Senior Early Phase CRA - FSP

ExecuPharm (a Parexel Company) are currently looking for an experienced early phase Senior Clinical Research Associate to join our expanding team in Belgium, in this position you’ll be solely dedicated to one of our longest standing clients, a well known global biopharmaceutical company.

The Early Clinical Development (ECD) Monitor is a senior level Clinical Research Associate (CRA) with relevant Phase I experience, responsible for conducting monitoring activities for one or more client conducted studies.

Primary Duties:

Performs site management activities to ensure compliance to the protocol, monitoring plan, GCP, ICH, applicable federal/local regulations, and SOPs. Conducts site qualification, initiation, interim, and close-out visits. Ensures sites meet performance expectations related to recruitment, enrollment, and retention. Maintains ongoing communications with site personnel and assists with problem solving during study conduct; builds and maintains professional relationships with site personnel. Reviews site source documentation, case reports, and verifies accurate data capture. Performs drug accountability, reconciliation, and destructions. Verifies storage and shipment requirements are according to protocol. Ensures site regulatory files are current and verifies the timely submission of study documentation (including safety reporting). Identifies and records protocol deviations. Analyzes issues and uses sound judgment to make decisions; escalates study-related issues as necessary. Writes and submits timely and accurate monitoring visit reports, and study correspondence. Maintains ongoing communications with the study team and actively participates in team meetings. Participates and may lead process improvement initiatives for the department. Completes training assigned by Regeneron and/or EP, as necessary, including general training requirements, SOPs, system and process related training. Site management with travel to clinical study sites as required. QualificationsSkills:

Bachelor’s Degree is required. Minimum of 5 years relevant industry experience is required. Phase I clinical trial experience is preferred but we can consider phase II experience as well. Problem solving abilities, troubleshooting and resourcefulness. Working knowledge of clinical drug development process as well as ICH, GCP guidelines, and US FDA and/or local country regulations as applicable. Effective communication and interpersonal skills. The ability to build relationships internally and externally.