Clinical Safety Coordinator
Medpace is a global, full-service Clinical Research Organization (CRO) specializing in a multitude of therapeutic areas. Our headquarters are located in Cincinnati, Ohio, USA and we are active in over 45 countries across the globe. We continue to steadily grow and are looking to add to our team! Our European activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Safety Coordinator to join our UK team and to be based at our growing Scotland, Stirling office. This position will work in a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Duties of Clinical Safety Coordinator (CSC) would include: •Working closely with the Clinical Safety Manager to ensure each project deliverables are met; •Collect, process and track Serious Adverse Event (SAE) reports; •Generate study report narratives and CIOMS-I forms; •Daily interaction with investigative sites across Europe and Internationally; •Coordinate and prioritise daily project specific safety surveillance duties; •Oversight of submission of safety reports in the appropriate format to Competent Authorities/Ethics Committees in compliance with regulatory timelines; •Perform data entry of events into the EudraVigilance portal; •Regular interaction with other internal departments globally and locally, such as, Clinical Operations, Data Management and Regulatory Submissions; •Draft study specific safety documents as required; •Training and mentoring of other team members. This exciting role with Medpace offers a competitive salary and an opportunity for career progression. QUALIFICATIONS/REQUIREMENTS •Educated to degree level, Bachelor of Science; •Excellent time management skills with an ability to work to tight timelines; •An ability to interact well within a team environment, but also work independently and manage own workload; •Comprehensive understanding of Microsoft office suite; •Strong attention to detail; •Demonstrate fundamental knowledge of Good Clinical Practice (GCP) guidelines and medical terminology (preferred); •Knowledge of Electronic Data Capture (EDC) systems and other clinical databases (preferred); •Knowledge of applicable safety reporting EU guidelines (preferred). WHAT TO EXPECT NEXT We look forward to receiving your application. A member of our recruitment team will review your qualifications. If interested, you will be contacted for an interview.