eSource Architect Job at Headlands Horizons
The Company
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 14 clinical trial sites in the US and Canada and have rapid expansion plans.
This new clinical research eSource Architect role will be fully remote and can be based anywhere in the U.S. This is a full-time position.
You can read more about us at headlandsresearch.com.
The Role
The eSource architect at Headlands Research will be responsible for the oversight and management of eSource creation. 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.
TASKS
- Create eSource for new studies according to protocol specifications
- Distribute eSource 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 reporting
- Communicate with other teams (Finance, QA, Sites, etc.) to ensure eSource is fulfilling all requirements
- Other duties as assigned
EDUCATION & EXPERIENCE
- BA/BS degree preferred
- 2+ years of clinical research experience (CRC, QA, Source, CRA)
- 2+ years of ICH/GCP guidelines and FDA regulations knowledge from hands-on work experience
QUALIFICATIONS
- 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
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