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Clinical Research Coordinator
1 month ago
Plexus Partners is collaborating with a pioneering cardiology device start-up to support a pivotal global trial.
We are seeking a detail-oriented Clinical Trial Coordinator to manage and coordinate clinical trials, ensuring compliance with regulatory guidelines and study protocols. As a CTC, you will work closely with clinical teams, patients, and sponsors to facilitate the successful execution of clinical research projects.
Key Responsibilities:- Manage daily operations of clinical trials, including patient recruitment, screening, and enrollment.
- Obtain informed consent, ensuring participants understand the study.
- Handle documentation, including data entry, case reports, and regulatory files.
- Collaborate with investigators, research teams, and sponsors to follow protocols and timelines.
- Ensure compliance with FDA, IRB, and GCP guidelines.
- Prepare and submit IRB applications and amendments for timely approval.
- Schedule patient visits and collect data for study outcomes.
- Monitor patient safety and report any adverse events.
- Assist with audits, site visits, and inspections.
- Communicate effectively with participants, investigators, and clinical staff.
- Some clinical research experience (junior level role).
- Exposure to IDE trials and cardiovascular devices would be beneficial.
- Contribute to bringing life-saving technology to market.
- Work with a technology and company that has a strong reputation with physicians.
- Collaborate with a highly credible leadership team renowned in the space.
- Join a transparent, collaborative, and reputable team.
- Enjoy a hands-on role in a fast-moving start-up environment.
- Benefit from a relatively flat structure with minimal bureaucracy.
- Receive a highly attractive package based on experience.
- Minimal travel is required, with the role being full-time on-site in Minneapolis.