Cogentbiosciences
Senior Clinical Trial Associate
Waltham, Massachusetts, United States. Posted a month ago
The role
The Clinical Trial Assistant supports the planning, execution, and closeout of clinical trials. This role involves supporting CRO and vendor oversight, study documentation, and quality and inspection readiness activities.
What you will do
- Contribute to the overall management of one or more clinical trials.
- Serve as a key operational point of contact for internal and assigned external study personnel.
- Support Sponsor oversight of site management activities.
- Coordinate study team, vendor, and site meetings.
- Maintain and enhance sponsor-owned study trackers, tools, and dashboards.
- Maintain sponsor-owned study records and support oversight of CRO-maintained CTMS and TMF records.
- Support Vendor Oversight by reviewing status reports and tracking deliverables.
- Support vendor selection and contracting activities.
- Identify, troubleshoot, and communicate quality and compliance risks.
- Contribute to the development, review, and maintenance of study operational plans and documents.
Required qualifications
- Bachelor’s degree
- 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
- Demonstrated ability to take ownership of assigned tasks
- Strong written and verbal communication skills
- Ability to participate and work effectively on multiple cross-functional teams
- Proficiency with Microsoft Office
- Experience using SharePoint or OneDrive to manage shared documents and coordinate review
Nice to have
- experience supporting sponsor or CRO clinical operations
Benefits
- competitive salary
- bonus
- ongoing stock awards
- 100% medical, dental, and vision premiums for you and your family
- funding 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
About the company
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.