Clinical Research Associate (CRA) - Cardiovascular Medical Device
New
M
MiRusMedical Devices
United States, Monday to Friday (8am – 5pm)Full-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- At least 2 years of experience in clinical research role, with at least 2 years in CRA role
- Required Skills
- GCP
Requirements
- Bachelor’s or Master’s degree in nursing.
- Clinical experience in the cardiac field (CCU, CVOR, Cath Lab).
- At least 2 years of experience in a clinical research role.
- At least 2 years of experience in a CRA role, preferably in cardiovascular medical devices.
- Proficiency in FDA regulations and ICH/GCP guidelines.
- Knowledge of medical device clinical trials design and best practices.
- General application of medical terminology (cardiovascular specific preferred).
- CRA certification is desired.
- Ability to travel domestically at least 20-40% of the time.
Responsibilities
- Contribute to content generation, writing and editing of study protocols, informed consents, committee charters, and study reports.
- Assist with the management of investigational studies from start through study closure.
- Engage in new study trial design with cross-functional teams.
- Assist with training investigators, study coordinators, and site personnel.
- Serve as the primary point of contact between clinical site investigators, CRO personnel, and the company team.
- Monitor ongoing compliance to study protocols in accordance with applicable regulations and GCP.
- Review source documentation to confirm subject eligibility for clinical trials.
- Manage clinical study documentation including the trial master file and tracking trackers.
- Provide continuous data review of source documents, case report forms, and data reports.
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