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Clinical Research Scientist

Company: Beacon Hill Staffing Group - Pharma
Location: Worcester
Posted on: September 13, 2019

Job Description:

This position serves a key role within the assigned clinical development team. The Clinical Research Scientist (CRS) works closely with the study team and medical director to support the activities associated with one or more clinical studies. The CRS leads or co-leads a study or study activities. This position collaborates with clinical team members as well as with functions outside of clinical to provide high quality and timely deliverables. The CRS is responsible for achievement of personal goals which support study team, project team, and corporate goals. Lead or support assigned study level activities for 1 or more clinical studies with minimal supervision; may lead or co-lead a study Thorough understanding of assigned protocol and protocol requirements Understands work to be done; plans ahead Lead/Co-Lead or Support study start-up/conduct/close-out activities as applicable Preparation, storage, maintenance of clinical documents (TMF) Protocol development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments, and ensuring high quality final document) Review and validation of clinical study reports (CSRs); thorough understanding the connection between the data and the CSR Author/coordinate and review Regulatory Documents (e.g., IB, Briefing Books) Author/Review Informed Consent Forms (ICF); review/support finalization of regional and site ICFs as needed; ensure high quality, appropriate reading level text, and alignment with protocol) Planning of site and CRA training; including logistics, materials and presentation Country/site selection activities Collaboration with Clinical Operations for budget preparation, CRO scope of work, etc. (i.e., review and provide feedback on activities/instructions/deliverables related to study data, IVRS, central labs, patient reported outcomes) Study committee (e.g., DMC) activities such as charters, meetings, presentation preparation Investigator Meeting and SIV planning/facilitation/presentation Activities related to data generation and validation, including CRF creation, clinical data review, communication as needed to resolve data queries, draft/update/review data review plans, support Clinical Research Physician in data review (generation of reports, action plans, trend identification), etc) May support clinical development planning (assist CRP/Program Lead CRS with analysis of data and review of literature to support future planning) Collaborate with study team members (Clinical, Clinical Operations, Data Management, Statistics, Drug Safety, IMSC, Regulatory Affairs, Translational Medicine and Project Management) to ensure that key milestones are met on time and with high quality Provide guidance and scientific expertise within team, across department, and across functions Lead the planning and preparations for external/stakeholder meetings (e.g., IMs) Present data/information to external investigators or study staff (e.g., SIV presentations) Identify and liaise with external partners Identify, escalate current/active/future issues; propose and enact solutions Qualifications Masters, Pharm D orPhD in related pharmaceutical science strongly preferred RN/MSN, NP or PA with oncology clinical trial experience will be considered 1+ years' experience in CR&D roles/responsibilities or equivalent; Oncology clinical research expereince highly desired Proficient knowledge of GCP/ICH, drug development process from discovery to registration, study design, statistics, clinical operations within the oncology therapeutic space Proficient knowledge and skills to support program specific data review, trend identification, data interpretation Proficient in Medical Terminology and medical writing skills Excellent verbal, written, communication and interpersonal skills. Must be able to effectively communicate and collaborate across functions and job levels Ability to assimilate technical information quickly Strong sense of teamwork; ability to lead team activities Proficient critical thinking, problem solving, decision making skills Understanding of functional and cross-functional relationships Adaptable / Flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism) Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), or similar data reporting tools

Keywords: Beacon Hill Staffing Group - Pharma, Worcester , Clinical Research Scientist, Healthcare , Worcester, Massachusetts

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