Interesting opportunity with a growing, commercial stage company that has developed FDA approved systems that significantly improve treatment of atrial fibrillation. Work as a key Clinical Affairs team member in a collaborative, cross functional environment, and manage the execution of Phase II – IV cardiovascular device trials. Monitoring is mostly remote, with modest domestic travel.
- Provide overall clinical site management from qualification and start-up to closeout.
- Serve as liaison between sponsor, site Investigators, and Study Coordinators regarding protocol questions, queries, and enrollment.
- Responsible for site communication and instruction on clinical processes.
- Maintain audit-ready Trial Master File via regulatory document collection, review, and tracking.
- Conduct on-site/remote Site Initiation Visits, Interim Monitoring Visits and Closeout Visits according to Monitoring Plan and Data Management Plan. Activities include source document verification, electronic/paper CRF review, protocol and regulatory compliance, device accountability, and visit report writing.
- Complete study and clinical site status reports; provide ongoing status updates to management.
- Develop clinical trial documents and materials.
- Ensure that clinical trial is conducted in compliance with study protocol, SOP’s, FDA guidelines, GCP Guidelines, and ISO standards (as applicable).
- Facilitate clinical site contract and budget process.
- Collaborate with Regulatory Affairs on FDA and international regulatory submissions.
- Work closely with clinical project and commercial teams, external vendors (e.g., data management CRO, core lab).
- Conduct internal audits.
- Process and track site payments per approved budget.
- Verify proper device shipment, accountability and disposition.
- BS or greater in biology, health, medical or clinical sciences (e.g., Physiology or Nursing).
- 5-10 year’s medical device clinical research experience in an operating company or CRO setting.
- Clinical monitoring experience, including independent monitoring of medical device trials.
- Previous experience in a Phase II or III clinical trial, with cardiovascular experience preferred.
- Thorough understanding of Good Clinical Practices, ICH and FDA guidelines for clinical trials.
- Experience with Electronic Data Capture (EDC) systems.
- Solid computer skills (Microsoft Word, Outlook, Excel and PowerPoint).
- Ability to work on multiple projects in fast paced, dynamic environment.
- Excellent interpersonal, organizational, and critical thinking skills.
- Strong written, verbal, and presentation skills.
- Positive, self-motivated, creative, detailed, and solutions-oriented with the ability to work independently as well as collaboratively in a team environment.
- Travel: currently 10-20%.