Senior Clinical Trial Associate

Clinical Trial Associate This individual will assist the clinical operations team in the day-to-day operations, study start up, execution, and closeout of trials across the portfolio.

Responsibilities

Support the day-to-day operations of trials to ensure completion per established project team goals and objectives in compliance with ICH/GCP guidelines, from study start-up to close-out. g. site start up status, screening and enrollment, bioanalytical samples, clinical supplies) Ensure timely maintenance of the Trial Master File (TMF) according to regulatory guidance and internal SOPs.

Lead periodic TMF review and reconciliation activities throughout the lifecycle of trials. Identify issues and propose mitigations as part of CRO oversight of TMF related activities.. Participate in and ensure appropriate documentation of clinical team meetings, including meeting minutes, agendas, and action items.

) Oversee study vendors including central labs, IRT and other service providers. Manage vendor POs and trial payments (including budget reconciliation), including invoice review, approval, and tracking. , drug product, ancillary supplies).

Lead and coordinate development and team review of study documents including protocols, informed consent forms, and study-specific plans. Assist the Clinical Trial Manager with site start-up activities, communications, and tracking Assist in data reviews, tracking of data entry and query status as needed. Education, Skills, Experience Two plus years of relevant trial support experience (including CRO or vendor oversight experience).

BA/BS degree preferred. ) Oncology experience is favorable. General working knowledge of drug development and ICH/GCP guidelines and clinical trial operations is required.

Ability to work independently and take initiative on projects under minimal supervision. Excellent organizational skills; prefers and can adapt to multiple priorities in a fast-paced and fluid work environment. Excellent interpersonal, written, verbal, administrative, and computer skills.

This position is classified as exempt. The anticipated annual base salary range for candidates who will work in Watertown is $68,883 to $94,945. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, and other factors.

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