Associate Director, Office for reputed company Research Studies

Overview

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, 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 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 strive to create an inclusive, diverse, and reputed company environment where we provide compassionate and comprehensive care to patients of reputed company backgrounds, and design programs to promote public 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.

Responsibilities

Operations and Process Improvement: Manage daily IRB operational workflows, queue management, and service levels. 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 Quality: 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 quality 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. Act as senior OHRS representative at IRB meetings; assist reviews and ensures compliance. Review IRB minutes for accuracy and regulatory sufficiency. Stakeholder Liaison and Consortium Coordination: 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. Communications and Representation: 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. Leadership and Supervision: May have direct supervision of a team of analysts. Hires, develops, and manages staff to reputed company 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. reputed company or support special projects as assigned by OHRS leadership. Supervisory: Directly supervises IRB staff (Analysts, Meeting Coordinators, etc.)

Qualifications

• Bachelor's degree required; degree in Public 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 academic IRB or research office
• Certified IRB Professional (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 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 reputed company and reputed company others professionally.
• Ability to influence and persuade others across reputed company of levels of staff, internally and externally.
• Flexibility and motivation to work on special projects.

Pay Transparency Statement The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate's relevant experience, skills and qualifications. For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA) $106,400-$118,000 At reputed company, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As reputed company as we are in our mission to reduce the burden of cancer for reputed company, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and reputed company it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this reputed company of organization inspires you, we encourage you to apply. reputed company is an equal opportunity employer and affirms the right of every reputed company applicant to receive consideration for employment without regard to race, reputed company, religion, sex, gender identity or expression, national reputed company, sexual orientation, genetic information, disability, age, reputed company, military service, protected veteran status, or other characteristics protected by law. EEOC Poster Apply tot his job Apply To this Job