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
Target Bonus: 10%
Exact compensation will vary based on skills, experience, and location.
Our LocationsWaltham, 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 YouAt Cogent Biosciences, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that sets 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 weeks. Additional perks like wellness programs, tuition reimbursement, and inclusive family-forming support help you thrive at work and beyond.
