People come to Covance to make a difference in the world!
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.
Covance Inc., with headquarters in Princeton, NJ, is one of the world's largest and most comprehensive drug development services companies with 2003 revenues of $940 million, global operations, and 6,500 employees worldwide. Covance's purpose is to lead advancements in drug development through science, service, and shaping solutions.
We are seeking a Senior Clinical Research Associate- Site Management t in for a home-based position in Detroit MI.
Site administration and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP.
May act as Local Project Coordinator.
May manage small projects under direction of a Project Manager/Director, as assigned.
May serve as lead monitor for a protocol or project and may assist in establishing monitoring plans.
Review progress of projects and initiate appropriate actions to achieve target objectives.
Organize and make presentations at Investigator Meetings.
Report, write narratives and follow-up on serious adverse experiences.
May participate in the development of protocols and Case Report Forms.
May participate in writing clinical trial reports.
Interact with internal work groups to evaluate needs, resources and timelines.
May act as contact for clinical trial supplies and other suppliers (vendors).
Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
General On-Site Monitoring Responsibilities
Occasional Travel to investigator sites.
QUALIFICATIONS:
University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.
Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries. • Thorough understanding of the drug development process.
Fluent in local office language and in English, both written and verbal.
Thorough knowledge of Covance S.O.P.s regarding site monitoring.
Minimum of four (4) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits). In lieu of the above requirements, candidates with > five (5) years supervisory experience in a health care setting and three (3) years clinical research experience in the pharmaceutical or CRO industries (including monitoring) will be considered.
Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
One (1) or more year’s additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred. • Local project coordination and/or project management.
Covance is committed to diversity in the workplace and is an equal opportunity employer.
Please apply online at: www.covance.com/careers, indicating that you viewed this position on michiganjobnetwork.com
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