Covance Assoc Clin Res Coord in United States
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.
Serves as the primary point of contact for the PM and maintains close and proactive communication with the PM and the clinical team.
Provides 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 final approval of study schedules, study specific documentation, clinical set-up, resourcing and clinical conduct, delegating tasks as appropriate.
Monitors 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.
Other duties as assigned.
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).
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) orCPR/AED Certified Preferred :
Typically 2-3 years of professional work experience, must include clinical research or related experience.
Basic knowledge of computer and programs (e.g. Microsoft Word, Excel).
Knowledge of drug development process, ICH Guidelines and GCP.
Job Number 2019-27801
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