US-MD-Gaithersburg: Clinical Trial Specialist

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Date: 03-Nov-2009

A minimum of 3 years of CRA or site coordinator experience in a pharmaceutical, biotech, diagnostic or research environment Associate, BA or BS, preferably in a legal or science field. Command of the spoken and written English language is required. Must be articulate and able to communicate effectively with employees at all levels of the organization on the telephone and in person and with key individuals outside the organization. These outside contacts include representatives from clinical sites Basic math skills are required. Demonstrated organizational, planning and prioritizing abilities are required. Thrive in a fast paced work environment, while possessing the ability to quickly change priorities and perform multiple tasks simultaneously. Demonstrates organizational skills and strong attention to detail; Ability to work under pressure to meet deadlines; Good verbal and written skills; Working knowledge of MS-Word, Excel and/or Access; Flexibility to adjust to changes in schedule, priorities, product availability;

Manage and provide support for multiple clinical sites ? Perform study site Interim and Close-out visits ? Write associated study site monitoring reports and site correspondence ? Monitor Case Report Forms ? Review informed consent forms ? Review and maintain regulatory documents at each site ? Order, track and verify supplies and study kits for each clinical site ? Track patient enrollment ? Track study site payments ? Ensure site follows GCP guidelines Review and Maintain in-house clinical study binders (Internal and External) Responsible for study site initiation and training Clinical data entry Clinical database auditing

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Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/