/27/2026
Job Title: Senior Clinical Research Associate
Primary Function
Support pre-market and post-market clinical studies for regulatory compliance. Execute studies with minimal supervision in accordance with ISO 14155, 21 CFR Part 812, 50, 54, and other applicable regulations. Collaborate with study managers, CTAs, data management, and biostatistics. Review and summarize clinical literature and contribute to clinical reports and publications.
Essential Duties
Contribute to the execution and management of clinical studies.
Maintain study data and monitor study status.
Manage site start-up and activation processes: draft protocols, CRFs/eCRFs, ICFs, checklists, and assist with trial agreements and budgets.
Organize IRB/EC submissions and regulatory documentation.
Amend clinical study documents as needed.
Conduct site qualification, initiation, interim monitoring, and close-out visits.
Verify source data in EDC systems for protocol and regulatory compliance.
Act as main liaison with clinical trial sites; oversee data entry, query resolution, and device accountability.
Assist with data cleaning and safety event reviews.
Maintain trial master file and clinical trial management systems.
Manage site payments and financial tracking.
Support study design and surgeon/site selection.
Assist in site audits and preparation for inspections.
Mentor junior CRAs and CTAs.
Required Experience and Skills
Experience in medical device clinical trials.
Strong knowledge of ISO 14155, 21 CFR Part 11, 50, 54, 812.
Familiarity with ICH/GCP and clinical monitoring requirements.
Experience with protocol/ICF development and regulatory writing.
Contract and budget negotiation experience.
Proficiency in Microsoft Office, PDF software, and EDC systems.
Experience in medical device industry.
Clinical research/clinical trial management certification preferred.
Experience with clinical trial management systems preferred.
Willingness to travel 25–40%.
Education and Training
BA/BS and 8+ years of experience, or Nursing degree and 6+ years, or Master’s/MD/PhD and 3+ years in a scientific field.
Preferred
Experience in hospital environments with nurses and surgeons.
Knowledge of statistics and experimental design.