Role Summary
We are seeking a highly organized and proactive Clinical Operations professional to support the successful execution of our clinical trials. In this key role, you will partner closely with the Clinical Operations Study Lead to manage critical components of study delivery—ensuring timelines, quality standards, and budget expectations are met. You will drive meeting coordination, site and vendor support, documentation management, and quality oversight across assigned studies. This position offers the opportunity to make a meaningful impact on study execution while working with minimal oversight.Key ResponsibilitiesStudy Team & Meeting Management (50%)Lead preparation of agendas and meeting minutes for cross-functional study team meetingsSupport site start-up activitiesManage ancillary vendors as assignedParticipate in Investigator Meetings, including presenting materials when appropriateStudy Documentation, Tracking & Quality (50%)Monitor systems, processes, and vendors to ensure clinical trial data quality; identify risks and recommend improvementsReview clinical protocols for operational feasibility and anticipate potential study delivery challengesDraft and maintain clinical project timelines; proactively escalate risks to the Study LeadSupport clinical trial budget analysis and cost trackingTrack 1572s and collaborate with Regulatory for IND submissions and essential documentsMaintain and QC Trial Master File (TMF) documentsAssist with creation and distribution of ICF templates, manuals, and other study materialsContribute to the review of core study documents (protocol, IB, CSR)Manage sample accountability and trackingDevelop, maintain, and QC study documentation and trackersPerform additional operational activities as assigned
