Upvote
Downvote
Senior Clinical Research Associate
Share Job
- Suggest Revision
$100,000 - $135,000 a year
Full-time
- Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Clinical Research Associate.
- The Senior Clinical Research Associate should ensure compliance with international guidelines, local regulations and corporate policies and procedures.
- Coordinate study start-up and study conduct activities, including: drafting ICF study specific template and TMF plan, approving study-specific essential documents list, managing and communicating the status of study progress and activities
- Conduct reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Abiomed internal SOPs, and US and OUS regulations
- Assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices), PHI (Personal Health Information) and regulatory requirements.
Active Job
Updated 1 month agoSimilar Job
Relevance
Active