At Headlands Research, we are building the best clinical trial company in the world. We’re an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding participant outreach and participation. Founded in 2018, our company is in high growth mode; we operate 15 clinical trial sites in the US and Canada and have rapid expansion plans. You can read more about us at headlandsresearch.com.
This position will be based in Atlantis, FL and is a full-time position.
JEM Research, a Headlands Research site, is searching for an eSource Document Specialist. This person will be responsible for the oversight and management of electronic source (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.
- 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
- Develop template logs (AE, Deviation, etc.)
within the eSource environment that will enable consistent centralized
- 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