The Senior Clinical Research Associate performs all study monitoring visits and supports study start-up, conduct, and closeout activities while ensuring adherence to regulatory requirements and quality systems
Job Summary
The Senior Clinical Research Associate performs all study monitoring visits and supports study start-up, conduct, and closeout activities while ensuring adherence to regulatory requirements and quality systems.
This role includes responsibilities such as training site staff, maintaining study documentation, facilitating audits, and serving as the primary contact for assigned sites to resolve data queries and monitoring findings.
The position offers a full-time schedule with remote work options and a competitive salary range plus bonus, stock, and benefits, emphasizing an inclusive and equal opportunity workplace.
Matching Summary
The Senior Clinical Research Associate performs all study monitoring visits and supports study start-up, conduct, and closeout activities while ensuring adherence to regulatory requirements and quality systems.
Salary
Base: $80,800.00 - $151,500.00/yr; Bonus/Equity: eligibility for bonus, stock; Benefits: included
Skills & Requirements
Must-have
Study monitoring visits and reporting
Source Data Verification (SDV)
Electronic Data Capture (EDC) systems
Good Clinical Practice (GCP) adherence
Trial Master File (TMF) maintenance
Clinical research protocol training
Investigator site communication
Nice-to-have
Mentoring and training new CRA staff
Cross-functional project team collaboration
Risk identification and mitigation
Strong organizational and problem-solving skills
Diplomacy and facilitation skills
Key Requirements
Bachelor's degree in biological sciences or medical specialty
5+ years direct clinical research experience
Experience with molecular diagnostic and medical device studies
Knowledge of ICH/GCP guidelines and 21 CFR part 812
Proficient with Microsoft Office Suite
Experience with Next Generation Sequencing (NGS) and Immunohistochemistry (IHC)