Note: The job is a remote job and is open to candidates in USA. Medasource is seeking a Clinical Research Associate to support a Traumatic Brain Injury clinical research initiative. This role involves overseeing multi-site clinical trial operations while ensuring compliance with protocols in a regulated environment.
Responsibilities
- Perform site qualification, initiation, interim monitoring, and close-out visits across assigned clinical sites
- Support oversight of approximately 4-5 clinical research sites, including primary and secondary site responsibilities
- Ensure protocol compliance, GCP adherence, and accurate study documentation
- Conduct source data verification/review and investigational product accountability activities
- Identify, document, and escalate site issues, deviations, and risks appropriately
- Complete detailed trip reports, monitoring documentation, and required reporting within established timelines
- Collaborate cross-functionally with clinical operations, investigators, and study coordinators
- Support multiple studies simultaneously as needed
- Maintain compliance with time tracking, reporting, and data handling procedures
Skills
- Strong monitoring fundamentals
- Exceptional attention to detail
- Ability to operate independently across multiple sites and stakeholders
- Perform site qualification, initiation, interim monitoring, and close-out visits across assigned clinical sites
- Support oversight of approximately 4-5 clinical research sites, including primary and secondary site responsibilities
- Ensure protocol compliance, GCP adherence, and accurate study documentation
- Conduct source data verification/review and investigational product accountability activities
- Identify, document, and escalate site issues, deviations, and risks appropriately
- Complete detailed trip reports, monitoring documentation, and required reporting within established timelines
- Collaborate cross-functionally with clinical operations, investigators, and study coordinators
- Support multiple studies simultaneously as needed
- Maintain compliance with time tracking, reporting, and data handling procedures
- Strong understanding of site monitoring activities
- Strong understanding of source data verification/review
- Strong understanding of investigational product accountability
- Strong understanding of GCP and clinical trial documentation requirements
- Excellent written and verbal communication skills
- Strong critical thinking and situational problem-solving abilities
- Ability to work independently and manage competing priorities across multiple sites
- Highly organized with strong time management skills
- Ability to travel nationally up to 75% as required
- Comfortable operating within a 40-hour work week structure
- 3-5+ years of clinical research experience preferred
- CRA experience within sponsor environments
- Strong clinical research coordinator experience from hospital or academic settings
Benefits
- Remote with up to 75% travel
- 1 year contract (potential of extension)
- Ability to operate within a 40-hour work week structure
Company Overview