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CRA management, Monitoring, study plan writing, SOP development, Clinical trial management systems, Clinical trial, Clinical research, Project management, SOP, trip report, edc. Serve as primary reviewer of monitoring visit trip reports.
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The Milestone One Site Coordinator supports a medical institution in clinical trial related activities associated with assessment of feasibility of new potential clinical studies, assistance in patient flow at the institution in currently on-going clinical trials, assistance with data entry into study related EDC systems, contact with CRO or sponsor representatives in order to schedule and conduct monitoring visits as well as resolve study specific issues at the medical institution.
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Perform study tasks such as processing and shipping of research samples, monitoring temperature logs, and updating research calendar adhering to GCP and sponsor requirements. The CRC II will participate in tasks related to numerous phases of clinical research including recruitment, consenting, data collection, monitoring, completion, and reporting.
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Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Boards, Contract, and Training, developing process improvements.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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5 years of medical device/sponsor/CRO/Pharma clinical field monitoring experience, quality assurance/control and regulatory compliance. Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.
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These include: daily revenue reports, monthly revenue/expense variances, budget summaries, long-term plan reports, capital planning/monitoring reports, clinical trials fund accounting, invoice accounting, etc.
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Evaluates response to treatment, treatment toxicities and adverse drug reactions and reports appropriately to the principal investigator, the Institutional Review Board and the study sponsor. The primary purpose of the Research Nurse position is to provide clinical evaluation, coordination, implementation, and monitoring of patients enrolled in department research protocols.
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Conducts Sponsor quality monitoring/oversight visits to sites and /or CRA performance assessment in adherence to GCP, corporate SOPs and protocol as needed. Minimum of 7-8 years progressive experience in clinical research management experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting with 1+ year of supervisory experience (Sponsor company is preferred.
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Support study initiation, monitoring, audit and close-out phases of assigned clinical trials as prescribed in the sponsor SOPs and study monitoring plan; The CRA may also assist with data management, vendor management and site monitoring as needed.
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Minimum of two years of CRA experience, with clinical site monitoring experience preferred; Facilitate timely and accurate communication flow between the clinical study sites, sponsor and applicable vendors.
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Manages budget spending to guidelines, monitoring and reviewing allocation of research funds, grant balances and charges, ensuring appropriate use of funds under investigator control, both in terms of sponsor/external regulations and Institute policy.
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Represent Sponsor with the highest ethical and professional standards with all business contacts including, but not limited to the following representatives: investigator and site staff, clinical trial team, Regulatory Affairs, Site Monitoring staff, other departments within Clinical Operations, and if required clinical trial vendors.
$50 - $54 an hourFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Review of research budgets to ensure compliance with applicable regulations, sponsor/funder terms and conditions, and institutional standards. + Coordinates and provides post-award activities including submission of technical and financial progress reports, budget revisions, time and effort, invoice tracking and financial monitoring, forecasting results, funding trend analyses, no-cost extension requests, prior approval requests, audits, close-out, etc.
$24.67 - $37.01Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Collaborate with other administrative offices, such as the BILH Office of General Counsel, IRB Office, Information Services and Research Finance to ensure compliance with sponsor and institutional policies.
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DesiredExperience using ERP SystemsAPICS CPIM or CSCP CertificationExposure to CNC Machining a plusTriangle does not sponsor for employment visa status. Responsible for procurement, short and long-term capacity planning, and sales forecasting, as well as maintaining the daily production schedule, monitoring new project progression, and ensuring inventory accuracy.
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sponsor monitoring jobs
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