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Institutional Review Board

3 months ago

Marlborough, United States TALENT Software Services Full time

Are you an experienced Institutional Review Board (IRB) Specialist with a desire to excel? If so, then Talent Software Services may have the job for you Our client is seeking an experienced Institutional Review Board (IRB) Specialist to work at their company in Rochester, MN.


Position Summary: The client is seeking experienced IRB professionals to facilitate excellence in human research and the protection of research participants. The primary mission of the IRB is to ensure the protection of rights, privacy, and welfare of all human participants in research programs conducted by clients and associated faculty, professional staff, and students. Coexistent with participant protection is the goal of providing quality service to enhance the conduct of research.


Primary Responsibilities/Accountabilities:

  • The IRB Specialist is primarily responsible for the management of a caseload of applications submitted for IRB review and demonstrates sound judgment, as well as analytical, organizational, and time management skills.
  • Serves as a critical link between and is an expert resource for the client research community (principal investigators and other study personnel), the client's Office for Human Subjects Protection, and the Client IRB members; is knowledgeable about the federal and state regulations governing human subject research, and related institutional policies and procedures; continuously interprets and applies these requirements to human subject research proposals and ongoing research activities; performs a detailed analysis of all applications submitted for IRB review; manages the disposition of items submitted electronically for IRB review.
  • This includes assessments of completeness, accuracy, and level of review required.
  • Applies strong organizational skills and effective teamwork skills to manage a large volume of submissions, deadlines, and customer expectations; completes critical and comprehensive review of submissions, seeks clarification or alteration of the submission from Client researchers, and makes independent determinations or presents recommendations to the convened IRB.
  • Serves as a voting member of the convened IRB and a designated Expedited Reviewer to review and approve non-exempt minimal risk research using expedited review procedures; provides technical support and guidance on regulatory matters during convened IRB meetings; conducts expedited reviews, documents application-specific findings and generates investigator notifications regarding the outcome of the review.
  • Exercises the authority to make not-human subjects research and exempt determinations; responsible for conducting evaluations of investigator's response to identify potential issues for IRB reviewers and advise as to whether the requirements for IRB approval have been met. In partnership with the IRB Chairs, is responsible for managing the pre-meeting, meeting and post-meeting activities of the convened IRB.
  • This includes agenda management, and meeting facilitation and documentation.
  • Provides guidance to IRB Administrative Assistants, in support of efficiency and effectiveness of IRB operational activities and drafts, edits and prepares correspondence and notification letters using databases.
  • Participates in the orientation and training of IRB personnel, including peers.
  • Assists with the orientation of new IRB members and actively participates in the training of new nonscientific IRB members and participate in IRB-related quality and educational activities as needed.
  • Recruitment is dedicated to addressing an upcoming need for an IRB specialist with sIRB/reliance focus.
  • Candidates having substantive experience with either of the following will be considered with preference:
  • Single IRB (sIRB) review (when mandated) for multi-center research, or
  • Direct experience within client IRB operations and all related policies, procedures, and practices.


Qualifications:

  • Bachelor's degree required, preferably in the natural and social sciences, nursing, management or other health-related profession and at least 2 years experience in human subjects research.
  • Alternately, applicants with an Associate's degree and 6 years of experience in human subjects research may be considered.
  • Ability to efficiently manage a large volume of items while maintaining a high degree of accuracy and attention to detail
  • Strong organization and decision making skills, the ability to judge and critique multiple issues, and the analytical skills necessary to apply knowledge of federal regulations and institutional policy to variety of complex situations and research protocols;
  • Strong interpersonal skills are needed to interact with a wide variety of persons related to human subject research.
  • Ability to communicate with team members and others in a positive and effective manner; use effective communication skills to facilitate convened IRB meetings
  • Ability to meet production within established time and quality standards is required; be proficient in the use of multimedia hardware and software applications, including use of Windows, database, spreadsheets and word processing.