Would you like to bring innovative solutions to life threatening cardiac abnormalities to the clinic, in a CRA position with little to no travel? You’d have that opportunity as a key member of a Clinical Affairs team in a collaborative and cross functional environment. The self-motivated individual in this role will have broad responsibility for managing and executing the current Phase IV cardiovascular trials now, and additional studies as the company continues to develop new products.
Responsibilities:
- Provide overall clinical site management from start-up to close-out.
- Serve as liaison between sponsor, site Investigators, and Study Coordinators for 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 remote site initiation, interim monitoring and close-out visits per Monitoring and Data Management Plans; activities include verification of source document, electronic CRF review, regulatory document review, and assessment of protocol and regulatory compliance.
- Complete clinical site status and monitoring reports; provide ongoing status updates to management.
- Facilitate clinical site contract and budget process.
- Develop clinical trial documents and materials.
- Collaborate with project team and data management CRO.
- Ensure that clinical trial is conducted in compliance with study protocol, SOP’s, FDA and GCP Guidelines.
Qualifications:
- BS or greater in biology, health, medical or clinical sciences (e.g., Physiology or Nursing).
- Five plus years clinical research monitoring experience in a medical device or device CRO setting. Previous cardiovascular clinical trial exposure is a plus.
- Thorough understanding of GCP, ICH and FDA guidelines for clinical trials.
- Experience with Electronic Data Capture (EDC) systems.
- Skilled using Microsoft Word, Outlook, Excel, and PowerPoint.
- Ability to work independently and collaboratively in a fast paced, dynamic setting.
- Strong written, verbal, and presentation skills.
- Positive, self-motivated, flexible, creative, detail and solutions-oriented attitude.