Early Clinical Development Monitor
: Job Details :

Clinical Trial Quality * 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 Site Management * 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

Communication * Writes and submits timely and accurate monitoring visit reports, and study correspondence Compliance with Parexel standards * Complies with timely completion of required training curriculum * Completes timesheets accurately as required * Submits expense reports as required * Updates CV as required * Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: * 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 Knowledge and Experience: * Minimum of 5 years relevant industry experience Education: * Bachelor's Degree or equivalent is required