Careers in Quality

The Assistant Director, Expedited Review assists the Human Research Office (HRO) Director in facilitating the human research protection program in accordance with federal and state requirements, HRO policies and procedures and accreditation standards. The incumbent is responsible for general oversight of research reviewed via expedited procedures, managing Expedited Specialists, serving as a liaison and providing education to the research community. Reports directly to the HRO Director.

PRINCIPAL DUTIES AND RESPONSIBILITIES:    
1.    Oversees and manages a team of Expedited Specialists responsible for expedited review of minimal risk research, exempt determinations, and decisions as to whether activities meet the definition of human subject research or clinical investigations.  
2.    Responsible for development and implementation of initial and ongoing training and support of assigned staff and acts as resource for regulatory issues and institutional policies and procedures.
3.    Develops, maintains, and enforces standard operating procedures to improve efficiency, effectiveness, and regulatory compliance.
4.    Hires and develops assigned staff through ongoing coaching, counseling, and training; sets performance standards and evaluates performance annually; takes corrective action when needed.
5.    With Director and others, assesses review turnaround and outcomes; identifies opportunities for improvement; leads and participates in process improvement activities; implements changes and measurements for success.
6.    With Director and others, participates in human subject protection program evaluation and strategic planning and formulation of short- and long-term goals and objectives.
7.    With Director and others, develops and oversees implementation of human research protection educational programs for IRB members, investigators, and research staff.
8.    As needed, attends convened meetings of the IRB, reviewing and voting on protocols, providing regulatory guidance to members.
9.    Keeps current on federal, state, local laws and regulations pertaining to human subject protection through attendance at institutional workshops, seminars, and conferences on human subject research
10.    Interacts with regulatory agencies as needed on matters related to institutional policies and procedures and regulatory compliance 
11.    Support and participate in IRB initiatives on diversity, equity, and inclusion (DEI) and translation into improved health care in our community.
12.    Other duties as assigned.

QUALIFICATIONS:  
1.    Master’s degree in a related field (e.g. Nursing, Master of Science, Physician’s Assistant) or Bachelor’s degree and 10+ years of IRB administration experience.
2.    Extensive knowledge of federal, state, and local laws and regulations governing human-subjects research.
3.    Certified IRB Professional (CIP) required.

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:    
1.    Excellent oral and written communication skills.
2.    Excellent organizational skills.
3.    Excellent interpersonal skills.
4.    Excellent managerial skills

WORKING CONDITIONS:   
Remote position with possible occasional travel to Mass General Brigham for office-wide meetings or retreats. 

SUPERVISORY RESPONSIBILITY:  

Directly supervises employees (10-12 direct reports)

FISCAL RESPONSIBILITY:  
Demonstrates fiscal responsibility by effectively using Mass General Brigham resources; no direct budgetary responsibility