Senior Clinical Trial Associate
About The Position
Cogent Biosciences is a publicly traded biotechnology company developing precision therapies for patients with unmet medical needs. Its lead program, bezuclastinib, is designed to inhibit KIT exon 17 mutations and is being studied in systemic mastocytosis and gastrointestinal stromal tumors. The Clinical Trial Assistant supports planning, execution, and closeout of clinical trials, working closely with Clinical Trial Managers and cross-functional study teams. The role supports CRO and vendor oversight, study documentation, and quality and inspection readiness activities. It takes increasing ownership of assigned workstreams and drives follow-up to ensure deliverables are completed on time. This is a hands-on opportunity for an organized, proactive, detail-oriented person interested in a Clinical Operations career at a growing biotechnology company. The position is associated with Cogent’s Waltham, Massachusetts, and Boulder, Colorado, locations. The Waltham office has an open, collaborative environment, free on-site parking, and gym facilities in the building. The Boulder office is a scientific hub for the company’s discovery research organization.
Requirements
- Bachelor’s degree and at least 3 years of clinical research experience.
- Working knowledge of ICH GCP and its application to clinical trial documentation and operations.
- Strong organizational skills and attention to detail, including the ability to maintain accurate records and manage competing priorities and deadlines.
- Ability to take ownership of assigned tasks, proactively follow up, and drive action items to completion.
- Strong written and verbal communication skills.
- Ability to work effectively on multiple cross-functional teams with increasing independence, incorporate feedback, and seek guidance when needed.
- Proficiency with Microsoft Office.
- Experience using SharePoint or OneDrive to manage shared documents and coordinate review.
Nice To Haves
- Experience supporting sponsor or CRO clinical operations.
Responsibilities
- Contribute to management of one or more clinical trials, supporting planning, execution, and closeout with increasing autonomy and ownership of assigned workstreams.
- Serve as an operational contact for internal and assigned external study personnel, including investigative sites and vendors, and ensure clear, timely communication and proactive follow-up.
- Support sponsor oversight of site management, including reviewing monitoring reports, tracking site visits, and identifying or escalating site-level issues and trends.
- Coordinate study team, vendor, and site meetings, including scheduling, preparing agendas, taking minutes, and distributing them.
- Maintain sponsor-owned study trackers, tools, and dashboards; review CRO-maintained trackers and reports for accuracy, completeness, and timeliness; coordinate discrepancy resolution and identify process, data-quality, and reporting-efficiency improvements.
- Maintain sponsor-owned study records and support oversight of CRO-maintained CTMS and TMF records, including ongoing TMF quality reviews and reconciliation; identify gaps and coordinate their resolution with the Clinical Trial Manager.
- 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, including scope-of-work reviews and contract routing.
- Identify, troubleshoot, and communicate quality and compliance risks; support corrective actions.
- Perform quality-control reviews of study documents and support operational aspects of site payments.
- Contribute to developing, reviewing, and maintaining study operational plans and documents; coordinate collaborative review, track reviewer feedback, consolidate comments, and maintain version control.
- Participate in reviewing core study documents, such as the protocol, IB, and CSR, and provide operational input.
- Participate in cross-functional project team meetings, capture decisions, action items, and risks, and drive follow-up.
- Support development of study and departmental presentations and increasingly contribute to their content.
- Assist with site monitoring activities, audit and inspection preparation, and inspection readiness.
Benefits
- Competitive salary
- Target bonus of 10%
- Ongoing stock awards
- 100% coverage of medical, dental, and vision premiums for employees and their families
- Funding for up to 75% of in-network deductibles
- 401(k) match with immediate vesting
- Generous paid time off
- 12 weeks of fully paid parental leave
- Paid family and medical leave for all employees regardless of location
- Company-paid short-term disability coverage for up to 20 weeks
- Wellness programs
- Tuition reimbursement
- Inclusive family-forming support
- Free on-site parking at the Waltham office
- Gym facilities in the Waltham office building
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What This Job Offers
Job Type
Full-time
Career Level
Senior
