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Open Rank ASCENT IRB Coordinator (Senior – Principal)

Remote · Malaysia Full-time

About the position

  • The Advancing the Science of Palliative Care Research across the Lifespan (ASCENT) Consortium is a national research initiative focused on providing resources, expertise, and coordination across institutions to advance innovative, high-quality research for those living with serious illness and those who care for them.
  • The ASCENT IRB Coordinator will play a central role in supporting a multi‑institutional palliative care research consortium within an academic medical center. This position ensures that all consortium studies comply with federal regulations, institutional policies, and ethical standards governing human subject research. The coordinator will manage IRB submissions, facilitate communication across participating sites, and help ASCENT supported investigators navigate the regulatory landscape unique to palliative and end‑of‑life research.
  • This role is ideal for someone who thrives in a mission‑driven environment, values meticulous regulatory work, and is energized by supporting research that directly improves the quality of life for patients and families.
  • Responsibilities
  • Lead IRB and sIRB oversight for all ASCENT Consortium studies, including preparation, submission, tracking, and maintenance of IRB applications, amendments, continuing reviews, reportable events, and reliance agreements.
  • Serve as the primary regulatory liaison between COMIRB and consortium investigators, providing expert consultation and guidance on sIRB processes and regulatory requirements.
  • Coordinate consortium-wide regulatory operations, ensuring consistent workflows, timely progress across multisite studies, and compliance with federal and institutional standards.
  • Manage regulatory reporting systems, including accurate and timely CROMS data entry and ClinicalTrials.gov registration and results reporting, with alignment across reporting platforms.
  • Provide study support and quality assurance, including pre-IRB review of study materials, audit and monitoring support, RPPR regulatory documentation, and development of SOPs, templates, and best practices.
  • Promote ethical, participant-centered research practices, ensuring informed consent and study procedures protect and respect the needs, vulnerabilities, and safety of seriously ill patients and their families.
  • Requirements
  • Bachelor’s degree in a health‑related field, social sciences, public health, or other relevant field.
  • Two (2) years of professional experience in clinical, behavioral, or health services research, including direct experience with IRB coordination.
  • Nice-to-haves
  • Clinical Research certification from a professional research organization such as SOCRA or ACRP.
  • Experience with IRB submissions (e.g. COMIRB), regulatory documentation, and multi‑site study coordination.
  • Experience with single‑IRB models, reliance agreements, and multi‑site regulatory coordination.
  • Experience with ClinicalTrials.gov and CROMS reporting.
  • Experience supporting federally funded research, including RPPR preparation.
  • Benefits
  • Medical: Multiple plan options
  • Dental: Multiple plan options
  • Additional Insurance: Disability, Life, Vision
  • Retirement 401(a) Plan: Employer contributes 10%25 of your gross pay
  • Vacation Days: 22/year (maximum accrual 352 hours)
  • Sick Days: 15/year (unlimited maximum accrual)
  • Holiday Days: 15/year
  • Tuition Benefit: Employees have access to this benefit on all CU campuses
  • ECO Pass: Reduced rate RTD Bus and light rail service

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