Senior Clinical Trial Associate at Cogent Biosciences in Waltham, MA

Job description

Who We Are: Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. Cogent’s lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V. KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib has exhibited promising initial data across all three trials: APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing. The Role: The Clinical Trial Assistant supports the planning, execution, and closeout of clinical trials at Cogent, working closely with Clinical Trial Managers and cross-functional study teams. You will support CRO and vendor oversight, study documentation, and quality and inspection readiness activities, taking increasing ownership of assigned workstreams and driving follow-up to ensure timely completion of deliverables. This is a hands-on role for an organized, proactive, detail-oriented person interested in building a career in Clinical Operations within a growing biotechnology company. Responsibilities: Contribute to the overall management of one or more clinical trials, supporting planning, execution, and closeout activities with increasing autonomy and ownership of assigned workstreams. Serve as a key operational point of contact for internal and assigned external study personnel (e.g., investigative sites, vendors), ensuring clear, timely communication and proactive follow-up. Support Sponsor oversight of site management activities, including review of monitoring reports, tracking of site visits, and identification/escalation of site-level issues or trends. Coordinate study team, vendor, and site meetings, including scheduling, agenda preparation, minute-taking, and distribution. Maintain and enhance sponsor-owned study trackers, tools, and dashboards, and review CRO-maintained trackers and reports for accuracy, completeness, and timeliness; coordinate resolution of discrepancies and identify opportunities to improve processes, data quality, and reporting efficiency. Maintain sponsor-owned study records and support oversight of CRO-maintained CTMS and TMF records, performing ongoing TMF quality reviews and reconciliation activities, identifying gaps and coordinating resolution in collaboration with Clinical Trial Manager (CTM) Support Vendor Oversight by reviewing status reports, tracking contracted deliverables, timelines, performance, and documentation, and following up on outstanding action items. Support vendor selection and contracting activities, including scope-of-work reviews and contract routing Identify, troubleshoot, and communicate quality and compliance risks; support implementation of corrective Perform quality control review of study documents and support operational aspects of site payments. Contribute to the development, review, and maintenance of study operational plans and documents; coordinate collaborative review; track reviewer feedback, consolidate comments, and maintain version control. Participate actively in the review of core study documents (e.g., protocol, IB, CSR) and provide operational input. Actively participate in cross-functional project team meetings; capture key decisions, action items, and risks, and drive follow-up to Support development of study and departmental presentations and increasingly contribute to content development Assist with site monitoring activities, audit and inspection preparation, and support inspection readiness activities Qualifications: Bachelor’s degree with at least 3+ years of clinical research experience; experience supporting sp