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Human Research Compliance Administrator

2 months ago

Worcester Massachusetts, United States University of Massachusetts Medical School Full time

Overview:

POSITION SUMMARY:


The Human Research Compliance Administrator ensures the effective and efficient adherence to research regulations and institutional policies regarding human subjects research.

This role involves reviewing research proposals involving human subjects, managing intricate compliance operations, and serving as a vital resource for the research community on compliance-related inquiries.


Responsibilities:

ESSENTIAL FUNCTIONS:

Compliance Administrator I:

Regulatory Review:
Identify relevant regulations and institutional policies for specific research submissions, evaluating for thoroughness and adherence.

Interpret and apply relevant regulations and policies to research submissions, exercising sound judgment in all evaluations.

Compliance Operations

Manage operational requests (e.g., reliance agreements), assess supporting documentation, and draft necessary correspondence.

Assist in designing and executing tests of submission processes.

Education and Training:
Collaborate with senior staff to create and implement training materials and educational initiatives related to compliance.

Evaluate incoming compliance inquiries and respond or direct them appropriately.

With appropriate oversight, provide guidance to the research community on compliance matters.

Non-essential functions:
Coordinate compliance events (room bookings, invitations/responses, etc.).

Update compliance-related web content, user accounts, etc.

Compliance Administrator II:

Regulatory Review:
Identify relevant regulations and policies for compliance submissions, evaluating for thoroughness and adherence.

Interpret and apply relevant regulations and policies to compliance submissions, exercising sound judgment in all evaluations.

Compliance Operations

Manage operational requests (e.g., reliance agreements), assess supporting documentation, and draft necessary correspondence.

Analyze and document processes and procedures.

Assist in designing and executing tests of submission processes.

Education and Training:
Educate and advise the research community on compliance matters.

Compliance Administrator III:
Compliance Operations


Oversee and direct the execution of agreements and memorandums of understanding (MOUs) with external institutions or investigators.

Design and execute tests of submission processes.

Education and Training:
Contribute to the development and implementation of training materials and educational initiatives.

Provide advice, guidance, and problem resolution to the research community.


Serve as a subject matter expert on current and forthcoming federal and state regulations as they pertain to human subjects research.

Program and Staff Management

Provide leadership for a small team of employees.

Coordinate and supervise training, evaluate and mentor team members, review work products, and provide performance feedback.

Manage and assign new submissions.

Perform additional duties as required.

Senior Compliance Administrator:

Regulatory Review:
Assist in preparing the institution for audits and discussions with regulatory agencies and organizations.

Compliance Operations


Maintain compliance committee membership in accordance with regulations, ensuring a breadth of experience, expertise, and diversity.


In collaboration with Committee Chairs, manage and coordinate reviewer schedules and work with the Committee Chair to ensure consistency across review activities.


Education and Training:
Develop and implement training materials and educational initiatives.


Review new regulations and innovative practices, analyze their impact on compliance workflows and the campus community, and communicate relevant information to Board members, researchers, and other stakeholders.

Program and Staff Management

Provide leadership for a team of employees.

Qualifications:

COMPLIANCE ADMINISTRATOR I:

REQUIRED QUALIFICATIONS:
Bachelor's degree in a relevant field, or equivalent experience

Minimum of 1 year of related experience

PREFERRED QUALIFICATIONS:
Familiarity with research ethics and methodologies.

Experience in human subjects research compliance.

Relevant professional certification (e.g., CIP).

COMPLIANCE ADMINISTRATOR II:

Requirements noted for Compliance Admin I plus:

REQUIRED QUALIFICATIONS:
Minimum of 2 to 4 years, including at least 1 year of experience in human subjects research compliance.

Working knowledge of human subjects regulations (e.g., DHHS, FDA) and guidance applicable to human subject research studies.

PREFERRED QUALIFICATIONS:
Master's degree

Familiarity with software programs developed for research administration or web-based submissions and tracking.

COMPLIANCE ADMINISTRATOR III:

Requirements noted for Compliance Admin I plus:

REQUIRED QUALIFICATIONS:


Minimum of 5-7 years of experience in administration, management, and policy, preferably within an academic institution, hospital, or government IRB including at least 2 years of experience in human subjects research compliance.

Familiarity with AAHRPP standards and requirements.


Relevant professional certification (e.g., CIP); Willingness to obtain certification within a reasonable timeframe (6 to 12 months) as a certified IRB professional (CIP) upon meeting the eligibility requirements and to maintain certification through continuing education and re-certification for the duration of employment.


SENIOR COMPLIANCE ADMINISTRATOR:

Requirements noted for Compliance Admin I plus:

REQUIRED QUALIFICATIONS:


Minimum of 7 years of experience in administration, management, and policy, preferably within an academic institution, hospital, or government IRB including at least 3 years of experience in human subjects research compliance.

Extensive knowledge of human subjects regulations (e.g., DHHS, FDA) and guidance applicable to human subject research studies.

At least 1 year of experience training or mentoring staff.