RemoteLeaf Logo
Log in Sign up

Regulatory Audit Coordinator

57 minutes 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 4

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

Similar Roles

Oath Biome

Global Regulatory Affairs Lead

Oath Biome Food Products

Oath is seeking a Global Regulatory Affairs Lead to develop and execute regulatory strategies for its global microbial soil-product portfolio, securing market access and maintaining compliance across multiple jurisdictions.

United States Full-time Lead Compliance Manager
57 minutes ago
JustMarkets

Licensing Project Specialist

JustMarkets 1-10 Capital Markets

JustMarkets is seeking a Licensing Specialist to manage legal and regulatory licensing operations across multiple jurisdictions supporting its global fintech, crypto, FX, and payments business.

Europe Full-time Mid Level Compliance Manager Project Manager
3 days ago
FamilyWell

Security & Compliance Manager

FamilyWell 11-50 Health Care Providers & Services

FamilyWell Health is hiring a Security & Compliance Manager to run the day-to-day security and compliance operations for its HIPAA-regulated, AI-enabled virtual mental healthcare platform as the company expands nationally.

Anywhere Full-time Mid Level Compliance Manager
$132k-$140k
Encryption Penetration Testing
4 days ago
Binance

Sanctions Advisory Specialist

Binance 5K-10K Capital Markets

Binance is hiring a mid-level Financial Crime Compliance professional for its global Sanctions Advisory team to provide expert guidance, assess sanctions risks, and strengthen compliance controls across the blockchain ecosystem.

Middle East Asia Africa Full-time Mid Level Compliance Manager
Agile Blockchain
4 days, 1 hour ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers