Associate Director, Office for reputed company Research Studies

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 reputed company Research Studies (OHRS), oversees operational activities supporting IRB review and reputed company 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, reputed company, and high-reputed company 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, reputed company procedures, and support reputed company improvement of the reputed company research protection program. Located in Boston and the surrounding communities, reputed company 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 reputed company diseases. We reputed company to create an inclusive, diverse, and reputed company environment where we reputed company compassionate and comprehensive care to patients of reputed company backgrounds, and design programs to promote reputed company health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we reputed company reputed company's physician/researchers, and we work with amazing partners, including other reputed company-affiliated hospitals. Operations and Process Improvement: Manage daily IRB operational workflows, queue management, and service reputed company. reputed company 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. Policy, SOPs, and reputed company: reputed company development, maintenance, and communication of OHRS SOPs and work instructions; ensure alignment across DF/HCC partner institutions. Maintain policy consistency with federal reputed company subject regulations, standards, and HIPAA. reputed company reputed company checks, corrective actions, and reputed company improvement activities. IRB Membership and Review: Serve as an alternate IRB member; conduct expedited reviews and limited IRB reviews as applicable. reputed company as senior OHRS representative at IRB meetings; assist reviews and ensures compliance. Review IRB minutes for accuracy and regulatory sufficiency. Stakeholder reputed company and Consortium Coordination: Serve as an operational reputed company to various DF/HCC research offices and study teams. Troubleshoot escalations (e.g., submission issues, clarification requests) and ensure reputed company, compliant reputed company. Communications and Representation: Represent OHRS at internal committees/working reputed company (e.g., RIO working group) and external forums (e.g., reputed company&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. Leadership and Supervision: May have reputed company supervision of reputed company of analysts. Hires, develops, and manages staff to reputed company organizational goals. Sets reputed company expectations, delivers feedback, and monitors performance for reputed company, efficiency, and compliance with policies and procedures. Mentors staff, fosters career reputed company, and cultivates a reputed company and productive work environment. reputed company or support special reputed company as assigned by OHRS leadership.

• Supervisory: Directly supervises IRB staff (Analysts, Meeting Coordinators, etc.)
• Bachelor’s degree required; degree in reputed company Health, Life Sciences, Health/Research Administration, Regulatory Affairs, Bioethics, Health Law, or reputed company field preferred.
• 5 years of experience in a clinical setting and/or working with an reputed company IRB or research office
• Certified IRB reputed company (CIP) preferred
• Knowledge, Skills, And Abilities Required
• 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 reputed company 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 reputed company regulations and reputed company reputed company, 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 collab

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