Clinical Research Associate
We are partnered with an innovative medical device business specialising in structural heart solutions.
They are looking to hire a permanent CRA on the East Coast to manage daily site activities, for this first in class product.
TAVR / TAVI, CRO management and class III device experience needed! Preference for qualified candidates based in the Boston or Minneapolis metro areas
The Clinical Research Associate (CRA) will oversee the day-to-day operations of investigational site activities in a global pivotal trial.
Key Responsibilities :
- Supervise vendor activities or directly participate in study start-up and conduct, including drafting the ICF study-specific template and TMF plan, approving the study-specific essential documents list, and managing and communicating study progress.
- Lead the investigation of discrepancies in study documentation by applying clinical protocol knowledge and GCP, and develop processes to prevent reoccurrence throughout the study phases.
- Review documentation required for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents comply with Good Documentation Practices, internal SOPs, and US and international regulations.
- Conduct site initiation and monitoring visits, train site personnel and vendors on sponsor and regulatory requirements for study conduct, and participate in site meetings while preparing site initiation visit reports and associated documentation.
- Assess all data documentation, reports, records, transcripts, and exam results for consistency with case report forms and monitor clinical trial / study safety in accordance with protocols, GCP (Good Clinical Practices), PHI (Personal Health Information), and regulatory requirements.
- Verify trial / study data, maintain appropriate regulatory documents both internally and externally, and audit to ensure the site and vendors have the necessary regulatory documentation to conduct the trial / study, ensuring that source documentation is properly recorded.
Skills, Knowledge, Experience, and Qualifications :
- Bachelor's degree in a related field with over 5 years of field monitoring experience required.
- Experience with Class III cardiovascular devices.
- Experience with site- and sponsor-level FDA BIMO investigations.
- Experience working with CROs, core labs, and other external vendors.
- Proficiency in MS Office suite, including Word, Excel, PowerPoint, and Adobe.
- Experience in the medical device or regulated industry preferred.
- Clinical research certification (ACRP or SOCRA, Clinical Coordinator / CRA certification) preferred.
- Ability to travel up to 50% across the US and Canada.
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