Clinical Research Associate (439195)
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POST DATE 9/12/2016
END DATE 10/9/2016
New York, NY
JOB DESCRIPTIONJob Description:
OVERVIEW: Work with the in-house clinical team to track and monitor day to day activities on Client s Phase 3 trials such as patient enrollment, data entry, protocol deviations, and other study matrixes. Interact with global clinical research organizations (CROs) and vendors to answer questions regarding study processes and procedures, as well as to monitor CRO activities. Participate in clinical data review as part of the database cleaning process, issue data queries, and confirm responses. Develop study documents such as informed consents, source documents, and meeting materials. Review of monitoring reports and flagging of issues for study manager. Review of study required regulatory documents and confirm sites meet all qualifications to enroll patients. Qualifications: 3 years Clinical Trial Associate, minimum, on one or more global clinical trials with at least some experience as an in-house clinical trial associate. Thorough understanding of ICH-GCP guidelines. Experience in on-site clinical trial monitoring a plus. University degree (equal to 4 years of college) in (para-) medical, pharmaceutical, sciences, life-sciences or biosciences. Equally recognized degree and/or relevant qualifications by experience may also be acceptable and will be evaluated on a case-by-case basis. The ability to handle multiple priorities within matrix environment is required. Must possess the ability to work independently, be flexible and have strong organizational skills. Good problem solving skills are desirable as well as ability to make suggestions to improve efficiencies. Fluent in English (written and spoken). Any other language is an asset. Good computer skills: Word, Excel, PowerPoint, Outlook. May require occasional travel.
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