Regulatory Affairs Supervisor

About the position This position oversees their regulatory unit in the Cancer Clinical Trials Office (CCTO) and directly supervises their assigned regulatory unit staff. The Regulatory Research Supervisor ensures regulatory compliance for clinical research studies, provides leadership and mentorship to regulatory personnel, and collaborates with investigators, sponsors, and research teams to support the timely and compliant conduct of clinical trials. The position also contributes to quality assurance, process improvement, and operational initiatives while serving as a regulatory subject matter expert within the CCTO.

Responsibilities

• Assures adherence within their regulatory unit to all research standards as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), National Cancer Institute (NCI) and other pertinent regulatory agencies.
• Arranges orientation and provides training, supervision, and mentorship to their regulatory unit.
• Supervises vacation, out of office coverage, and time management of direct reports.
• Makes recommendations regarding regulatory personnel issues, including hiring decisions, performance evaluations, counseling, and disciplinary actions with guidance from Regulatory Manager.
• Monitors workload acuity with guidance from the Regulatory Manager.
• Assists regulatory specialists with technical issues, problem solving and intervention when appropriate.
• Answers questions from regulatory team including but not limited to processes, guidance documents, sponsor/ monitor questions, approval committee queries, and department logistics.
• Ensures required timelines are met for submission, approval and distribution of protocol amendments, consent revisions and all applicable protocol specific documents for their regulatory unit.
• Assures compliance with OnCore entries ensuring that accuracy is maintained.
• As part of the regulatory leadership team, collaborates with other Regulatory Supervisors and Regulatory Managers to identify team challenges, solutions, and improvement ideas.
• Develops a firm understanding of institution/department policies and guidance documents, recommending updates as applicable.
• Collaborates with Clinical Research Managers to ensure protocol amendments are processed in an efficient and timely manner.
• Works closely with Regulatory Manager and CCTO Project Manager(s) to ensure protocol opening timelines and protocol opening policies are met and followed.
• Actively participates in Regulatory team meetings and department meetings. This includes providing agenda items and discussion points.
• Participates in external audits and internal process improvement strategies to promote consistent best practices.
• Performs routine quality assurance audits on electronic regulatory binders within their regulatory unit as needed.
• May serve as regulatory contact and carry a regulatory workload as needed for team coverage and understanding of regulatory tasks and job functions.
• Serves as back-up to staff absences, vacancies, within assigned regulatory unit or across regulatory team as needed.
• Serves as back-up to Regulatory Manager if needed.

Requirements

• Bachelor’s degree with a preferred emphasis in business, health administration, communications, biological or social science, or any other field of study related to the work assignment.
• Three (3) years of clinical research experience, with at least 2 of those 3 years in regulatory affairs.
• Applicants must be legally authorized to work in the United States without requiring sponsorship.
• Analytical Skills - Ability to interpret and master complex research protocol information.
• Attention to Detail – Excellent attention to detail and ability to interpret and master complex research protocol information
• Complex Problem Solving – Identifies complex problems and reviews related information to develop and evaluate options and implement solutions.
• Communication Skills - Good command of the English language, and ability to communicate effectively, both written and verbal.
• Interpersonal Skills – Ability to establish and maintain effective working relationships with employees at all level; interacts with people in a friendly, open, honest manner; models a commitment to teamwork; demonstrates respect for the opinions of others; and maintains high level of confidentiality.
• Customer Service – Demonstrates a commitment to excellent customer service, providing internal and external customers with information or assistance in resolving problems.
• Adaptability – Adapts quickly to change and is able to manage multiple priorities and deadlines in a calm, organized manner; is open to new ideas and methods; is able to work independently and as part of a team.
• Planning and Organizing – Sets priorities, anticipates obstacles when planning ahead, manages time effectively to accomplish tasks.
• Technical Skills – Adept at utilizing technology to effectively communicate and complete work (e.g. MS Outlook, MS Word, MS Excel); ability to learn new technology.
• Knowledge of and experience with basic human anatomy, physiology, and medical terminology.
• Intermediate to Advanced Microsoft Office skills (Excel, Word, Outlook).

Nice-to-haves

• Two years Oncology research experience
• Experience with IRB, Ethics Committee
• Working knowledge of Advarra OnCore and Advarra eRegulatory platforms
• Experience with Sponsors and Audits
• Advance knowledge of ICH Guidelines, FDA and HIPAA Regulations
• Additional certification (one of the following): CCRC – Certified Clinical Research Coordinator, CCRP – Certified Clinical Research Professional, CCRA – Certified Clinical Research Associate
• Certification required within 1 year of hire (one of the below): CCRC – Certified Clinical Research Coordinator, CCRP – Certified Clinical Research Professional, CCRA – Certified Clinical Research Associate

Benefits

• Medical: Multiple plan options
• Dental: Multiple plan options
• Additional Insurance: Disability, Life, Vision
• Retirement 401(a) Plan: Employer contributes 10% of your gross pay
• Paid Time Off: Accruals over the year
• Vacation Days: 22/year (maximum accrual 352 hours)
• Sick Days: 15/year (unlimited maximum accrual)
• Holiday Days: 10/year
• Tuition Benefit: Employees have access to this benefit on all CU campuses
• ECO Pass: Reduced rate RTD Bus and light rail service

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