Sr. Clinical Research Associate (Cardiac Catheter Products)
New
J
JobgetherMedical technology
Remote work opportunity within the United States.Full-TimeSenior
Salary not disclosed
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Job Details
- Experience
- At least 5 years of experience directly supporting clinical research or working in a relevant medical or scientific field; at least 3 years of Clinical Research Associate experience supporting medical device or biotechnology clinical trials.
Requirements
- Bachelor’s degree or equivalent combination of education and experience.
- Minimum 5 years of experience in clinical research or relevant medical/scientific fields.
- Minimum 3 years of Clinical Research Associate experience with medical devices or biotechnology.
- Strong knowledge of ICH-GCP, FDA regulations, SOPs, and local clinical research requirements.
- Proficiency with EDC and CTMS platforms.
- Strong proficiency with Adobe Acrobat, Microsoft Word, Excel, PowerPoint, and Smartsheet.
- Ability to travel approximately 30%–50% of the time.
- Ability to lift approximately 10–15 pounds.
- Strong critical-thinking, analytical, and problem-solving abilities.
- Cardiovascular device or cardiac clinical research experience preferred.
- CRA certification (e.g., CCRA, CCRP) preferred.
Responsibilities
- Manage and monitor clinical research activities across U.S. and international clinical sites.
- Provide clinical case support and coordinate site activities throughout the study lifecycle.
- Review case report forms, source documentation, and study records to ensure data quality and protocol adherence.
- Prepare study documentation, including informed consent forms, monitoring reports, and regulatory submissions.
- Track and resolve missing action items, data queries, and protocol deviations.
- Manage investigational product accountability and report adverse events.
- Coach and mentor other Clinical Research Associates.
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