Site Regulatory Manager in Oncology Research

Job Description

Site Regulatory Manager in Oncology Research \n

Location: 701 E Hampden Ave, Englewood, CO 80113 Company: \n

Cutaneous Oncology Services LLC

d/b/a The Melanoma and Skin Cancer Institute \n

Job Post Summary \n

Date Posted: TBD, 2026

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

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The Site Regulatory Manager supports the Clinical Research Department by overseeing regulatory compliance activities for oncology clinical trials conducted at The Melanoma and Skin Cancer Institute. This position is responsible for the preparation, submission, and maintenance of study regulatory documentation, ensuring compliance with Institutional Review Board (IRB) requirements, Good Clinical Practice (GCP) guidelines, FDA regulations, sponsor requirements, and applicable federal, state, and local regulations.The Site Regulatory Manager serves as a key liaison between investigators, sponsors, contract research organizations (CROs), regulatory agencies, and institutional review boards. This role is responsible for managing study startup activities, maintaining regulatory files, supporting audits and inspections, tracking submission deadlines, and ensuring research studies remain in compliance throughout the study lifecycle. Working closely with investigators, clinical research coordinators, and research leadership, the Regulatory Research Coordinator plays a critical role in protecting research participants, maintaining data integrity, and supporting the successful execution of cutting-edge melanoma and skin cancer clinical trials. Work Arrangement: HybridThis position is eligible for a hybrid work schedule. The Site Regulatory Manager will work both remotely and onsite at MSCI locations based on study startup activities, regulatory deadlines, sponsor requirements, team meetings, audits, inspections, and operational needs.\n

REQUIREMENTS General \n

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

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

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

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

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

Full-time

Benefits: \n

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

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• Oncology
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Schedule: \n

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• 8-hour shift
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• Day shift
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• Monday to Friday
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• Hybrid work schedule available based on operational needs
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Ability to Commute: \n

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• Englewood, CO 80113 (Required)
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• Lakewood, CO 80215 (Required)
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Ability to Relocate: \n

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