Site Regulatory Manager in Oncology Research

Cutaneous Oncology Services LLC

Date Posted: TBD, 2026

Pay: $80,000.00 - $110,000.00 per year

• Oncology research experience required
• High degree of planning and organizational skills
• Demonstrates knowledge and understanding of FDA regulations, ICH-GCP guidelines, OHRP requirements, and applicable federal, state, and local regulations governing clinical research
• Develops, establishes, and maintains productive relationships with MSCI staff, sponsors, CROs, regulatory agencies, and institutional review boards
• Collaborates closely with Clinical Research Coordinators, investigators, and research leadership to ensure regulatory compliance and ethical conduct of clinical trials
• Maintains regulatory documentation in compliance with sponsor, institutional, and governmental requirements
• Must maintain Collaborative Institutional Training Initiative (CITI) Human Subject training, GCP training, and CTEP credentialing as required
• Assist with audit preparation and inspections
• Ability to work well in a team and manage conflicts and resolve problems effectively
• Excellent interpersonal skills with proven written, presentation, and verbal competencies
• Strong ability to work autonomously
• Strong ability to multi-task and manage competing priorities
• Ability to drive own vehicle for work (to and from clinics)
• Ability to attend tumor board meetings
• Ability to attend research meetings
• Access to reliable internet
• Proficiency in navigating electronic systems
• Must be able to pass a criminal background check
• Demonstrates behaviors that reflect quality, professionalism, teamwork, and excellence
• Demonstrate ability to lead a team of research professionals and provide direction with regulatory compliance
• Maintains patient confidentiality at all times

• Manage site-level regulatory activities for assigned clinical trials from startup through study closeout
• Prepare and submit initial IRB applications, amendments, continuing reviews, reportable events, study closures, and other regulatory submissions
• Maintain regulatory binders and electronic regulatory files, ensuring documentation is complete, current, and audit-ready
• Maintain investigator qualifications including CVs, medical licenses, GCP training, financial disclosures, and delegation of authority logs
• Track protocol versions, approvals, expiration dates, and regulatory reporting deadlines
• Review study protocols, informed consent forms, investigator brochures, and sponsor-provided regulatory documents
• Coordinate study activation activities and ensure all regulatory approvals are obtained before subject enrollment
• Serve as the primary regulatory liaison with sponsors, CROs, central IRBs, and local IRBs
• Assist investigators and research staff in understanding protocol-specific regulatory requirements
• Submit protocol deviations, violations, unanticipated problems, and serious adverse event reports to appropriate regulatory bodies as required
• Prepare essential documents for sponsor audits, monitoring visits, FDA inspections, and internal quality reviews
• Conduct routine quality control reviews of regulatory files and study documentation
• Maintain study tracking systems for regulatory milestones and submission deadlines
• Assist with development and implementation of regulatory standard operating procedures (SOPs)
• Support research staff during protocol implementation and regulatory training activities
• Assist the clinical research team in preparation for external audits and inspections
• Participate in corrective and preventive action (CAPA) activities as needed
• Monitor changing regulatory requirements and communicate updates to research personnel
• Additional tasks and special projects as requested by supervisor or leadership team
• Works with moderate supervision; escalates questions to Principal Investigators, Research Manager, Director of Research, or Compliance Leadership as appropriate

• Bachelor's degree in biological sciences, health sciences, healthcare administration, nursing, public health, or related field
• Regulatory clinical research experience required
• Minimum of (3) three years of clinical research, regulatory affairs, compliance, or healthcare experience
• Experience with IRB submissions and research regulatory documentation required
• Knowledge of FDA regulations, ICH-GCP guidelines, and human subject protection requirements required
• Strong organizational and time management skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Experience in oncology clinical trials preferred

• Competitive salary and benefits package
• Opportunity to work on cutting-edge oncology clinical research
• Opportunity to contribute to a mission-driven healthcare organization
• Supportive and collaborative work environment
• Professional development and continuing education opportunities
• Opportunity to make a meaningful impact on patient care and organizational growth

• Bachelor's Degree from an accredited four (4) year college or university
• Three (3) years of experience working in health research, regulatory affairs, clinical research administration, or healthcare compliance
• Experience with IRB submissions, regulatory document management, and sponsor interactions required
• Five (5) years of oncology clinical trials experience preferred

Full-time

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Clinical Research Training Program Provided
• Retirement plan
• Vision insurance

• Oncology

• 8-hour shift
• Day shift
• Monday to Friday
• Hybrid work schedule available based on operational needs

• Englewood, CO 80113 (Required)
• Lakewood, CO 80215 (Required)

• Englewood, CO 80113: Relocate before starting work (Required)
• Hybrid with occasional in person flexibility based on business needs.