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