Regional Contract Clinical Research Associates (Device)
Reference number: 1052
Location: Northeast and Canada - Northeast and Canada - - US, Canada
Job Type: Contract - Part-time
Category: Clinical Development
Salary: Based on experience
Our sponsor, a leading orthopaedic device company, is seeking a regional Clinical Research Associate to cover assigned regional sites in the northeast and Canada. This is a home-based part-time position conducting site visits as assigned by the Sponsor.
The CRA will be responsible for monitoring investigational sites according to sponsor SOPs and GCP/ICH guidelines. They will participate in the design and monitoring of clinical trials, analyze and evaluate clinical data, and ensure compliance with protocol and overall clinical objectives.
- Provide support to Project Team and assume additional roles on the team when possible
- Provide input into study documentation and monitoring worksheets
- Maintain working knowledge of protocols for assigned projects
- Serve as primary contact for assigned sites and maintain close contact with them throughout the study
- Schedule and conduct pre-study visits, initiation visits, interim monitoring visits and close-out visits
- Ensure that sites follow protocol requirements and applicable regulations
- Collect and ensure completeness of all essential regulatory documentation from sites from study start-up through close-out
- Review case report forms for completeness, accuracy, and legibility and perform source document verification
- Work with data management and sites to ensure all data queries are resolved
- Perform study device accountability during routine monitoring visits
- Ensure that sites are following AE/SAE reporting procedures per regulatory and study-specific requirements
- Complete all monitoring reports and follow-up letters in a timely manner
- Attend study team teleconferences/meetings, as needed
- Attend investigator meetings and provide support, as needed
- Make recommendations for improvement in processes to Project Manager/Director
Position requires a BS degree with at least 5 years of monitoring experience of complex clinical trials. Orthopaedic device trial experience (surgical implants) desirable.
Candidate must be fluent in French and English.
Must have knowledge of FDA regulatory requirements, GCP/ICH guidelines, and general medical terminology.