US-MA-Bedford: Clinical Research Associate in biotech

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Date: 28-Apr-2009

Clinical Research Associate in biotech

* Support of the Clinical Affairs Director in protocol development *

Responsible for the development of the study Monitoring Plan * Works collaboratively with the Clinical Affairs Manager to execute investigator contracts in accordance with the departmental budget * Initiates, monitors and conducts Study Close Out procedures at clinical study centers; inclusive of training of study site personnel, oversight or protocol adherence, data verification of source documents and accountability of investigational study supplies. Must be able to troubleshoot and resolve routine study conduct issues * * Prepares project status and study reports. * Prompt reporting and follow through of regulatory deviations and adverse event reporting * Responsible for the management of clinical study supplies * Responsible for the preparation and maintenance of study master files * Responsible for study enrollment tracking and reporting at individual study centers * Coordinates all data entry activities with data management team including data clarification processing, review, and verification of investigator clarification responses * Assists with writing the clinical data sections of regulatory submissions

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

* Must have excellent computer skills including word processing, and database management * Excellent communications skills * BS degree in Science/Health discipline * Two years experience with clinical trials, either in industry or academic setting * Familiarity with medical research practices

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BioTech FYI Center
http://biotech.fyicenter.com/