Position Description

Part-Time Human Subject Research Manager
Location United States
Department Other Programs R&D
# of openings 1
Apply Now

Vital Strategies, headquartered in New York City, is an international public health organization. Our programs strengthen public health systems and address the world’s leading causes of illness, injury and death. We currently work in 73 countries, supporting data-driven decision making in government, advancing evidence-based public health policies and mounting strategic communication campaigns. Vital Strategies’ priorities are driven by the greatest potential to improve and save lives. They include non-communicable disease prevention, cardiovascular health promotion, tobacco control, road safety, obesity prevention, epidemic prevention, environmental health, vital statistics systems building and multi-drug resistant tuberculosis treatment research. Our programs are concentrated in low- and middle-income countries and cities in Africa, Latin America, Asia and the Pacific. Please visit our website at www.vitalstrategies.org to find out more about our work.

Vital Strategies offers highly competitive compensation and comprehensive benefits. Vital welcomes and supports a diverse, inclusive work environment. As such, our commitment is to promote equal employment opportunities (EEO) for all applicants seeking employment.

The Position:

Vital Strategies is committed to conducting its human subjects research activities in compliance with highest ethical standards and maintains a Federalwide Assurance. We are seeking a qualified candidate for the position of part-time Human Subjects Research Manager (2 days weekly) who will be responsible for monitoring the organization’s compliance with applicable laws and the FWA, including through development of SOPs, regular reviews of the organization’s research portfolio and liaising with the organization’s legal department to develop standard legal provisions for subgrantees/service providers.  He/she will also serve as an internal advisor for program teams with respect to US and local IRB submissions and other research-related compliance questions.

This is a remote working position and can be based in the following states:  New York, New Jersey, Connecticut, D.C., Maryland, Virginia and North Carolina.  This is an exempt position with a salary range of $73,600 to $85,866 (equivalent of $29,440 to $34,346 for part-time 2 days weekly).

Applicants in the U.S. must possess valid work authorization to work in the U.S. at the time of hire. 

Specific Duties and Responsibilities:

  • Oversee Vital Strategies’ system for ensuring compliance with relevant laws and standard operating procedures (SOPs) related to protecting human subjects in research activities

  • Carry-out the functions of the HPA as described in Vital Strategies’ Human Subjects Research (HSR) Policy and SOPs which include:

    • Monitoring for changes in applicable laws and regulations to ensure HSR SOPs remain up to date

    • Drafting updates of the HSR SOPs as needed, in consultation with and for the approval of the Research Subcommittee

    • Developing and conducting training of staff and consultants, as required, and tracking compliance with training requirements

    • Maintaining and supporting the relationship with Vital Strategies’ preferred US IRB(s)

    • Providing Vital Strategies program staff and management with support and guidance when applying Vital Strategies HSR Policy and SOPs and when making submissions to IRBs

    • Evaluating use of IRBs other than the preferred US IRB(s) that are proposed by Vital Strategies programs to review HSR projects

    • Maintaining “Approved IRB” lists

    • Conducting periodic reviews of program activities to ensure compliance with Vital Strategies SOPs

    • Investigating and escalating instances of HSR non-compliance as and when required under the HSR SOPs and applicable laws

    • Maintaining in good standing Vital Strategies’ permissions/regulatory approvals w/r/t HSR, including the organization’s Federalwide Assurance (FWA) and relevant State certifications

    • Maintaining records of IRB determinations and reviews and of instances of non-compliance and making periodic reports to the Research Subcommittee on the same

    • Drafting guidance and resources, as needed, for Vital Strategies program staff and management to ensure compliance with Vital Strategies SOPs

Qualifications:

Education and Degree - 

  • B.A. or B.S. degree in a relevant field required

  • Masters or JD preferred

Skills and Abilities - 

  • Ability to analyze, interpret and communicate to non-experts, complex governmental regulations and guidelines.

  • Detailed working knowledge of human subjects research international guidelines (Declaration of Helsinki; Belmont Report) and the U.S. laws and regulations set forth in the Common Rule (45 CFR part 46), including OHRP regulations.

  • Self-motivated with excellent organizational skills.

  • Excellent oral and written communication skills.

  • Advance Microsoft Office skills including Word, Excel, and PowerPoint.

Professional Certification - 

  • Successful completion of CITI Human Subjects Research training and the Certified IRB Professional (CIP) exam.

Experience:

Required - 

  • At least 6 years prior experience in one or more of the following roles:  IRB administration or human protections administrator.

Back Apply Now