Senior Clinical Trial Associate

Cogent Biosciences, Inc.; Waltham (MA); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical premiums covered

401(k) match

Paid parental leave

Paid time off

Tuition reimbursement

Job summary

Cogent Biosciences, Inc. in Waltham, MA, seeks a Clinical Trial Assistant to support planning, execution, and closeout of clinical trials, working with Clinical Trial Managers and cross-functional study teams.

You will help oversee CROs and vendors, maintain study trackers, TMF and CTMS records, and drive on-time deliverables with proactive communication and meticulous documentation.

Qualifications

• Bachelor’s degree with at least 3+ years of clinical research experience; experience supporting sponsor or CRO clinical operations preferred.
• Working knowledge of ICH GCP and its application to clinical trial documentation and operations.
• Demonstrated ability to take ownership of assigned tasks, proactively follow up, and drive action items to completion.

Responsibilities

• Contribute to overall management of one or more clinical trials with increasing autonomy and ownership of workstreams.
• Serve as operational contact for internal and external study personnel to ensure clear communication and follow-up.
• Support sponsor oversight of site management, monitoring reports, site visits, and issue escalation.
• Coordinate meetings, prepare agendas, take minutes, and distribute action items.
• Maintain sponsor study trackers, tools, and dashboards; review CRO trackers for accuracy and timeliness.
• Oversee TMF/CTMS records and coordinate quality reviews and reconciliation with CTM.
• Support vendor oversight, status reports, deliverables, and action tracking.
• Assist with vendor selection, contracting, scope-of-work reviews, and routing.
• Identify quality and compliance risks; support corrective actions and quality reviews of documents.
• Contribute to development and maintenance of study plans; track feedback and version control.
• Participate in core study document reviews (protocol, IB, CSR) and provide operational input.
• Attend cross-functional project meetings; capture decisions and risks and drive follow-up.
• Support development of study and departmental presentations and content.
• Assist with site monitoring, audit readiness, and inspection preparation.

Skills

Organizational skills

Attention to detail

Communication skills

Multitasking

Microsoft Office

SharePoint/OneDrive

Education

Bachelor's degree

Tools

CTMS

Job description

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 sponsor or CRO clinical operations preferred
• Working knowledge of ICH GCP and its application to clinical trial documentation and operations.
• Strong organizational skills and attention to detail, with the ability to maintain accurate records and manage competing priorities and deadlines
• Demonstrated ability to take ownership of assigned tasks, proactively follow up, and drive action items to completion
• Strong written and verbal communication skills.
• Ability to participate and work effectively on multiple cross-functional teams with increasing independence, incorporating feedback and seeking guidance when needed
• Proficiency with Microsoft Office and experience using SharePoint or OneDrive to manage shared documents and coordinate review.

Salary Range:

$100,000- 120,000 USD

Exact compensation will vary based on skills, experience, and location.

Our Locations

Waltham, MA: Our headquarters is located in the Greater Boston life sciences community, with an open , collaborative office environment designed to support teamwork and connection. Employees benefit from convenient on-site amenities, including free on-site parking and gym facilities in the building.

Boulder, CO: Our Boulder location is home to Cogent’s discovery research organization and a key scientific hub with strong leadership based on site . Situated in the greater Denver-Boulder biopharmaceutical corridor , this office plays a central role in advancing our discovery efforts and pipeline .

Our Offer To You

At Cogent Biosciences, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that se t s us apart . We cover 100% of medical, dental, and vision premiums for you and your family, and help reduce out-of-pocket costs by funding up to 75% of in-network deductibles . Our benefits also include a 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, and company-paid short-term disability coverage for up to 20 week s . A dditional perks like wellness programs, tuition reimbursement, and inclusive family-forming support help you thrive at work and beyond.

We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need .