Headlands Research is a leading globally integrated clinical trial site organization with the mission of dramatically improving the clinical trials process. Headlands is providing the highest level of clinical trial quality through significantly expanding trial participant outreach, enrollment of diverse populations, the integration of cutting-edge technology, high quality support services, and by having an exceptional platform of next generation sites.
The Clinical Data Coordinator at Headlands Research will be responsible for the oversight and management of eSource creation. The Coordinator will be converting master clinical trial protocol documents to electronic form. This will be done by working with EDC/eCRF guidelines, Lab Manuals & eDiary instructions. This position will serve as an internal resource that provides extensive training within the organization to ensure staff are trained and competent in all areas of eSource development.
Good Clinical Practice (GCP) requirements must always remain at the forefront of eSource design and general system architecture.
This position can be remote or based in one of the Headlands Research sites.
- Create eSource shells (convert clinical trial protocol documents to electronic form) for new studies according to protocol specifications
- Distribute eSource shell to the applicable sites and collaborate with local staff to ensure site specific eSource requirements are implemented
- Serve as a subject matter expert for eSource creation and mentor clinical sites
- Provide extensive training to new acquisitions
- Develop template logs (AE, Deviation, etc.) within the eSource environment that will enable consistent centralized reporting
- Other duties as assigned
EDUCATION & EXPERIENCE
- AS /BS degree preferred
- 4+ years of clinical research experience (CRC, QA, Source, CRA)
- 4+ years of ICH/GCP guidelines and FDA regulations knowledge from hands-on work experience
- Must be self-motivated
- Demonstrate the ability to think strategically and be the leader of change
- Familiar with medical terminology
- Exhibit proficiency in Microsoft Office (Word, Excel, PowerPoint, and Outlook)
- Able to build effective working relationships and collaborate within the organization
- Be a problem-solver, goal-oriented, and a team player
- Exercise excellent verbal and written communication skills