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Build and implement patient engagement and recruitment strategies based on each study protocol. Hands-on, data driven coaching including creating and tracking KPIs, education on protocol, appropriate documentation, and management to improve areas of underperformance and/or prevent underperformance.
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Author and review study documents (Protocol, IC, monitoring plans, pharmacy manual, Informed Consent Form, DSMB/Steering Committee/Charters, CSR). Responsible for leading clinical study team to ensure alignment to timelines, risk management and data quality.
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Responsibilities:Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies. MS or PhD in Statistics, Biostatistics or related field.
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Maintain protocol compliance on all clinical trials/studies according to the International Conference on Harmonization-Good Clinical Practice (ICH-GCP), local regulations, and study protocol.
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The Research Nurse Coordinator is a primary resource for study protocol conduct acting as a liaison between the University of Massachusetts Medical School (UMMS), clinical partners (ex. Perform nursing assessments of study participants according to protocol and consult with clinician or Principal Investigator as necessary.
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Complete study protocol independently at visits, including administration of a questionnaire, pulmonary function testing, and collection of blood samples. Communicate with various providers in BWH to implement study-specific procedures, including: radiologists, radiology technicians, PFT technicians, physicians, and phlebotomists.
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Manage all medical writing activities associated with an individual study or product, collaborating across matrixed organizations. Supports clinical research associates and medical doctors in clinical protocol development.
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Top daily responsibilities:¿ Scoping research questions and getting alignment from cross functional team¿ Planning research activities¿ Designing study protocol¿ Creating highlight videos/screenshots¿ Analyzing and interpreting both qualitative and quantitative data¿ Creating findings and recommendation reports from user studies.
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Lead and oversee the vendor in data management activities including database build, data review, and database lock, following requirements defined in the clinical protocol and in alignment with industry best practice guidelines and Caribou Clinical Development data standards and processes.
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Good understanding of cGMPs and good documentation practices in order to prepare system life cycle technical documents such as URS, FRS, VMP, protocol generation and execution to support FAT, SAT, commissioning, qualification (IQ, OQ), SOPS, Validation (PQ, DS, CV, PV), FMEA and Validation Master Plan.
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Additional duties might include R&D study protocol reviews and execution support, coordination of manufacturing activities with other Client sites as well as external vendor management. The Project Coordinator will work closely with the Program Manager / Core Team Leader.
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Protocol Submissions: Prepares and reviews clinical trial documents for submission of new and amended or modified documents for the Institutional Review Board (IRB), the National Cancer Institute (NCI), the Food and Drug Administration (FDA), sponsor or supporters and other approving entities.
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Responsibilities include; patient screening and recruitment, coordination of care of the research patient, protocol implementation, data collection and query resolution, and submission to the Institutional Review Board (IRB.
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The Pharmacist will review protocol documents, draft instructions, dispense investigational medication, provide supervision, perform educational activities, communicate with the sponsor and study staff, participate in patient care, maintain overall responsibility for pharmacy operations in the assigned area and perform other duties consistent with the job classification and as required.
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Responsible for overall management of the trial(s) to ensure compliance with study protocol, FDA, NIH and IRB policies. Oversee and coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies.
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