As a member of the clinical research team, the Clinical Research Coordinator (CRC) participates in the overall organization and operational administration of clinical studies to assess the safety and effectiveness of Regenesis products. The CRC is responsible for coordinating and tracking the set up and day-to-day operations of investigative sites as they execute Regenesis protocols from study start up to study close.
ESSENTIAL DUTIES & RESPONSIBILITIES
- In coordination with the Clinical Research Team, work with investigative sites to ensure understanding and compliance to the protocol, ongoing regulatory compliance, and achievement of enrollment targets.
- Participate in preparing and delivering presentations of protocols and other study requirements at study initiation, including training at investigational sites.
- Assist in the start-up and close-out processes at investigative sites
- Manage distribution, collection, tracking and filing of regulatory documentation from the sites during study start-up, conduct and close of the clinical study.
- Manage supply and distribution of study materials including test device and other materials subject to accountability requirements.
- Coordinate the successful procurement of protocol specific subject specimens as needed.
- Data entry and tracking of enrollment, clinical trial reports, documents, and correspondence.
- Act as company liaison, working with clinical sites to resolve any site related issues and queries quickly and effectively.
- Assist with the development, review, and distribution of study-related documents including Case Report Forms (CRF's), study protocols, study manuals, and other study documents to investigational sites and review committees.
- Participate in clinical research site visits including qualification, initiation, routine monitoring, and final close out visits.
- Assist with the development, negotiation, and execution of the site contracts, budgets and payment plans.
- Coordinates clinical projects to assure they are conducted in compliance with the protocol, Regenesis Standard Operating Procedures, Good Clinical Practice and appropriate regulatory requirements.
- Maintains up to date extensive knowledge and understanding of Good Clinical Practice regulations, FDA guidance documents and industry trends/best practices.
- Other study related procedures and duties as assigned.