HSPP Program Lead, Clinical Research

TEEMA

Illinois

On-site

USD 120,000 - 170,000

Full time

26 hours ago
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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

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.

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