• Regulatory Administrator - Research

    Location US-NY-New York
    Posted Date 2 weeks ago(6/29/2018 11:00 AM)
    Job ID
    2018-10320
    Category
    Administrative/Clerical Support - All Openings
    Emp Status
    Regular Full-Time
    Hours per Week
    35
    Shift
    Days
  • Overview

    HSS Clinical Research Administration- Regulatory Administrator (or Manager based on experience level)

    Clinical Research Administration provides services to facilitate all functions from clinical trial design conception through to a final contract and submission to the IRB, to study execution and closeout.

    Currently these services include Biostat Core, Scientific Review Panels (CRP), IRB, and pre and post award support. As research collaborations continue to grow at HSS among multidisciplinary teams, including scientists, surgeons and clinicians, the portfolio of clinical trials are becoming more complex and highly regulated.  For example, the “First-in-human trials” are a key step in medicines development, where a medicine already tested in vitro, in animals or in other preclinical studies is administered to people for the first time.  The safety and well-being of trial participants should always be the utmost priority when designing early clinical trials.

    Under the direction of the Executive Director for Clinical Research Administration and in collaboration Biostat/Data Cores, CRP and as member of the IRB Administration, the Regulatory Administrator will directly implement and provide oversight and support of the following functions:

    HSS IRB Day to Day Administrative Support:

    • Direct the “single IRB model” including SMARTIRB and other “central IRBs” for federally funded studies.
    • Act as Institutional Liaison with Western IRB and other external IRBs.
    • Act as Institutional Liaison with Researchmatch.com registry and other recruitment tools.
    • Provide administrative support to the IRB in collaboration with the IRB administrator and Chair.
    • Assist and participate in monthly HSS CRPs and IRB meetings.
    • Evaluate projects that require Data Use Agreements are required for data sharing/registries.
    • Assist IRB Administrator/Chair with assessing IND/IDE Exemptions as part of the IRB review
    • Assist with periodic updating of ECAP smart form to reflect regulatory changes as per the new common rule.

    The Regulatory Administrator will also provide guidance on submitting Investigational New Drug (IND) applications and Investigational Device Exemptions (IDE) and assist with the regulatory responsibilities of a “sponsor-investigator.”

    Regulatory Support/Oversight:

    • Provide regulatory support to project teams submitting investigator initiated protocols to external agencies such as FDA, EU, DOD, NIH, Foundations and Industry Sponsors, etc.
    • Assist Investigators with IND, Cellular therapy & IDE submissions, annual reports, and review of MEDWATCH submissions.
    • Participate in pre- IND meetings with the PI and the FDA.
    • Liaison with research pharmacy on drug studies that require services.
      • Assist with biosafety committee (IBC) applications for cellular therapy protocols and registration with NIH and screening of modifications to determine whether convened IBC review is required
      • Assessment of whether the study would benefit from public RAC review in accordance with NIH Guidelines for initial site(s).
      • In collaboration with the PI and biostat core develop DSMB plans when applicable
      • Assist Investigators with regulatory requirements for “home grown” clinical trials and discoveries in collaboration with Pre-Award and the Office of Sponsored Program.
      • Centralize clinicaltrials.gov services for Investigator Initiated Studies, including interpreting of data analysis plan to assure results are reported in a timely fashion as per January 2017 conditions enforcing deadlines for regular updates, comments from CT.gov, and results reporting.
      • Provide training workshops to Research Institute Scientists and HSS faculty
      • Prepare and present metrics to Senior Leadership.
      • Other duties and special projects as assigned.

    Qualifications

     

     

    Background in life sciences, regulatory and/or pharmaceuticals sciences with 3-5 years of experience with IND, Cellular therapy, IDE and/or other regulatory applications.

     

    Masters and/or PhD degree preferred.

     

    • Solid understanding of regulatory application process and the basis of regulations affected proposed and/or marketed products preferred.
    • Solid knowledge of regulatory requirements related to 21 CFR & European Medical Device directives.
    • Capacity to communicate regulations to clinical investigators and project team.
    • Ability to manage relationship with investigators, sponsors, FDA and other regulatory agencies when applicable.
    • Detail oriented and be proficient at reviewing and editing scientific documents.
    • Excellent written and oral communication skills.
    • Advanced computer skills in Microsoft office.
    • Working knowledge of REDCAP, Electronic IRB systems, clinicaltrials.gov and SAS program.

     

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