Senior Clinical Trial Associate

We are seeking a Sr. Clinical Trial Associate (Sr. CTA) role, who will support 1-3 project teams. In this role you will manage multiple administrative aspects of clinical trials across all project stages, including study start-up, enrollment, study conduct and close-out.  This may include creation of study documents, implementing and maintaining trackers, coordinating vendor payments and supplies to research units, performing quality control of clinical trial documents and assisting with study start-up contracting and study coordination activities. This role will also have accountability for managing the collection, review, completeness, and quality of their assigned eTMFs.

Key Responsibilities

• Act as a central contact for thecross-functionalstudyteam for designated project communications, correspondence, and associated documentation
• Maintainand perform QC reviews onstudy specific electronic Trial Master Filesto ensure inspection readiness and compliance with applicable regulations and Good Clinical Practices
• Track and report study metrics; inclusive of start-up, data management, and contracting as needed
• Participate inGxPaudits and related clinical compliance activities
• Prepare and track study documents (e.g., contracts, budgets, IRB documentation)
• Maintain databases/spreadsheets, as necessary, to facilitate tracking/documentation of departmental activities (e.g., CRFs, queries, and clinical data or sample flow, etc.)and assist in ensuring all systems, including but not limited to, EDC (Data Management), eTMF, CTMS, Payments, etc. are best utilized per Quality standards
• Administer user access and change control within Apogee’s electronic systems
• Assistin User Acceptance Testing for all EDC needsin regard toData Management and all Clinical Systems
• Assistwith vendor management and associatedlogistics, as assigned
• Contribute to the creation of presentations, as needed for project, departmental, sponsor and/or business development presentations
• Collaborate with Clinical Project Manager, Clinical SupplyUnitand QA in order to manage activities related to Clinical Supplies. Manage study related payment procedures. Interact with external providers during study conduct (CROs,monitorsand, occasionally, with investigators and Hospital personnel). May accompany CRAs on site visits toassistwith clinical monitoring duties upon completion of required training.
• Organize and/orparticipatein meetings with CROs. Ensureappropriate meetingminutes are prepared and filed in TMF
• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
• Assistin creating and implementing departmental proceduresAssist with information gathering, literature searches, and creation of presentations, as needed
• Responsible for managing team training assignments and oversight/ownership of due dates to support compliance

Ideal Candidate

• BS/BA in Life Sciences or equivalent
• 4+ years of experience in similar position in Biotech, Pharmaceutical or CRO industry and in R&D environment
• Extensive experiencewithTMF, including set-up, maintenance, QC/ QRand query management. Familiar with DIA reference model
• Knowledge of ICH/GCP and applicable regulations
• Demonstratedproficiencyin written, verbal and face-to-face communication to effectively present information to and influence decision making of managers, working partners (local and global)
• Ability to successfully manage multiple tasks and multifunctional resources concurrently whilemaintaininghigh attention to detail and responding to rapidly changing priorities and aggressive deadlines
• Proficient in MS Office (Word, Excel, Project), Adobe, SmartSheet, and ISI Toolbox
• Strong critical thinking, organizational and time-management skills
• SuccessfullyexhibitApogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Positionrequiresup to 15-20% travel,including mandatoryin-personattendance at Apogee All Hands meetings typically held twice per year.Travel is alsorequiredto attend key Phase 3 meetings,typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences.

The anticipated salary range for candidates for this role will be $130,000 - $145,000 per year.The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.