Associate Director, Office for Human Research Studies

About the position This position's work location is fully remote. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI). The Associate Director, Office for Human Research Studies (OHRS), oversees operational activities supporting IRB review and human research protections across the Dana-Farber/Harvard Cancer Center (DF/HCC) consortium. Works with the Director to implement operational priorities and execute goals. Manages IRB analyst workflows, process improvements, and SOP/policy governance to ensure compliant, timely, and high-quality protocol review. Serving as an alternate IRB member, conducts expedited reviews in accordance with federal regulations and institutional policies. Partners with clinical research offices across DF/HCC institutions to resolve operational issues, align procedures, and support continuous improvement of the human research protection program. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

Responsibilities

• Manage daily IRB operational workflows, queue management, and service levels.
• Develop and maintain training materials and work instructions.
• Identify and implement process and systems improvements using metrics and stakeholder feedback, coordinating with the Director to ensure consistency across the DF/HCC consortium.
• Lead development, maintenance, and communication of OHRS SOPs and work instructions; ensure alignment across DF/HCC partner institutions.
• Maintain policy consistency with federal human subject regulations, standards, and HIPAA.
• Oversee quality checks, corrective actions, and continuous improvement activities.
• Serve as an alternate IRB member; conduct expedited reviews and limited IRB reviews as applicable.
• Act as senior OHRS representative at IRB meetings; assist reviews and ensures compliance.
• Review IRB minutes for accuracy and regulatory sufficiency.
• Serve as an operational liaison to various DF/HCC research offices and study teams.
• Troubleshoot escalations (e.g., submission issues, clarification requests) and ensure timely, compliant resolution.
• Represent OHRS at internal committees/working groups (e.g., RIO working group) and external forums (e.g., PRIM&R, AAHRPP).
• Communicate with clinical trial offices across the five Harvard institutions (e.g., BIDMC CCTO, MGH CCPO, DFCI CTO).
• Translate regulatory updates into operational guidance for investigators and staff.
• May have direct supervision of a team of analysts.
• Hires, develops, and manages staff to achieve organizational goals.
• Sets clear expectations, delivers feedback, and monitors performance for quality, efficiency, and compliance with policies and procedures.
• Mentors staff, fosters career growth, and cultivates a positive and productive work environment.
• Lead or support special projects as assigned by OHRS leadership.

Requirements

• Bachelor's degree required; degree in Public Health, Life Sciences, Health/Research Administration, Regulatory Affairs, Bioethics, Health Law, or related field preferred.
• 5 years of experience in a clinical setting and/or working with an academic IRB or research office
• Demonstrated expertise in application of federal regulations to clinical research.
• Demonstrated knowledge of HIPAA regulations as they relate to clinical research.
• In-depth knowledge of Federal, state, and local regulatory information regarding the protection of human subjects in biomedical research.
• Strong written and verbal communication skills necessary to allow productive communication between OHRS, DF/HCC Leadership, Investigators and other research personnel.
• Ability to interpret complex regulations and provide sound, practical guidance to investigators and staff.
• Problem solving, decision-making and analytical skills necessary to identify problems and proposed solutions and the ability to implement solutions.
• Ability to work independently and collaboratively in a matrixed, multi-institution environment
• Strong ability to lead and develop others professionally.
• Ability to influence and persuade others across all of levels of staff, internally and externally.
• Flexibility and motivation to work on special projects.

Nice-to-haves

• Certified IRB Professional (CIP) preferred

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