Clinical Trial Associate

Verastem•Boston, MA

7d•$86,000 - $100,000

About The Position

At Verastem Oncology, we're advancing innovation and addressing the urgent needs of patients living with cancers driven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance. The FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy specifically for women living with recurrent KRAS-mutated low-grade serous ovarian cancer, a rare cancer with significant unmet need. We’ve successfully launched this innovative combination therapy in the U.S. and are exploring regulatory pathways for Europe and Japan. We are continuing to advance our pipeline of drugs that we believe will help block cancer cell survival, inhibit tumor growth, and overcome treatment resistance. With clinical trials underway, we have an exciting opportunity to shape the future of cancer care and make a meaningful impact in the lives of patients. Summary: Responsible for assisting and providing support to the members of the clinical operations project team to facilitate the operational execution of the clinical trial processes in accordance with regulatory guidelines and ICH/GCP standards.

Requirements

Bachelor's degree or nursing degree is required. Scientific/health care field preferred, but not required.
Minimum of 4 years’ experience in relevant field (e.g. clinical site, CRO, Sponsor or clinical trial vendor).
Relevant experience in clinical research or related field.
Adequate Good Clinical Practice training.
General knowledge of guidelines governing clinical research.
Comfortable with technology and ability to learn new systems quickly.
Experienced with Veeva TMF.
Strong knowledge of MS Word, Excel, PowerPoint and Outlook.
Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
Must be able to professionally interact and communicate with visitors, vendors and individuals at all levels of the organization.
Must be able to work in a fast-paced environment with demonstrated ability to work on multiple competing tasks and demands.
Ability to work successfully within a cross-functional team.

Responsibilities

Manages trial related documents in the Veeva Vault Trial Master File (TMF); manages user access and facilitate training for internal/external users as needed; trains new users.
Uploads and reviews TMF documents for completeness, accuracy and compliance with protocol and applicable regulations, standard operating procedures and best practices.
Performs quality checks and follow-up on resolution of open issues to ensure cross functional study team members are compliant with use of required documents within the TMF.
Audits TMFs and resolves discrepancies with minimal supervision.
Creates and maintains internal folders on company share drive(s).
Manages study investigator CDAs, contract approval and purchase order creation.
Coordinates cross function project team meetings with Clinical Project Manager and assists in preparation of agendas, minutes and tracking of action items.
Assists in the creation of study materials, including but not limited to documents, presentations and reports.
Supports CPM to established and maintain the tracking tools for project metrics such as site activation, patient enrollment and site contacts.
Reviews and assists in the collection of essential documents for completeness and compliance with SOPs, the protocol and appropriate regulations.
Creates and reviews IMP release packet prior to initiation; review background information of potential new sites (e.g. debarment check, Inspection history, etc).
Assists study team and sites with preparation for audits/inspections.
Participates in inter-departmental workgroups to create or enhance processes.
May participate in the training of CRO teams, investigators and study team members.
May serve as the point of contact for vendors and oversee selected vendor activities.
May be responsible for updating Clintrials.gov.
Performs administrative tasks to support team members with clinical trial execution, as needed.