Clinical Trial Associate

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.
• Develop and maintain internal trial trackers and implement updates to presentations and reports based on pertinent trial information (e.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.
• Assist with planning and conduct of internal and external meetings (study meetings, study site meetings, vendor meetings, Clinical Advisory Board meetings, etc.)
• 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.
• Support the set-up and management of clinical trial supplies and biosample management where needed (e.g., 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. (Additional experience may substitute for a BA/BS degree.) 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.