Clinical Operations Associate

Clinical Research CoordinatorResponsibilities:Contribute to the development of study-related documents (Clinical protocols, ICFs, IBs, monitoring plans, study manuals, etc.)Partner with Investigators and clinical site staff to ensure optimal Sponsor-Site relationshipsReview study-specific essential regulatory document packets prior to site activationsParticipate in the ongoing review and cleaning of clinical trial dataAssist with the management of tracking, logistics, and quality operations for biological samples to help ensure that sample inventories are accurate and up to dateAttend and provide support in meeting scheduling and distribution of meeting agendas/minutesReview monitoring reports and protocol deviations to help track issues and data trends at sitesAssist with IMP tracking to verify adequate supply at sites and depotsIn conjunction with the CRO, manage submission of documents to and maintenance of the TMF, to ensure continual inspection-readinessSupport study finance and contract processes for 3rd party vendors (invoice tracking, approval, and accruals)Effectively communicate trial details to ensure that all team members are kept informedParticipate in SOP development and process improvement projects (as necessary)Qualifications:BA/BS degree required with a minimum of 2 years relevant clinical research experience working at an Investigator Site, Sponsor, or Clinical Research OrganizationWorking knowledge of ICH/GCP guidelines and FDA regulationsAbility to collaborate effectively with cross-functional team members and external partnersStrong organizational and time management skills, including the capacity to work independently and prioritize multiple projectsExperience working with eTMFs strongly preferred