• sIRB Reliance Analyst

    Location US-MA-Brookline
    Job Posted Date 1 month ago(9/6/2019 1:09 PM)
    Job ID
    2019-16883
    Category
    Clinical Research
    Type
    full time
    Grade
    23
  • Overview

    The Office for Human Research Studies (OHRS) is responsible for scientific and IRB review of all oncology research undertaken under the umbrella of the Dana-Farber/Harvard Cancer Center. In addition to the research that is under the purview of the DFCI IRB, DF/HCC participates in almost 200 protocols that are under review by an external single IRB (sIRB). The sIRB Reliance Analyst is responsible for managing and implementing reliance agreements and the creation and maintenance of sIRB policies, procedures, and educational resources for the DF/HCC research community. The sIRB Reliance Analyst is the primary point of contact and source of guidance for single IRB review and reliance/master agreements, and reports to the OHRS Director. 

    Responsibilities

    PRIMARY DUTIES AND RESPONSIBILITIES:

    • Serve as the primary point of contact for DF/HCC investigators and research staff whenever the DFCI IRB will either rely on the review of an external sIRB or serve as the single IRB for other sites.
    • Conduct independent, in-depth reviews of requests to rely (either requests for external sites to rely on DFCI IRB, or requests for the DFCI IRB to rely on an sIRB) and determine whether the requests are in accordance with DFCI policies and procedures.
    • Work with the OHRS Director, DFCI leadership, and DFCI general counsel to reviews, negotiate terms and facilitate the execution of IRB reliance agreements.
    • Act as the liaison between DF/HCC investigators and others (e.g., DF/HCC institutional IRBs, external sIRBs, sponsors) to coordinate and implement reliance agreements.
    • Organize, track and maintain records of all reliance agreements and the covered research activities. Provide summary reports and metrics to the OHRS director and DFCI leadership upon request.
    • Coordinate and oversee institutional responsibilities outlined in the agreements and/or dictated by federal, state or local laws and policies. This may include, but is not limited to, verifying training of the research team, reviewing consent forms for local context, reviewing financial disclosures for conflicts of interest, ensuring local ancillary reviews are completed, reviewing reports of unanticipated problems or suspected noncompliance.
    • Perform administrative review of and processing of IRB submissions for research where the DFCI IRB is serving as the single IRB for external sites.
    • Develop policies, procedures, and tools to facilitate and streamline the reliance agreement review process, local submissions, and the performance of institutional responsibilities and local review.
    • Develop sIRB guidance documents, educational tools and templates for the DF/HCC research community. Conduct training of investigators and research staff on the use of sIRBs.
    • Ensure all DFCI sIRB policies, procedures, and documentation satisfy federal, state, and local regulations as well as Association for the Accreditation of Human Research Protection Programs (AAHRPP) accreditation requirements. Oversee and participate in quality assurance activities to assure compliance.

    Qualifications

    MINIMUM JOB QUALIFICATIONS:

    • Bachelors of Arts or Science required.
    • 3+ years experience in an IRB office or in a role that facilitates or oversees IRB review. Experience in an academic medical center preferred. Experience with single or central IRB administration strongly preferred.
    • Certification or eligibility to sit for Certification Exam for Certified IRB Professional (PRIM&R).
    • Excellent English language reading, writing, and speaking skills required.

    KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

    • Detailed knowledge of federal, state, and local regulations and an in-depth understanding of ethical principles regarding the protection of human subjects in research. Working knowledge of local and federal regulations for human subjects’ research (ICH-GCP, OHRP, FDA regulations).
    • Excellent customer service, project management, and process improvement skills. Ability to take initiative, prioritize tasks to meet deadlines, and produce results.
    • Excellent organizational and analytical skills and the ability to balance multiple priorities while maintaining a high level of accuracy and attention to detail.
    • An ability to exercise professional judgment related to sensitive, confidential, and regulatory matters and take initiative in the collection of information from a wide variety of sources. An ability to identify and independently resolve issues.
    • Excellent oral and written communication skills. Must effectively communicate with all levels of the organization and exhibit good presentation and training skills.
    • Proficient computer skills (MS Office, Adobe, DF/HCC CTMS and PRMS systems).
    • Develop and maintain advanced knowledge of federal regulatory requirements and institutional policies and procedures. Ability to interpret, analyze and explain complex policies, procedures, regulations for human subjects research.
    • Ability to learn or knowledge of scientific and medical concepts and terminology related to oncology research involving human subjects.

    SUPERVISORY RESPONSIBILITIES: None

    PATIENT CONTACT: None

     

    Located in Boston and the surrounding communities, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow's physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

     

    Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.

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