The Clinical Research Coordinator will have the overall responsibility for the operational conduct of assigned studies, in close relationship with the Project Manager, Principal Investigator and operational staff. The CRC will ensure that all studies are conducted in accordance with Federal, state and protocol requirements, standard operating procedures, Good Clinical Practice (GCP), and Covance standards of Good Laboratory Practice (GLP) as appropriate. The Clinical Research Coordinator is the primary site contact for the Project Manager (PM) and will ensure that client requirements are met as well the safety and integrity of the study participants is maintained.
A. Duties and Responsibilities:
- Serve as site lead for all assigned Phase I clinical studies ensuring that studies are delivered according to Sponsor requirements on time and to high quality.
- Serve as the primary point of contact for the PM and maintains close and proactive communication with the PM and the clinical team.
- Provide consolidated comments from the clinical site on the draft study protocol to the Project Manager, taking into account operational and subject safety issues. Distributes protocols and amendments to the site staff.
- Perform all aspects of the clinical process to include the development and approval of study schedules, study specific documentation, clinical set-up, resourcing and clinical conduct, delegating tasks as appropriate.
- Monitor and maintains participant safety, dignity and compliance, including coordination of appropriate medical consultation/treatment as appropriate. Provides updates regarding participants well being to the investigators and PM including AE updates etc.
- Work closely and proactively with operational teams to ensure that the laboratory, equipment and all operational requirements are fulfilled, study is adequately resourced and all personnel are trained and competent on all study procedures.
- Keep the PM and site management aware of deficiencies or potential problems and assists in taking appropriate action in response to these issues.
- Support the training of staff on project-specific and standardized Clinical Operations processes.
- Is aware of client expectations for trial conduct and works to meet or exceed them.
- Ensure that all studies are carried out in strict accordance with the relevant protocols, SOPs and the specified standard of the GCPs. Make operational decisions with guidance ensuring that data quality remains high.
- Facilitate and coordinate client visits, with assistance of the PM and/or site management where appropriate.
- Engage in communication with PM to obtain background information regarding the client and the study. Facilitates the coordination of clinical timelines and activities with guidance.
- Is fully aware of all regulatory submissions, timelines and approvals.
- Coordinate and ensure submission of documents to the IRB/IEC as appropriate for timely review.
- Review and apply operational knowledge to the conduct of a protocol and participates in client protocol discussions with senior staff oversight.
- University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
o In lieu of a degree, typically 3 years experience in related field (e.g. pharmaceutical, laboratory, data analysis) will be considered in addition to the experience requirement.
- Basic Life Support Skills (BLS) or CPR/AED Certified
Experience - Typically 1-2 years of professional work experience, must include clinical research or related experience.
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