About the role
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. 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. 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. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states. Recruitment fraud statement Please be aware of recruitment fraud and related job scams, where scammers present themselves as recruiters but are seeking to steal money or personal information. Keep the following in mind to protect yourself: Treeline Biosciences will never ask for money from you as part of our recruitment process. Do not provide bank details or pay somebody for the promise of a job at Treeline. We do not conduct interviews through RingCentral, Skype or Telegram. Our job openings are first posted to treeline.bio/careers. If you locate a listing for a Treeline job on another site, please ensure it is also posted on our careers website. You can find more information about job scams at consumer.ftc.gov/articles/job-scams. To report job scams, head to ReportFraud.ftc.gov. Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters) The Human Resources team manages the recruitment and employment process for Treeline Biosciences. To protect the interests of all parties involved, Treeline Biosciences will only accept resumes from a recruiter if an executed search agreement directed to the particular position or positions is in place at the start of the recruitment effort. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.