Clinical Trial Associate

About Verastem Oncology

Verastem Oncology focuses on addressing critical challenges faced by patients with cancers driven by RAS/MAPK pathway mutations, which significantly contribute to tumor growth and treatment resistance. The company successfully secured FDA approval for AVMAPKI FAKZYNJA CO-PACK, pioneering a treatment for women with recurrent KRAS-mutated low-grade serous ovarian cancer, a rare form with significant unmet needs. Having launched this therapy in the U.S., Verastem is also pursuing regulatory pathways in Europe and Japan while continuously advancing its drug pipeline to inhibit tumor progression and overcome treatment resistance.

Role Summary and Responsibilities

The Clinical Trial Associate supports clinical operations teams to ensure smooth execution of clinical trials adhering to regulatory guidelines and ICH/GCP standards. Key duties include:

• Managing trial-related documentation in Veeva Vault Trial Master File (TMF), including user access management and conducting user training.
• Uploading and reviewing TMF files for completeness, accuracy, and compliance with protocols and regulations.
• Performing quality checks and coordinating resolution of TMF issues to ensure team compliance with documentation requirements.
• Conducting TMF audits and independently resolving any discrepancies.
• Organizing and maintaining internal digital filing systems on company shared drives.
• Handling the management of investigator Confidential Disclosure Agreements, contract approvals, and purchase order preparation.
• Collaborating with Clinical Project Managers to schedule and facilitate project team meetings, prepare agendas, minutes, and monitor action item progress.
• Assisting in the preparation of study documents, presentations, and reports.
• Supporting project metric tracking, including site activation, patient enrollment, and site communications.
• Reviewing essential documents for completeness and regulatory compliance.
• Preparing Investigational Medicinal Product release packets and performing background checks for new clinical sites.
• Assisting teams and sites to prepare for audits and inspections.
• Contributing to interdepartmental initiatives aimed at process improvements.
• Training vendors, CRO teams, investigators, and study team members as needed.
• Serving as a contact point for vendors and overseeing certain vendor activities.
• Updating clinical trial registrations, such as Clintrials.gov, where applicable.
• Performing administrative tasks that facilitate clinical trial execution.

Qualifications

• Bachelor’s degree or nursing degree required; scientific or healthcare-related education is preferred but not mandatory.
• At least four years of experience working in clinical research or related settings such as clinical sites, CROs, sponsors, or clinical vendors.
• Good Clinical Practice (GCP) training and knowledge of clinical research guidelines.
• Proficiency in using Veeva TMF and comfort with quickly learning new technologies.
• Strong skills in Microsoft Office suite including Word, Excel, PowerPoint, and Outlook.
• Demonstrated attention to detail, excellent communication abilities, and capacity to operate in a fast-paced environment managing several priorities simultaneously.
• Ability to work effectively as part of a cross-functional team and interact professionally with diverse stakeholders at all organizational levels.

Compensation and Additional Information

The anticipated base salary range for this position is between $86,000 and $100,000, subject to factors such as experience, skills, education, internal equity, and market conditions. The compensation package also includes eligibility for an annual bonus, equity incentives, and a competitive benefits plan.