Manager Human Subject Protection Program

TEEMA; Illinois; On-site; USD 120,000 - 170,000; Full time

Job summary

TEEMA is seeking an experienced Manager, Human Subject Protection Program (HSPP) to lead our clinical research governance in a single FWA environment. The role directs regulatory compliance, education, and collaboration with IRBs and IBCs across a diverse biomedical portfolio.

You will oversee the HSPP functions, mentor RCAs, and drive risk-based oversight while partnering with Research Administration, Legal, and clinical leadership to ensure patient safety and ethical research practices.

Qualifications

• Bachelor's degree required in a relevant field (Biological/Life Sciences or allied field).
• Minimum 5 years in clinical research or research compliance.
• At least 2 years in supervision/management.
• Experience with external IRBs as relying institution.
• Active CIP or CHRC certification (must obtain within 1 year if not active).
• Strong knowledge of 45 CFR 46, 21 CFR 50, 21 CFR 56, HIPAA.

Responsibilities

• Provide operational and regulatory leadership for the Human Subject Protection Program (HSPP).
• Oversee education and training to promote compliance with laws, regulations, and ethical standards.
• Maintain local institutional oversight across the research enterprise.
• Manage external IRB reliance arrangements and regulatory reporting.
• Lead a team of Research Compliance Analysts (RCAs) and mentor staff.
• Develop policies, governance processes, and risk-based oversight models.
• Support audits, investigations, and corrective action plans.

Skills

Regulatory compliance

Leadership

Communication

Stakeholder management

Education

Bachelor's Degree in a relevant field

Master's Degree in Biological/Life Sciences or related field

Tools

Microsoft Office Suite

Epic (research functionality)

Research databases

Job description

We are seeking an experienced, knowledgeable, and collaborative Manager, Human Subject Protection Program (HSPP) to join a growing healthcare research organization and play a pivotal leadership role in advancing ethical, compliant, and high-impact clinical research!

This is an exciting opportunity for a seasoned clinical research professional who thrives at the intersection of regulatory compliance, operational oversight, investigator collaboration, and enterprise risk management.

In this role, you will provide leadership and oversight for the organization's Human Research Protection Program within a single Federalwide Assurance (FWA) environment, supporting a diverse portfolio of biomedical clinical trials, academic research, and investigator-initiated studies.

Because the organization primarily relies on external Institutional Review Boards (IRBs) and Institutional Biosafety Committees (IBCs), you will serve as a key liaison between the healthcare system and these external entities while maintaining strong local oversight, institutional accountability, and regulatory compliance.

You will also lead and mentor a team of Research Compliance Analysts (RCAs), collaborate with research administration and clinical leadership, and help shape policies, governance structures, educational programming, and risk-based oversight strategies.

Duties & Responsibilities

Human Subject Protection & Regulatory Compliance

Provide operational and regulatory leadership for the Human Subject Protection Program.

Oversee administrative and educational programming that promotes and supports compliance with applicable laws, regulations, ethical principles, and professional standards governing human subject research.

Maintain local institutional oversight of research activities throughout the broader research enterprise.

Ensure research activities comply with federal, state, and local regulations, as well as organizational policies for human subject protection.

Lead and support the Human Research Protection Program within a single Federalwide Assurance (FWA) environment.

Oversee external IRB reliance arrangements, local oversight, event reporting, and compliance monitoring.

Coordinate with external Institutional Review Boards (IRBs) and Institutional Biosafety Committees (IBCs).

Serve as a key liaison between the healthcare organization and external research oversight entities.

Support compliance across biomedical clinical trials, academic research, and investigator-initiated research activities.

Research Oversight, Risk Management & Quality Improvement

Help develop and strengthen policies, governance processes, educational programming, and risk-based oversight models.

Support research compliance monitoring, including audits, investigations, and corrective-action planning.

Support enterprise research governance through the Research Oversight Council (ROC).

Develop scalable processes, performance metrics, and continuous improvement strategies.

Help identify opportunities to improve research oversight, compliance practices, and operational efficiency.

Support research activities moving forward efficiently without compromising regulatory compliance or patient safety.

Contribute to enterprise risk management and research compliance initiatives.

Leadership & Staff Development

Lead, manage, and mentor a team of Research Compliance Analysts (RCAs).

Provide professional guidance and regulatory support to research compliance staff.

Support the development of educational programs and training initiatives related to human subject protection.

Foster a collaborative, service-oriented environment that promotes accountability, professional development, and ethical research practices.

