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This is a Boston, MA Hybrid role and requires 2-3 days in the office. Responsible for assisting with the planning and management of the operational aspects of clinical trials, including CRO and vendor management/oversight, ensuring project milestones and objectives are met and clinical study deliverables are consistent with program/company goals. Responsible for collecting, tracking, and reviewing investigator site regulatory documents for completion and accuracy, including FDFs, 1572s, CVs, medical licenses and other study specific documents as needed. Lead and drive TMF filing, management, oversight, & reconciliation activities, including interaction and coordination of all essential internal TMF contributing functions and the responsible CRO according to ICH-GCP, company SOPs and Wis. Responsible for recording minutes for vendor, study team and site teleconferences, distributing for team review and consolidating comments into one document prior to submitting for finalization and distribution to the study team. Responsible for tracking regulatory and other essential study documents, CTA/budget status, site and vendor payments, SUSARs (safety letter) and monitoring visits/reports. Ensure in conjunction with the Clinical Trial Leader (CTL) that study related systems (Kura and/or CRO) are updated on a regular basis. Assist study team in managing study start-up, conduct and close-out activities and other project related activities. Assist study team in the conduct of studies and ensure they are implemented according to the study protocols and in compliance with local, ICH, GCP and company policies and procedures. Assist study team to ensure clinical trials meet time, quality, and cost targets consistent with the overall Clinical Development Plan. Assist the CTLs/ Study Teams/ CST in preparation of Audits or Inspections and participate in Audit and Inspection interviews, as required. Assist with monitoring study sites as needed. Assist with ordering and tracking delivery and receipt of required study supplies and investigational product to study sites and provide regular status updates. Assist with organizing and managing project timelines and budgets; help ensure project deliverables are on time and within budget and amended; accordingly. Manage Purchase Orders, financial tracking, invoice processing, and other budgetary support in a timely manner and according set expectations. Set up contracts in Coupa as required and ensure all financial documentation is always Audit & Inspection ready. Assist with oversight and tracking receipt of laboratory samples to the laboratory vendor(s). Assist with oversight of operational activities from start-up to close-out to ensure deliverables are prioritized and goals and objectives are met and/or changed accordingly. Assist with the development and review of study-related documents, including clinical protocols, ICFs, CRFs, monitoring plans, study, laboratory and pharmacy manuals, data management plans, etc. Assist with the review and approval of study site and vendor payments. Assist with tracking enrollment status and providing updates to study team and vendors. Assist with tracking program study drug inventory to ensure adequate drug supply available to support ongoing/future studies. Collaborate with internal and external team members for the planning and execution of clinical trials. Review study reporting both internally and externally for quality and accuracy of any relevant details required. Support clinical trial insurance activities on assigned trials. Support CTLs in the surveillance of Kura company compliance in assigned studies/programs. Support Inspection Readiness activities for priority projects, as assigned, including coordination of study oversight activities. Contribute to workshops / special initiatives as expert/ professional for dedicated topics. Maintain Study Team Lists. Maintain SUSAR distribution lists and coordinate compliance reviews for assigned trials. Maintain knowledge and usage of databases and platforms used by the department. Prepare and hold presentations for training sessions, line managers meetings, department meetings, program or study meetings as required. Provide knowledge and assistance with the Kura Medical Review Committee (MRC) review of clinical trial materials according to the MRC charter. Complete other duties as assigned by the manager. Job specifications include ability to work in a matrix environment, experience working in a high-volume environment while maintaining organization and prioritization, good understanding of responsibilities and needs of other functions in a clinical trial, reliability, conscientiousness, confidentiality, strong interpersonal skills, some experience in oncology, preferred experience in CRO oversight, strong organization, documentation, and communication skills, ability to travel up to approximately 30%, and relevant educational and professional experience requirements. The role offers career advancement, competitive compensation, bonus, 401K with employer contributions, stock options, ESPP plan, PTO, holidays, benefits, paid parental leave, in-office catered lunches, home office setup, lifestyle and commuter stipends, and social activities. Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment.
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