Backed by 5AM Ventures.
About the role
Latigo is seeking a highly organized and detailed oriented Clinical Trial Associate to provide operational and administrative support for Latigo-sponsored clinical trials. This position will support the Clinical Operations team across study start-up, maintenance, and close-out activities, including study document tracking, Trial Master File support, meeting coordination, vendor and site communication, and study systems support.
What they're looking for
- Organize and maintain the internal study Sharepoint site for assigned studies
- Maintain study trackers, contact lists, meeting action item logs, training trackers, vendor trackers, and other study management tools to support accurate and timely study oversight
- Schedule study meetings, prepare agendas, draft meeting minutes, distribute follow-up items, and track action items through resolution, as assigned
- Support clinical trial systems and portals, including access requests, user tracking, document uploads, and follow-up on system-related issues as appropriate
- Assist with review and reconciliation of study documents, site correspondence, monitoring documentation, safety-related documentation, and vendor deliverables, as assigned
- Coordinate logistics for investigator meetings, study team meetings, site training, vendor meetings, and other clinical trial activities, as required
More about this role
Latigo is seeking a highly organized and detailed oriented Clinical Trial Associate to provide operational and administrative support for Latigo-sponsored clinical trials. This position will support the Clinical Operations team across study start-up, maintenance, and close-out activities, including study document tracking, Trial Master File support, meeting coordination, vendor and site communication, and study systems support. The successful candidate will work closely with the clinical trial leads and cross-functional team members, vendors, and trial sites to help ensure clinical trials are conducted in accordance with study protocols, applicable SOPs and study plans, ICH-GCP, and regulatory requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Assist with study start-up activities, including eTMF index/structure review and other eTMF set-up activities, collection and tracking of essential documents, site contact information, regulatory documents, training documentation, and review of study-specific materials.
- Oversee the maintenance of the electronic Trial Master File (eTMF) for all assigned studies, in accordance with applicable study plans, and SOPs. Ensure timely and...
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