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Clinical Trial Associate

Company: Beacon Hill Staffing Group - Pharma
Location: Lowell
Posted on: May 7, 2021

Job Description:

his role will focus on providing clinical study support during start-up, maintenance and close out. Additionally, s/he will help to ensure clinical operational deliverables and timelines are met across the development program(s). Reporting to the Clinical Trial Manager, this individual will be responsible for overall operational management of multiple clinical development studies, including: Key Responsibilities Support interdisciplinary activities, participate in Clinical Trial Working group(s) meetings in order to meet goals and establish timelines Provide support in managing Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation Liaise with clinical sites as appropriate to ensure optimal sponsor-site relationships Assist in preparation of informed consent forms, regulatory packets, clinical study reports and other clinical documents as necessary Assist in the creation of study materials, including but not limited to documents, presentations, reports and study plans Conduct initial review and tracking of invoices and study payments Establish and maintain tracking tools for assigned trials Generate, review and approve Trial Master File (TMF) document workflows and perform TMF review Participate in team meetings and assist in the preparation of agendas, minutes and tracking of action items Perform administrative tasks to support Clinical Operations and team members as needed Provide support to all aspects of study progress (from planning to close-out), to assure adherence to intended timelines and achievement of study goals, while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines. Minimum Requirements Bachelors degree (scientific or healthcare discipline preferred) plus at least 1-4 years in clinical and drug development (more experienced candidates will be considered for the Sr. title) Experience in hematology/oncology preferred Proven experience in the oversight of the operational aspects of all stages of clinical studies, preferably in a global environment Knowledge of ICH GCP and knowledge of Medical Terminology strongly preferred Ability to organize and manage multiple priorities required Strong oral and written communication skills required Proficiency in Microsoft Word, Excel and PowerPoint Ability to multitask with significant attention to detail Ability to work independently and in a matrix team environment Competencies Applies creative, original ideas to accomplish work; identifies more than one way to solve problems. Builds networks internally and externally to stay relevant on new discoveries, trends and uses them to make meaningful connections to drive innovation and learning. Grows knowledge and capability in self and others by teaching, coaching and mentoring. Work in and with teams to achieve outcomes that individuals would not have been able to achieve alone. Maintains line of sight to team and company priorities; understands and values all areas of business. Creates connections beyond own role/function. Possesses technical or professional expertise and is able to apply it to create value/impact. Acts with a sense of urgency; with the end result in mind and is able to follow through to deliver exceptional results. Taking an approach to continuous improvement; anticipates and addresses capability gaps to prepare for future challenges. Takes accountability as individuals and as teams; acts like an owner.

Keywords: Beacon Hill Staffing Group - Pharma, Lowell , Clinical Trial Associate, Healthcare , Lowell, Massachusetts

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