The Clinical Research Associate contributes to the success of clinical trials by conducting comprehensive monitoring activities throughout all study phases. Responsibilities include planning and executing site qualification, initiation, interim, and close-out visits to ensure adherence to protocols and regulatory requirements.
Key Responsibilities
- Oversee clinical trial operations by verifying proper handling, storage, and reconciliation of investigational products at study sites
- Train site staff on protocol specifics, therapeutic areas, documentation standards, and case report form procedures
- Ensure accurate and timely reporting of serious adverse events, protocol deviations, and laboratory anomalies
- Verify source data against case report forms to confirm completeness, consistency, and compliance
- Resolve data discrepancies through query management and direct coordination with investigative sites
- Maintain regulatory files and support site readiness for audits and inspections
- Manage shipment and tracking of investigational supplies and laboratory samples in accordance with protocol guidelines
- Produce detailed visit reports and maintain ongoing communication with investigators and study coordinators
Qualifications
Candidates must hold a bachelor’s or advanced degree in a life science discipline or equivalent experience. Strong attention to detail, organizational ability, and problem-solving skills are essential. Familiarity with FDA regulations, medical terminology, and pharmaceutical practices is required.
Proficiency in Microsoft Office applications—Word, Excel, and PowerPoint—is necessary. A valid driver’s license and reliable access to insured transportation are mandatory due to frequent travel. Prior CRA experience is preferred.
Work Environment
This position operates within a hybrid model, combining field-based monitoring with office or remote coordination. Regular travel, including short-notice domestic or international trips, is an expected component of the role.
Benefits & Culture
- Comprehensive medical, dental, and vision coverage for employees and dependents
- Flexible paid time off policy supporting personal and professional well-being
- 401(k) plan with company matching contributions
- Commitment to professional development and career advancement
- Inclusive, collaborative workplace culture focused on ethical research and global health impact
