[Remote] Clinical Research Source/CTMS Specialist
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.ResponsibilitiesSource Development: Design and build standardized source document templates that align with the protocol requirements and CTMS data fieldsSystem Integration: Ensure that as CTMS templates are built, corresponding source documents are simultaneously developed to prevent data silos or compliance gapsQuality & Compliance: Directly address and mitigate audit findings related to source management by implementing network-wide standardsSite Support: Act as primary point of contact for sites regarding source management issues and technical troubleshooting across the networkCollaboration: Work closely with the CTMS team and Clinical Operations to ensure all templates reflect the most current regulatory and study-specific requirementsSkills3-5 years in clinical research, specifically focused on CTMS administration, data management, or clinical site monitoringProficiency in CTMS platforms and electronic source (eSource) softwareDeep understanding of GCP, ICH guidelines, and FDA requirements regarding source documentation and ALCOA+ principlesProven ability to translate complex clinical protocols into user-friendly, compliant site documentationCCRC, CRA, CP, or similar preferred but not requiredCompany OverviewElite 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/.