Note: The job is a remote job and is open to candidates in USA. Elite Clinical Network is focused on clinical research, and they are seeking a Clinical Research Source/CTMS Specialist. This role is responsible for the development and integration of clinical research source documentation, ensuring compliance and operational efficiencies across the research network.
Responsibilities
- Source Development: Design and build standardized source document templates that align with the protocol requirements and CTMS data fields
- System Integration: Ensure that as CTMS templates are built, corresponding source documents are simultaneously developed to prevent data silos or compliance gaps
- Quality & Compliance: Directly address and mitigate audit findings related to source management by implementing network-wide standards
- Site Support: Act as primary point of contact for sites regarding source management issues and technical troubleshooting across the network
- Collaboration: Work closely with the CTMS team and Clinical Operations to ensure all templates reflect the most current regulatory and study-specific requirements
Skills
- 3-5 years in clinical research, specifically focused on CTMS administration, data management, or clinical site monitoring
- Proficiency in CTMS platforms and electronic source (eSource) software
- Deep understanding of GCP, ICH guidelines, and FDA requirements regarding source documentation and ALCOA+ principles
- Proven ability to translate complex clinical protocols into user-friendly, compliant site documentation
- CCRC, CRA, CP, or similar preferred but not required
Company Overview
Elite Clinical Network operates pharmaceutical research sites and provides physician specialties as well as a candidate database. It was founded in 1996, and is headquartered in Las Vegas, Nevada, USA, with a workforce of 201-500 employees. Its website is https://eliteclinicalnetwork.com/.