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Sr. Clinical Research Associate
· Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.
· Conducts periodic site file audits to ensure compliance with GCPs and Novella standard operating procedures.
· Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.
· Assists with, attends, and may present at Investigator Meetings for assigned studies.
· Performs study close-out visits.
· Authorized to request site audits for reasons of validity.
· Performs other duties as requested.
· Strong knowledge of clinical research process and medical terminology.
· At least four years experience in monitoring clinical trials preferred.
· Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
· Excellent organizational and interpersonal skills.
· Ability to interact with all levels of staff to coordinate/execute study activities.
· Ability to handle several priorities within multiple, complex clinical trials.
· Ability to reason independently and recommend specific solutions in clinical settings.
· Understanding of basic data processing functions, including electronic data capture.
· Understanding of current GCP/ICH guidelines applicable to the conduct of clinical research.
· Willingness and ability to travel domestically and internationally, as required.
· BS/BA (or equivalent) in one of the life sciences with a minimum of 4 years of monitoring experience or equivalent amount of education/experience.
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