Sr. Human Subject Research Protection Coordinator

About the Opportunity

Job Duties:
The Sr Coordinator assists in the operational management of human subject research activities, manages the confidential institutional review and approval process for research activities, and ensures participants’ safety, rights, and welfare. The coordinator provides administrative support to the IRB providing training and the necessary resources to complete reviews; ensure rosters are current, accurate and comply with federal regulations; prepares reports, drafts minutes, share with appropriate parties and ensures appropriate document management.

Job Responsibilities:
40% - Operational Management 

• Ensures that unit’s operations meet legal and regulatory requirements and are in compliance with complex federal, state, and local regulations regarding the activities of the IRB. 
• Disseminates information about and assists investigators in the preparation of complex IRB applications to ensure that required elements have been addressed. 
• Monitors changes in laws, regulations, and technology and advises management how changes may impact current operations.  
• Serves as a subject matter expert for inquiries from campus faculty members, investigators and students regarding IRB policies, procedures, and processes.  
• Collaborates  research teams in addressing complex and challenging research initiatives new to NU.

40% IRB Management

• Reviews request to amend or modify approved protocols and makes determination about which requests require full IRB review and which can be reviewed using an expedited process. 
• Prepares IRB meeting agenda and assigns protocol reviews based on subject matter knowledge and the expertise/role of each panel member. 
• Responsible for ensuring compliance with quorum and voting requirements for all IRB approvals deliberated at convened meetings.
• Drafts IRB deliberation and stipulations and effectively communicates these to the PI and members of the research team. 
• Prepares and distributes reports of expedited reviews and IRB minutes.
• Assists in the training of appropriate personnel to be IRB committee members and assigns them to review specific protocol submissions based on the appropriateness of their scientific expertise and experience as an IRB member. 
• Maintains current IRB rosters and maintain IRB member files.
• Ensures FWA and other federal registrations are current and accurate.
• Serves as a voting member on minimal risk research and as an alternative voting member for some full board research.

20% Other Duties as Assigned

• Ability to prioritize and coordinate multiple tasks; organize communications and reports, and meet deadlines.
• Ability to meet or exceed customer service needs and expectations and provide excellent customer service at a working level of proficiency and within unit expectations.
• Provides backup to the Executive Director & Assistant Director with regard to IRB process and special projects.
• Represents the unit in committees when issues and concerns regarding administration of human research subjects are involved. 
• Engages in continuing professional development activities to improve knowledge of technical and ethical aspects of human subject research.
• Performs other duties and responsibilities as assigned.

Job Qualifications

• A minimum of 2 years of experience conducting and/or monitoring research involving human participants, or in a related administrative role supporting federally regulated human subject's research 
• Experience in the management of operational activities in a demanding, research extensive (R1) university. 
• Demonstrated ability to interpret and apply university, state, and federal regulations and policies as they pertain to human subject research.
• Demonstrated ability to perform effectively, both independently and as a team member, with a professional demeanor in a diverse and fast-paced work environment consisting of multiple and changing priorities, under minimal supervision.
• Demonstrated ability to incorporate knowledge gained from continuing professional development opportunities. 

Education

• Bachelor’s degree required in a scientific, social science, or humanities discipline. Alternate degree fields will be considered/accepted based upon the nature and depth of the experience as it relates to this position.
• Meets eligibility requirements to obtain CIP certification within one year of hire. 

Position Type

Research

Additional Information

Northeastern University considers factors such as candidate work experience, education and skills when extending an offer.  

Northeastern has a