Partner closely with Research Administration Leadership, Compliance, Legal, Privacy, and clinical leaders.

Serve as a trusted advisor to investigators and organizational leadership regarding human subject protection requirements.

Communicate complex regulatory requirements clearly to researchers, clinical staff, and other stakeholders.

Collaborate with internal and external partners to address compliance questions, research oversight concerns, and operational challenges.

Balance service to investigators with strong regulatory accountability.

Program Development & Strategic Initiatives

Contribute to the continued development and improvement of research policies, governance structures, and educational programming.

Support the development of sustainable oversight processes for an expanding and increasingly complex research enterprise.

Manage multiple projects and competing priorities while maintaining regulatory and ethical standards.

Promote a proactive, solution-oriented approach to compliance management and continuous improvement.

Required Qualifications

Education

Bachelor's Degree in a relevant field, such as Biological Sciences, Life Sciences, or another related field.

Professional Experience

Minimum of 5 years of direct experience in clinical research or research compliance.

At least 2 years of supervisory or management experience.

Experience managing or leading research-related personnel.

Experience working with external Institutional Review Boards (IRBs) as a relying institution.

Knowledge of the IRB process for both minimal-risk research and complex biomedical clinical trials.

Familiarity with regulations governing human subject protection, including:

45 CFR 46

21 CFR 50

21 CFR 56

HIPAA

Experience conducting research compliance monitoring and audits.

Experience conducting investigations and developing corrective-action plans related to research compliance.

Required Certification

Certified IRB Professional (CIP) certification OR Certified in Healthcare Research Compliance (CHRC).

Candidates who do not currently hold an active CIP or CHRC certification must obtain one within 1 year of hire into the role.

Regulatory & Technical Knowledge

In-depth knowledge of human subject protection regulations and ethical research guidelines.

Strong understanding of research compliance requirements and regulatory oversight.

Solid computer skills, including proficiency with Microsoft software.

Proficiency with research compliance software and databases.

Proficiency with Microsoft Office Suite, including Word, Excel, PowerPoint, and related applications.

Leadership, Communication & Professional Skills

Excellent interpersonal, written, and verbal communication skills.

Strong analytical and problem-solving skills with excellent attention to detail.

Strong organizational and project management skills, with the ability to manage multiple tasks and priorities.

Ability to communicate complex regulatory requirements clearly to researchers and staff.

Strong decision-making and problem-solving abilities, particularly in high-pressure situations.

Ability to work collaboratively with diverse teams, including researchers, clinical staff, legal counsel, and regulatory agencies.

Proactive, solution-oriented approach to managing compliance.

Strong commitment to communication and collaboration with internal and external stakeholders.

Ability to navigate complex organizations, competing priorities, and organizational change.

Ability to balance investigator support with firm regulatory accountability.

Desired Qualifications

Education

Master's Degree in Biological Sciences, Life Sciences, or another closely related field.

Leadership & Research Experience

5 years of experience in a formal leadership role.

10 years of direct experience in research compliance, research administration, and/or human subject protection.

Experience conducting human subjects research.

Experience with post-approval monitoring.

Experience in project management and policy development.

Experience in research ethics.

Experience working in the industry clinical trial environment.

Experience collaborating with academic or university research partners.

Experience developing training and educational program content.

Experience training and mentoring staff and investigators.

Research Systems, Contracts & Compliance

Familiarity with Epic and its research functionality.

Experience with research-related contracts, including:

Material Transfer Agreements (MTAs)

Data Sharing and Use Agreements

Clinical Trial Agreements

Additional Preferred Knowledge & Skills

Basic knowledge and understanding of the regulatory, operational, logistical, and administrative requirements of clinical research studies.

General understanding of medical and clinical terminology.

Demonstrated ability to develop training materials, train individuals, and provide education to small and large groups.

Compensation & Incentives

Location, Setting & Work Type

Job Title: Manager, Human Subject Protection Program (HSPP) – Clinical Research
Department: Clinical Research | Research Compliance
Leadership Responsibility: Research Compliance Analysts (RCAs)
Research Oversight: External IRB/IBC Reliance | Institutional Oversight | Single FWA Environment
Minimum Experience: 5 Years in Clinical Research or Research Compliance
Management Experience: Minimum 2 Years
Required Education: Bachelor's Degree in a Relevant Field
Required Certification: CIP or CHRC (Must Obtain Within 1 Year of Hire if Not Active)