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Regulatory Coordinator I
Colorado Cancer Research Program - Denver, CO
posted about 2 months ago
About the position
The Regulatory Coordinator I at Western States Cancer Research NCORP plays a crucial role in supporting clinical research efforts by managing regulatory compliance for oncology protocols funded by the National Cancer Institute and pharmaceutical companies. This position ensures adherence to federal regulations, Good Clinical Practice, and internal SOPs, while facilitating communication with various stakeholders. The role is hybrid, requiring two days in the office each week.
Responsibilities
- Prepare, collect and maintain regulatory documentation including consent forms, protocols, and safety reports.
- Support the preparation of Institutional Review Board (IRB) submissions by compiling relevant documentation and signatures.
- Organize and maintain electronic regulatory binders for easy access and audit-readiness.
- Facilitate the collection of site training documents and coordinate ongoing amendment training documents.
- Coordinate and communicate with external stakeholders for regulatory purposes from pre-site-selection through close out.
- Enter protocol-specific data into the Clinical Trial Management System (CTMS).
- Communicate updates regularly with research teams to ensure alignment of regulatory requirements and project milestones.
- Facilitate and maintain in-house staff and external site staff credentialing.
- Perform other duties as assigned.
Requirements
- One year of experience in clinical research and regulatory affairs.
- Proficiency in Microsoft Office (Excel, Word, Outlook).
- Associate's degree required; Bachelor's degree in a clinical, scientific, or related discipline preferred.
Nice-to-haves
- Experience working with a Clinical Trial Management System.
- Familiarity with industry-sponsored trials.
- Familiarity with e-Regulatory and/or project management software.
Benefits
- Health savings account
- Health insurance
- On-site gym
- Dental insurance
- 401(k)
- Paid time off
- Vision insurance
- 401(k) matching
- Flexible schedule
- Life insurance
