The eSource Specialist is responsible for the creation and management of the electronic source (eSource) system. This position will require making sure all team members are trained in eSource development and be the point of contact for anything eSource related.
The eSource Specialist must follow all Good Clinical Practice (GDP) guidelines during creation and maintenance of eSource structure.
Responsibilities may include but are not limited to:
- Create eSource shells for new studies according to protocol specifications
- Distribute eSource shell to the applicable teams and collaborate with staff to ensure specific eSource requirements are implemented
- Serve as a subject matter expert for eSource creation and mentor clinical site
- Develop template logs (AE, Deviation, etc.) within the eSource environment that will enable consistent centralized reporting
- Bachelor’s degree preferred
- 3+ years of clinical research experience (CRC, QA, Source, CRA)
- 3+ years of ICH/GCP guidelines and FDA regulations knowledge from hands-on work experience
- Familiar with medical terminology
- Able to build effective working relationships and collaborate within the organization
- Exercise excellent verbal and written communication skills