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Assist with Institutional Review Board (IRB) filings and inquiries, and assist in the preparation of manuscripts, grant proposals, and research related presentations. Assist with completing and maintaining regulatory correspondence under direction of project manager, including participating in preparation of documents for the IRB and other regulatory boards, creation and maintenance of regulatory binders.
$37,220 - $47,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Recruits, consents and enrolls subjects according to ICH/GCP regulations, and subjects' rights through institutional IRB, federal and state regulations; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate.
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Draft and submit Institutional Review Board (IRB) protocol submissions. Full-time Program Manager to serve on the Brothers=Connect project, an upstream suicide prevention program for Black male teens ages 13-19 in Youth Basketball Leagues (i.e., YMCA), Boys & Girls Clubs, and other community-based organizations across New York City. This 2- to 4-year position is funded from a grant from the Dayton Foundation.
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Assist in all aspects of clinical trials, such as IRB preparation, IND applications, patient scheduling, budget preparation, and maintains patient accrual information in a database. The RA may be responsible for the following activities: recruiting and evaluating suitability of potential participants for clinical trials; collecting, entering and organizing patient data; scheduling patients for study visits; submitting paperwork to provide checks for subject payment, contacting patients in follow up; and, maintaining and updating imaging and research data; and aides the PI in the IRB submission process.
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Establishes and maintains processes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies and procedures and regulations.
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Ensure each clinical research site collects documents and reports the research data to the appropriate licensed staff member and the PI for assessment in a timely manner as per the IRB-approved protocol.
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Oversee CRI study start-up from the regulatory standpoint to ensure that site meet Sponsors, IRB, and other regulatory authority’s requirements. Job DescriptionThe Specialist - Regulatory Affairs will apply a comprehensive understanding of research regulations, ethics and guidelines, and analyze research IRB submissions to determine compliance with regulation.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Monitor IRB submissions to ensure all studies have entered OCT workflow per policy. Review IRB closure report and initiative close out process with research finance team. Monitor IRB submissions to ensure all studies have entered OCT workflow per policy.
$17.74 - $26.61 an hourFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Assists with the preparation and review of IRB protocols. Our medical practices serve communities throughout New York City, and our faculty provide comprehensive care at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian/Lower Manhattan Hospital, NewYork-Presbyterian Hospital/Brooklyn Methodist Hospital, NewYork-Presbyterian Hospital/Westchester Behavioral Health Center, and NewYork-Presbyterian/Queens.
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Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
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Attend IRB meetings, start the voting system, count the votes of the members, collate reviewer comment sheets, input results into myIRB/database, and close out the voting process Attend staff post board meeting for final confirmation of votes and motions.
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Experience with the institutional review board (IRB) process for human subjects' research and IRB approved video collection. drone, UAV), and ground mobile (e.g. cell phone, auto mounted, etc.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Assists with grant/protocol preparation and submission to IRB, OCR or OSP under direction of research coordinator under the direction of the PI and with answering IRB stipulations to obtain final approval; documents IRB approval and contract approval.
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Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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Creating compliance submissions and amendments (e.g., IRB) and ensuring all project staff complete and maintain necessary compliance trainings. This beautiful mountain landscape offers outdoor enjoyment in all seasons, with over 300 days of sunshine annually.
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