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Regulatory Audit Coordinator

2 weeks, 6 days ago
United States
Full-time
Junior
Compliance Manager
Quality Assurance and Testing
Apply Now
COG RESEARCH FOUNDATION,

COG RESEARCH FOUNDATION,

COG RESEARCH FOUNDATION, is a nonprofit organization established to serve as the federal grantee for the Children's Oncology Group, focusing on advancing research and support for pediatric cancer treatment and care.

Health Care Providers & Services
Founded 2024
View All Jobs 3

Description

  • Review IRB submissions, informed consent content, regulatory documents, protocol deviations, and early closure forms for compliance.
  • Record audit findings, prepare draft and final audit reports, and distribute findings according to SOPs and timelines.
  • Conduct second and for-cause regulatory audits as applicable.
  • Clarify discrepancies and respond to questions from institutions, sites, physician auditors, and CRAs.
  • Evaluate site corrections, update regulatory summaries, and request corrective and preventive actions when needed.
  • Oversee protocol deviation intake in Medidata Rave, route submissions for review, resolve queries, and complete LPO fields.
  • Evaluate early closure requests and coordinate site closures, NCI code changes, and subject transfers with relevant stakeholders.
  • Review regulatory documents for fully industry-funded COG trials and coordinate missing documentation and site status changes.
  • Develop and maintain SOPs, templates, guidance documents, and audit materials.
  • Prepare and deliver regulatory education presentations and participate in meetings with regulatory bodies.

Requirements

  • At least 2 years of experience as a Clinical Regulatory Coordinator, Clinical Trial Auditor, Clinical Trial Monitor, or in relevant human clinical trials research.
  • Bachelor’s degree in biology, chemistry, biochemistry, physiology, nursing, or a related field, or four additional years of related experience in lieu of a degree.
  • Direct knowledge of FDA regulations and ICH-GCP Guidelines.
  • Ability to analyze clinical trial protocols, consent forms, and deviation submissions for compliance issues.
  • Oncology clinical trial experience preferred.
  • Strong attention to detail, accuracy, organization, and ability to manage multiple submissions and deadlines.
  • Ability to work independently and collaboratively while maintaining confidentiality of sensitive study and participant information.
  • Excellent written and verbal communication skills.
  • Proficiency with Microsoft Office and applicable software, including Medidata Rave.
  • Ability to travel to COG Group Meetings and other business-related meetings; U.S. residency required.
  • SOCRA membership and demonstrated regulatory-process knowledge preferred.

Benefits

  • Annual salary range of $70,296–$101,911; typical hiring range of $70,296–$86,104.
  • 100% remote work environment with possible business travel.
  • Medical, dental, and vision insurance options.
  • 401(k), accrued PTO, and paid holidays.
  • Employee Assistance Program, Flexible Spending Account, and wellness stipend.
  • Cell phone and internet stipends.
  • Benefits available to employees working 20 or more hours per week.

Interested in this position?

Apply directly on the company website

Apply Now

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