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IRB Specialist

Brown University – Providence, RI

Brown Universitys Institutional Review Board (IRB) is charged with ensuring that all aspects of human subjects research comply with applicable laws, federal regulations, and institutional policies. Under the direction of the Associate Director of the Human Research Protection Program (HRPP), the IRB Specialist is responsible for the daily administration, implementation, and management of policies and procedures related to the conduct of human subjects research projects at Brown University. He/she will also provide administrative and regulatory support to Browns Human Embryonic Stem Cell Research Oversight (ESCRO) committee.

Major Responsibility: Management of human subject research / embryonic stem cell research questions from the Brown University research community 40%

Supporting Actions:

  • The IRB Specialist will serve as the primary contact for all incoming queries related to Browns Human Research Protection Program (HRPP) and ESCRO committee policies and procedures, and the conduct of human research in compliance with the governing regulations.
  • He/she will independently assess and promptly respond to a very high volume of questions received from investigators and administrators via phone and email. The IRB Specialist will consistently update Frequently Asked Questions (FAQs) responsive to repeat inquiries from the research community and ensure the FAQs are revised and updated in accordance with changing needs and regulatory requirements.
  • The IRB Specialist will develop, implement and manage innovative methods and systems to support the research community and enable quick access to the HRPP for questions and answers.
  • The IRB Specialist will serve as the primary point-of-contact for questions about use of the InfoEd protocol submission and review system, and will coordinate with the Research Administration Information Systems (RAIS) team to trouble-shoot any issues

Major Responsibility: Management of IRB protocol submissions & support of the IRB and ESCRO committee 40%

Supporting Actions:

  • The IRB Specialist will conduct intake reviews of new protocols, amendments and annual progress reports and will make an initial assessment of appropriate level of review (e.g., full board, expedited, exempt, non-human subjects) based on prospective risk to participants. He/she will contact the investigator and request additions or corrections as needed, and triage submissions to team members when they fall outside his/her own portfolio.
  • The IRB Specialist will independently apply regulatory requirements and Brown policies to conduct review of Human Subject Research determination form submissions, progress reports, exempt protocol submissions, and Undergraduate Student projects involving human subjects. He/she will work directly with investigators and research support staff to ensure that all submissions are complete and compliant, and will ensure that approvals/reviews are conducted in an expeditious manner.
  • The IRB Specialist will be responsible for monitoring research personnel compliance with requisite CITI training, conflict of interest disclosures, and will perform other ongoing compliance checks as needed. He/she will provide ongoing support to the IRB, including, but not limited to, preparatory tasks for meetings and recording of meeting minutes.
  • The IRB Specialist will provide administrative support to the ESCRO committee, including answering questions for investigators, maintaining website content, preparing materials for the committee, and staying abreast of regulatory requirements.
  • The IRB Specialist will maintain primary responsibility for developing, revising, and managing the various forms required for submission. He/she will anticipate the need for changes and updates to existing forms, and will proactively recommend implementation of new forms.

Major Responsibility: Education & Outreach 20%

Supporting Actions:

  • The IRB Specialist will take initiative to develop educational, regulatory resources for the Brown University human research community through strategic management of and content development for the HRPP website.
  • The IRB Specialist will monitor changes to regulations in combination with the evolving needs of Browns research community to propose new policies, procedures, and training opportunities. He/she will coordinate outreach and educational opportunities with researchers, help develop and independently manage online training opportunities, and build the HRPPs online training library.
  • The IRB Specialist will provide hands-on training and support for the electronic IRB system, InfoEd.
  • The IRB Specialist will create and maintain regulatory compliance training pertaining to the use of human embryonic stem cells in research at Brown.

Decisions Position is Free to Make

  • Evaluate whether a project meets the definition of human subjects research or meets exempt review criteria.
  • Determine appropriate type of review (based on risk) for human research protocols, which may override an investigators preliminary determination. Evaluate investigator compliance with committee requests and, if adequate, permit research to begin.
  • Determine when and what to provide during the course of an IRB meeting, (e.g., regulatory or background information), in order to facilitate the discussion and review of a protocol.
  • Determine adequate content of meeting minutes to meet regulatory requirements.

Dimensions

  • The HRPP has approximately 900 active protocols from 500 unique investigators.
  • The HRPPs submission volume averages approximately 50 submissions (of various types) per calendar month.
  • The HRPP email inbox volume is exceptionally high. On average, approximately 20-25 new emails are received each day which require prompt attention and analysis and response by the IRB Specialist.

Job Qualifications and Competencies

Education

  • Required: Bachelors degree or 3-5 years working in a relevant field (biomedical and/or behavioral research, working with federal and state regulations in a higher education setting)
  • Preferred: Certified IRB Professional (CIP) or other professional training certification preferred. CIP eligibility within two years of hire required.

Experience

  • Experience working in a human research protection program and knowledge and understanding of human subject research regulations and federal policies desirable. Demonstrated ability with interpretation of regulations, laws, bills and statutes that impact biomedical/behavioral research environments.
  • Excellent interpersonal and organizational skills, strong problem-solving skills, ability to prioritize competing demands, meet deadlines in a fast-paced environment, multitask effectively, work independently and work interdependently.
  • Excellent computer skills with proficiency in Microsoft Office; precision and accuracy in data entry and written communications; exceptional oral and written communication skills are required.
  • The IRB Specialist must be able to collaborate with individuals at all different levels of the organization with a high level of diplomacy and professionalism and handle confidential information with discretion.
  • The IRB Specialist would be expected to work in the office most days due to the nature of the position, particularly the requirement to answer a high volume of incoming phone calls, interact with office visitors, and collaborate frequently with IRB Managers.
  • Compliance in the two regulatory areas (human subject research, embryonic stem cell research) is of critical importance to Brown; non-compliance could result in undue harm or risk to research participants and employees, and reputational and financial risk to the institution.

Criminal background and educational check

Recruiting Start Date:

2019-06-17-07:00

Job Posting Title:

IRB Specialist

Department:

Office of Research Integrity

Grade:

Grade 9

Worker Type:

Employee

Worker Sub-Type :

Regular

Time Type:

Full time

Scheduled Weekly Hours:

37.5

Submission Guidelines:

Please note that in order to be considered an applicant for any staff position at Brown University you must submit an application form for each position for which you believe you are qualified. Applications are not kept on file for future positions. Please include a cover letter and resume with each position application.

Still Have Questions?

If you have any questions you may contact [email protected] .

EEO Statement:

Brown University is an E-Verify Employer.

Brown University is committed to fostering a diverse and inclusive academic global community; as an EEO/AA employer, Brown considers applicants for employment without regard to, and does not discriminate on the basis of, gender, sex, sexual orientation, gender identity, national origin, age, race, protected veteran status, disability, or any other legally protected status.

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