IRB Compliance Specialist

2 weeks ago

Marlborough, Massachusetts, United States TALENT Software Services Full time

Are you a skilled Institutional Review Board (IRB) Compliance Specialist looking to advance your career? Talent Software Services is currently seeking a qualified IRB Compliance Specialist to join a reputable organization.

Position Overview: The organization is in search of seasoned IRB professionals dedicated to upholding the integrity of human research and safeguarding the rights of research participants. The primary objective of the IRB is to ensure the protection of the rights, privacy, and welfare of all individuals involved in research initiatives conducted by the organization and its associated faculty, staff, and students. Alongside participant protection, the aim is to deliver exceptional service to support the research process.

Key Responsibilities:

  • The IRB Compliance Specialist will manage a portfolio of applications submitted for IRB evaluation, demonstrating sound judgment and strong analytical, organizational, and time management abilities.
  • Act as a vital liaison and expert resource for the research community, including principal investigators and study personnel, while being well-versed in federal and state regulations governing human subject research, as well as relevant institutional policies and procedures. Continuously interpret and apply these requirements to research proposals and ongoing studies, conducting thorough analyses of all submissions for IRB review.
  • Assess completeness, accuracy, and the necessary level of review for all submissions.
  • Utilize strong organizational and teamwork skills to handle a high volume of submissions, meet deadlines, and manage stakeholder expectations; perform critical reviews of submissions, seek clarifications or modifications from researchers, and make independent decisions or provide recommendations to the convened IRB.
  • Serve as a voting member of the convened IRB and as a designated Expedited Reviewer to assess and approve non-exempt minimal risk research through expedited review processes; offer technical support and guidance on regulatory matters during IRB meetings; conduct expedited reviews, document findings specific to applications, and generate notifications regarding review outcomes.
  • Exercise authority to determine non-human subjects research and exempt status; conduct evaluations of investigator responses to identify potential issues for IRB reviewers and advise on whether the criteria for IRB approval have been satisfied. Collaborate with IRB Chairs to manage pre-meeting, meeting, and post-meeting activities of the convened IRB, including agenda management and meeting facilitation.
  • Provide guidance to IRB Administrative Assistants to enhance the efficiency and effectiveness of IRB operations, and draft, edit, and prepare correspondence and notification letters using databases.
  • Participate in the orientation and training of IRB personnel, including peers, and assist in onboarding new IRB members while actively engaging in the training of new non-scientific IRB members and participating in IRB-related quality and educational initiatives as necessary.
  • Recruitment efforts are focused on fulfilling an upcoming need for an IRB specialist with a single IRB/reliance emphasis.
  • Preference will be given to candidates with substantial experience in either of the following areas:
    • Single IRB (sIRB) review for multi-center research when mandated, or
    • Direct experience within organizational IRB operations and all associated policies, procedures, and practices.

Qualifications:

  • A Bachelor's degree is required, preferably in natural and social sciences, nursing, management, or another health-related field, along with a minimum of 2 years of experience in human subjects research.
  • Alternatively, candidates with an Associate's degree and 6 years of experience in human subjects research may be considered.
  • Ability to efficiently manage a substantial volume of items while maintaining a high level of accuracy and attention to detail.
  • Strong organizational and decision-making skills, with the capability to evaluate and critique multiple issues, as well as the analytical skills necessary to apply knowledge of federal regulations and institutional policies to various complex situations and research protocols.
  • Excellent interpersonal skills are essential for interacting with a diverse range of individuals involved in human subject research.
  • Effective communication skills are required to engage with team members and others positively; utilize these skills to facilitate convened IRB meetings.
  • Ability to meet production targets within established time and quality standards is essential; proficiency in multimedia hardware and software applications, including Windows, databases, spreadsheets, and word processing, is required.

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