Senior IRB Compliance Specialist for Biomedical Research

Location
Fairfax, VA
Salary
Commensurate with education and experience.
Posted
Nov 23, 2021
Closes
Dec 13, 2021
Ref
STF10659
Industry
Education
Hours
Full Time
Senior IRB Compliance Specialist for Biomedical Research

The George Mason University Office of Research Integrity and Assurance (ORIA) invites applications for a Senior IRB (Institutional Review Board) Compliance Specialist to specialize in the review of Biomedical research studies.

George Mason University has a strong institutional commitment to the achievement of excellence and diversity among its faculty and staff, and strongly encourages candidates to apply who will enrich Mason's academic and culturally inclusive environment.

Responsibilities:


The primary responsibilities of the Senior IRB Compliance Specialist for Biomedical research include the following:

  1. Performing analysis of protocols, focusing mainly on Biomedical protocol submissions, to review for completeness and compliance with regulations and IRB policies and procedures;
  2. Determining whether the protocol constitutes human subjects research, assigning the appropriate category under federal guidelines; and
  3. Either performing the evaluation, sending the protocol to a board member for expedited review, or recommending that it be reviewed by the full board.

The Senior IRB Compliance Specialist for Biomedical research determines the most expeditious processing mechanism allowed for an application based on an understanding of the proposed research and an interpretation of appropriate guidelines, including DHHS, FDA and other applicable regulations. In addition, the Senior IRB Compliance Specialist for Biomedical research attends monthly IRB meetings and provides technical support and guidance on regulatory matters; assists with writing highly detailed meeting minutes to outline the issues analyzed by the committee, and accurately documents the final determinations of the IRB. The Senior IRB Compliance Specialist for Biomedical research also composes clear, concise and detailed correspondence to investigators to ensure that the concerns, rationale and technical questions of the IRB are quickly and intelligibly communicated to the researchers; conducts evaluation of investigator's response to identify potential issues for IRB reviewers; determines when IRB requirements for approval have been met and issues approval documents. The Senior IRB Specialist for Biomedical research maintains accurate electronic IRB files; assists in creating meeting agendas and with meeting material preparation; meets with investigators and research staff to advise them on federal regulations and IRB submission requirements and assists them as needed in the preparation of submission forms; and conducts educational IRB classroom presentations as needed. The Senior IRB Specialist for Biomedical research will also act as the Protocol Registration and Results System (PRS) administrator for ClinicalTrials.gov and will provide assistance to researchers who post their research studies to ClinicalTrials.gov. This position will be responsible mainly for reviewing projects involving biomedical research procedures, but will also assist with social behavioral protocols as needed.

Required Qualifications:


  • Bachelor's degree or equivalent education and experience;
  • Experience reviewing biomedical IRB protocols;
  • Excellent writing skills are needed to generate clear, precise, detailed and grammatically correct technical letters, memos and reports;
  • Exceptional analytical ability is necessary in order to apply knowledge of federal regulations and institutional policy to research proposals;
  • Superior organizational skills and attention to detail are required in order to effectively and efficiently manage multiple priorities and a high-volume workload;
  • Strong interpersonal and communication skills with a capacity to work well with multiple constituencies of various educational and social backgrounds;
  • Proficiency in the use of multimedia hardware and software applications including the use of MS Windows, database, spreadsheet and word processing and be familiar with online protocol submission systems;
  • Must have the ability to make accurate and appropriate independent judgments, but be able to accept direct supervision and know when to refer issues to supervisor; and
  • Ability to pass CIP certification exam in first year of employment.


Preferred Qualifications:


  • Experience applying FDA regulations;
  • Experience reviewing clinical trials;
  • Familiarity with the ClinicalTrials.gov PRS system;
  • Current CIP certification; and
  • Experience with IRB reliance agreements/single IRB reviews.


Candidates must be one of the following:

  • A citizen of the United States;
  • A person who is a lawful permanent resident of the United States (a "Green Card" holder);
  • A person who is a "protected individual" as defined by 8 U.S.C. 1324b(a) (3); or
  • A person who is otherwise able to become generally eligible to receive unclassified technical data pursuant to the International Traffic in Arms Regulations.


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For full consideration, applicants must apply at https://jobs.gmu.edu/ ; complete and submit the online application; and upload a cover letter, resume, and a list of three professional references with contact information.
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Great Careers Begin at Mason!

George Mason University is an innovative, entrepreneurial institution with national distinction in both academics and research. Mason holds a top U.S. News and World Report "Up and Coming" spot for national universities and is recognized for its global appeal and excellence in higher education.

Mason is currently the largest and most diverse university in Virginia with students and faculty from all 50 states and over 135 countries studying in over 200 degree programs at campuses in Arlington, Fairfax and Prince William, as well as at learning locations across the commonwealth. Rooted in Mason's diversity is a campus culture that is both rewarding and exciting, work that is meaningful, and opportunities to both collaborate and create.

If you are interested in joining the Mason family take a look at our current opportunities and catch some Mason spirit at jobs.gmu.edu/!

George Mason University, Where Innovation is Tradition.

New hires starting after August 15, 2021, must have received at least one COVID-19 vaccination by their start date, be fully vaccinated within 45 days of their start date, and submit documentary proof unless they have an approved medical or religious exemption by their start date. For updated George Mason University COVID-19 vaccination requirements, please visit George Mason University Vaccination Requirements .
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George Mason University is an equal opportunity/affirmative action employer, committed to promoting inclusion and equity in its community. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any characteristic protected by law.

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