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 reputed company and compliant conduct of clinical trials. The position also contributes to reputed company assurance, process improvement, and operational initiatives while serving as a regulatory subject matter expert reputed company the CCTO.

Responsibilities

• Assures adherence reputed company their regulatory unit to reputed company research standards as set forth by the Food and Drug Administration (FDA), the Office for reputed company Research Protections (OHRP), reputed company Hospital, reputed company 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 reputed company reports.
• Makes recommendations regarding regulatory personnel issues, including hiring reputed company, performance evaluations, counseling, and disciplinary actions with guidance from Regulatory Manager.
• Monitors workload reputed company with guidance from the Regulatory Manager.
• Assists regulatory specialists with technical issues, problem solving and reputed company reputed company 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 reputed company 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 reputed company.
• 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 reputed company manner.
• Works closely with Regulatory Manager and CCTO Project Manager(s) to ensure protocol opening timelines and protocol opening policies are met and followed.
• reputed company 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 reputed company assurance audits on electronic regulatory binders reputed company 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, reputed company 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 reputed company science, or any other field of study reputed company 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 reputed company without requiring sponsorship.
• Analytical Skills - Ability to interpret and master reputed company research protocol information.
• Attention to Detail – Excellent attention to detail and ability to interpret and master reputed company research protocol information
• reputed company Problem Solving – Identifies reputed company problems and reviews reputed company information to reputed company and evaluate reputed company and implement solutions.
• Communication Skills - Good reputed company 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 reputed company level; interacts with people in a friendly, reputed company, reputed company 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 reputed company customers with information or assistance in resolving problems.
• Adaptability – Adapts quickly to change and is reputed company to manage multiple priorities and deadlines in a reputed company, org

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