The Clinical Research Specialist will play a key role in managing and advancing a clinical study focused on coronary structural heart devices. Working under the direction of the Study Manager, this position ensures adherence to regulatory standards while supporting critical study functions from initiation through long-term follow-up.
Key Responsibilities
- Monitor study progress, including participant enrollment, follow-up activities, site activation, and maintenance of the trial master file.
- Conduct audits of study documentation to verify regulatory compliance and completeness of site files.
- Track and reconcile medical device accountability across study locations.
- Review and analyze protocol deviations to support trending and reporting requirements.
- Generate regular status reports and document meeting minutes for internal and external stakeholders.
- Support the planning and coordination of investigator meetings, including preparation of materials.
- Provide timely updates to leadership on study milestones, challenges, and progress.
Qualifications
Candidates must hold a bachelor’s degree in a scientific discipline and have at least three years of experience in clinical research or a related medical field. Familiarity with Good Clinical Practice (GCP) and clinical trial regulations is essential. A master’s degree may reduce the required experience by one year; a PhD or MD may reduce it by two.
Strong written and verbal communication skills, including fluency in medical terminology, are required. Proficiency in MS Office, spreadsheets, and word processing tools is expected. The ideal candidate is detail-oriented, capable of managing multiple priorities, and skilled at problem-solving in a collaborative environment.
Previous experience in clinical trials, site management, or medical device studies is preferred. The individual must demonstrate professionalism, reliability, and the ability to work effectively within cross-functional teams.
