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He/she will oversee the start-to-end processes for study start-up and ongoing study management. Work with ACC CRU Central to facilitate the initiation of new trials from feasibility review, new study submission, through activation, including tracking of protocols, contracts, and budgets through the start-up process, working with sponsor to schedule SIV's, and maintain communication with study teams and collaborative UPHS departments regarding progress.
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Support the department and execution of clinical data management activities for clinical trials, including study start-up activities, study. Maintain and prepare for final archival of data management documentation relevant to the assigned clinical trials and assist the corporate archivist in assembling and archiving clinical trial data and study documentation.
TemporaryRemoteExpandUpdated 10 days ago - UpvoteDownvoteShare Job
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This job will require 25 to 35 hours per week and is a temporary role expected to last up to six months. maintenance, and study close-out activities. Experience with CRF development and EDC systems, preferably Medidata Rave EDC.
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Serves as the Records Manager for all clinical trials at Corcept throughout the TMF lifecycle (i.e., from study start up to archiving) Reporting to the Vice President of Development Operations, the Senior Manager of Clinical Records will manage the set-up, quality review, documentation, compliance improvement, and archival of study-specific Trial Master Files (TMFs) at Corcept in accordance with SOPs, industry best practice, and ICH/GCP guidelines.
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These tasks may include study feasibility, facilitation of site contracts and budget negotiations between sites and CP, review of document translations, IRB submissions, and other study start up activities, as assigned by the Study Start-Up Manager or designee.
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Lead internal data manager for assigned studies and programs overseeing all data management activities performed by CROs; ensuring major Clinical DM deliverables and milestones are met from study start-up to database lock.
$173,700 - $208,500 a yearFull-timeExpandUpdated 11 days ago - UpvoteDownvoteShare Job
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Leading multi-disciplinary teams to provide study, planning, design, construction administration, and start-up services to water/wastewater treatment utilities in Tennessee, as well as in Alabama, Georgia, and South Carolina as needed.
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The Clinical Trial Associate, SSU will aid in study start up activities for Fractyl's global clinical program, draft SSU documents, site regulatory document review and approval, and IRB/EC and regulatory submissions and approvals.
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1-5+ years of prior experience as a study coordinator or within the pharmaceutical industry, specializing in study start up is required; Join other professionals revolutionizing efficient and seamless study start-up to advance clinical trials.
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Knowledge of clinical research budgeting and the clinical trial life cycle: study start-up through study closure. Disseminates the completed coverage analysis to key stakeholders to expedite clinical research start-up.
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Support study start-up, conduct, and closeout activities. Maintain the study Trial Master File (TMF)/or eTMF and ensure the Investigator Site Files (ISFs) are current and maintained.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Understands clinical trial operational complexities from study start up through enrollment, quality assurance, and study readout. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Performs study start-up duties including the production of a recruitment tool, and progress notes, as well as phone screening patients and identifying participants for trials on site.
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He/She will work closely with the clinical project scientist team and Clinical Leader in Late Development, in collaboration with other functional disciplines, including GCO, Data Management, Statistics, Regulatory, QMMC, and GMS to ensure flawless and integrated execution of study start-up planning, oversight, and reporting of clinical studies in Oncology.
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Assisting with study start-up activities: drafting initial IRB protocol(s), SOPs, recruitment fliers, case report forms (CRFs), etc. Responsibilities include, but are not limited to, recruiting, screening and consenting subjects at both UPenn and Temple through direct patient interaction either in the clinic or via phone, scheduling research subjects' visits, monitoring patients throughout their time on the study, data collection, entry and management, as well as processing data queries.
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