Senior Clinical Research Associate - Early Development

October 8

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+

💰 Venture Round on 1990-01

Description

• Performs site management activities to ensure compliance to the protocol, monitoring plan, GCP, ICH, applicable federal/local regulations, and SOPs • Responsible for monitoring clinical trial quality and site management for client sponsored studies that are not fully outsourced to a contract research organization (CRO) • Conducts site qualification, initiation, interim, and close-out visits • Ensures sites meet performance expectations related to recruitment, enrollment, and retention • Reviews site source documentation, case reports, and verifies accurate data capture • Ensures site regulatory files are current, and verifies the timely submission of study documentation (including safety reporting) • Performs drug accountability, reconciliation, and destruction. Verifies storage and shipment requirements are according to protocol • Identifies and records protocol deviations • Maintains ongoing communications with site personnel and assists with problem solving during all stages of study start up, conduct, and close out • Builds and maintains professional relationships with site personnel • Analyzes issues and uses sound judgment to make decisions and escalates study related issues as necessary • Travels to clinical study sites as required, including remote or onsite visits globally

Requirements

• Minimum of 5 years relevant industry experience • Analytical problem-solving experience, trouble shooting and resourcefulness • Working knowledge of clinical drug development process • Effective communication, interpersonal skills, and the ability to build relationships • Familiarity with medical and clinical trial terminology • Proficient in written and spoken English required • Proficient in local language, as applicable, preferred • Proficiency in widely used technologies • Ability to learn client applications • Travel to be inclusive of regional, national and international as required