Research Compliance Specialist

5 days ago

Waltham, Massachusetts, United States Brandeis University Full time

Are you passionate about protecting human subjects and ensuring the integrity of research?

About the Role

We are seeking a highly skilled and detail-oriented Research Compliance Specialist to join our Human Research Protection Program team at Brandeis University.

Job Description

This is a part-time position working 17.5 hours per week. The Research Compliance Specialist will be responsible for:

  • Protocol Support & Review (70%)
    • Conduct preliminary reviews of protocol submission materials to identify areas of risk to human subjects, ensure consistency in the application, completeness, conflicts of interest, and compliance with all regulatory standards and institutional requirements.
    • In collaboration with other members of the HRPP team, respond to incoming emails, phone calls, walk-in visits, and scheduled appointments with researchers to answer all questions, and triage toward appropriate resources.
    • In collaboration with HRPP leadership, as needed, advise faculty and other researchers on issues of ethical research, responsible conduct of research, and research compliance.
    • Facilitate the review process; conduct exempt determinations in the office, if qualified through experience and expertise; manage expedited reviews with IRB members and reviews with the Full Board.
    • Thoroughly review reliance agreements, individual investigator agreements, and ceding memos to ensure alignment with institutional policies and regulatory requirements.
  • Program Management & IRB Operations (30%)
    • Post Approval Monitoring: work with HRPP leadership, IRB Chair, and other stakeholders to support the execution of post approval monitoring program. Supports the processes for conducting PAM activities (forms, procedures, communications).
    • Information Systems & Records Management: supports the maintenance of the electronic filing system, assigns and tracks protocols through the review process, prepares and sends notifications and documents relating to the review and approval process, communicates with the IRB and board members, as needed.
    • Outreach & Education: actively builds relationships with all members of the HSR community to become a trusted partner in the research process and contribute to the culture of compliance at Brandeis University.
    • IRB Support: supports the development of meeting agendas, schedules, assists in preparing board meeting materials, preparation of minutes according to regulatory standards, assists the Associate Director with Membership management, and tracks quorum at meetings.
    • General Support: collaborates and participates in onboarding activities of new staff members and IRB members, identifies administrative processes or compliance issues that need to be addressed and offers ideas and recommendations for solutions.
Requirements

To be considered for this role, you must have:

  • A Bachelor's degree required; Master's degree preferred.
  • 1-3 years of related work experience, with a preference to direct experience in an HRPP Office, research administration office, or other research-adjacent role.
  • Some familiarity with regulations pertaining to the protection of human subjects, including HHS, FDA, and HIPAA; research ethics and methods, particularly those in the social sciences including anthropology, sociology, psychology, and marketing.
  • High proficiency in Microsoft Office Programs: Word, Excel, PowerPoint; Google Suite Programs: Gmail, GoogleDocs, Google Sheets, Google Forms, etc.; Internet Functions; Adobe Professional.
What We Offer

As a member of our team, you can expect:

  • A competitive salary range: $55,000-$65,000 per year.
  • A comprehensive benefits package, including medical, dental, and life insurance.
  • Tuition benefits for employees, dependents, and spouses.
  • A generous 403b retirement savings plan match.
  • The opportunity to work in a dynamic and inclusive environment with a commitment to diversity, equity, and inclusion.

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