Senior Clinical Trial Associate

• 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, 1572's, 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

SR. CTA EXPECTATIONS:

• Highly experienced with using different eTMF systems (e.g., Veeva Vault, etc.)
• Accountable for projects within a clearly defined scope and milestones.
• Accountable for the quality of own work. Works independently and receives a moderate to low level of guidance or direction within clear or even broad guidelines.
• Ensure harmonization of processes throughout Clinical Operations, use best practices to improve products or services
• Contribute to mentoring, training and provision of direction and guidance to increase knowledge of new team members / new employees
• Make process improvement suggestions and develop new process approaches
• Demonstrate ownership for all assigned tasks and demonstrate a willingness to build knowledge
• Take on additional tasks as assigned by management
• Proficient in using and training other CTAs & CTLs on the financial tools / systems to create accurate financial documents
• Independently support CTLs/ Trial Teams for budget management & forecast as well as for building accruals upon request
• Close collaboration with CTA Line Manager to align on new concepts, address resource topics, exchange status updates
• Responsible for driving and guiding the respective group, while implementing efficient processes, data driven approaches, tools, and training
• Responsible to conduct and lead CTA trainings and meetings on request
• Responsible to monitor quality and compliance of CTA implemented processes
• Role Model and represent / present the CTA Team to Leadership as well as internal / external functions, if needed
• Drive/Coordinate/Track the follow-up of action items within the Corrective and Preventive Action Plans (CAPAs) associated with Audits and attending meetings, as requested

• Requires a bachelor's degree in scientific field plus some to substantial relevant professional experience, and good knowledge and experience in clinical trial management or a substantial amount of professional experience in a clinical research-related position (4 years or equivalent) and/ or additional qualifications that also provides exposure to fundamental clinical research related skills & knowledge
• Ability to mentor and coach junior or new staff
• Advanced knowledge of medical and trial related terminology
• Excellent administrative and coordination skills
• Excellent communication skills - both verbal and written
• Excellent computer skills including knowledge of MS Office (Excel, Word, PowerPoint), Outlook, and TEAMS
• Excellent oral and written communication in English
• Excellent time and priority management, ability to work efficiently under pressure
• Excellent understanding of the policies and procedures of Clinical Operations and of ICH-GCP and current FDA regulations.
• Highly motivated, shows initiative, is proactive and able to work independently as well as in a team
• Professional Trial Master File experience, including use of different eTMF systems
• Strong organizational and problem-solving skills
• Willing to take on responsibility and accountability, exhibits Leadership skills