Senior Clinical Trial Associate

 

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.  If this sounds like you, keep reading!

 

Role Summary

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 the cross-functional study team for designated project communications, correspondence, and associated documentation
• Maintain and perform QC reviews on study specific electronic Trial Master Files to 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 in GxP audits 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
• Assist in User Acceptance Testing for all EDC needs in regard to Data Management and all Clinical Systems
• Assist with vendor management and associated logistics, 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 Supply Unit and QA in order to manage activities related to Clinical Supplies. Manage study related payment procedures. Interact with external providers during study conduct (CROs, monitors and, occasionally, with investigators and Hospital personnel). May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.  
• Organize and/or participate in meetings with CROs. Ensure appropriate meeting minutes are prepared and filed in TMF
• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
• Assist in creating and implementing departmental procedures Assist 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 experience with TMF, including set-up, maintenance, QC/ QR and query management. Familiar with DIA reference model
• Knowledge of ICH/GCP and applicable regulations
• Demonstrated proficiency in written, verbal and face-to-face communication to effectively present information to and influence decision making of ma