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The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up. Skilled knowledge of local regulatory environment and submission and approval processes and understanding of how these impact study start-ups.
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Coordinates scheduling and set up for audits and all Monitor, study start-up, and close out visits. Plays an integral role in the regulatory/compliance process of all clinical research conducted to include site qualification, and management of the study regulatory documents throughout the site’s participation.
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Assist with study start up including protocol review, case form design, database design, data specifications, data transfer specifications, and review data management and handling plans.
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Proactively coordinate and perform start-up, processing and finalization activities as detailed in our SOPs. Study documentation production and maintenance, data processing, data review.
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Participate in study start up activities. Involved in the preparation of all applicable documents required for the conduct of the study (such as Trial Master File (TMF), Clinical Protocols and Reports.
ExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Lead the coordination of cross-functional department activities to successfully achieve milestones and quality deliverables in study management, including but not limited to study start-up, recruitment, study conduct, and database lock and study close-out with risk and issue management and assurance of TMF inspection readiness.
Full-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), conducting User Acceptance Testing (UAT), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions.
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Support regularly document development, including editing Sponsor documents to match OHSU requirements, as part of study start-up. This TI clinical research assistant II position will support study coordination for several clinical trials and infectious disease epidemiological studies focused on the natural history of NTM, HIV, yellow fever, and other infectious diseases.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Experience in all stages of clinical trial conduct (study start-up, maintenance, database lock, etc.) Work with assigned CTAs and CROs to ensure study activities are documented via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and the Study Monitoring Plan.
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Procure and distribute required study supplies to the appropriate sites for study start-up and ongoing study needs. The Clinical Research Coordinator contributes to the overall operational management of clinical research/trial/study activities from design, set up, conduct, through closeout.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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They will assist the lead RA in any duties that pertain to the study start up process. They will ensure delegation logs and study binders contain complete and up to date records.
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CRC B will assist with preliminary budget proposals, complete perspective reimbursement analyses, and conduct study start-up activities. Position will manage study activities including subject recruitment, data entry, subject visits and follow-up, and regulatory documentation.
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5+ years of experience in clinical research, preferably in a Senior/Lead role at a CRO in Study Start-Up. Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, Global Study Start-Up Project Manager to join our Clinical Operations team.
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Early closing hours with each nights shifts ending at 9pm so you can make it home to study and rest up for the next day. It's an opportunity to meet interesting people, treat our fans to a great dining experience and to start an exciting career in the food-service Industry.
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Overview Medpace is a full-service clinical contract research organization (CRO).
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