Details
Can be fully remote - Must be comfortable working EST hours
Essential Duties:
- Manages and monitors policies, practices, and procedures of Senior Regulatory Affairs Specialists, Regulatory Affairs Specialists 2 and Regulatory Affairs Specialists 1 responsible for the management of study portfolios and the execution of regulatory activities for all types of clinical research studies across the lifecycle of the protocol from activation to closeout according to Good Clinical Practice guidelines and applicable federal regulations.
- Responsible for recruiting, hiring, training plans, career development, performance evaluations, disciplinary actions, and day-to-day supervision of the regulatory affairs professionals (Senior Regulatory Affairs Specialists, Regulatory Affairs Specialists 2 and Regulatory Affairs Specialists 1).
- Assigns and manages workload and provides estimates for individual project staffing needs.
- Tracks data and metrics to determine appropriate personnel resource allocation based on study parameters.
- Collaborates with CTO Clinical Research Managers, Project Managers and Principal Investigator (PI) on assessment of highly complex trials clinical research protocols including feasibility, resolving potential discrepancies and/or barriers to enrollment prior to study activation and patient enrollment process. Collaborates with CTO Assistant Director for Regulatory Affairs to oversee preparation for regulatory agency and sponsor audits and inspections.
- Ensures infrastructure to support requirements for clinical trials by evaluating the regulatory, technological, and staff resources required to ensure each clinical trial can be supported in accordance with the study protocol, applicable policies, and regulations.
- Includes assigning regulatory affairs staff (Senior Regulatory Affairs Specialists, Regulatory Affairs Specialists 2 and Regulatory Affairs Specialists 1).
- Collaborates with CTO leadership to develop annual measurable goals and objectives for the CTO; measures progress against those goals to report to Assistant Director for Regulatory Affairs.
- Collaborates with CTO Assistant Director for Regulatory Affairs and Quality and Education unit to determine the best approach for utilizing technology solutions to support clinical research regulatory processes.
- Partners with the CTO Quality and Education unit to ensure proper education and training of regulatory affairs professionals (Senior Regulatory Affairs Specialists, Regulatory Affairs Specialists 2 and Regulatory Affairs Specialists 1) as it pertains to regulatory responsibilities.
- In partnership with the CTO Quality and Education unit, develops, implements, and evolves Oncology specific role-based curriculum for new employees.
- Participates in performance improvement activities by contributing ideas, experience, and expertise to promote efficiency and quality outcomes for the institution and the department.
- Continually identifies opportunities for improvement or enhancement in regulatory processes based on experience and information acquired from other programs, professional associations, review publications and conferences.
- Provides a lead role in developing and coordinating departmental policies and procedures to ensure the efficient regulatory operation of clinical trials.
- Stays abreast of federal and state regulations and local policies.
- Maintains a high degree of knowledge on these requirements, assesses impact of changes to regulations and policies, and follows directives that may be required to ensure University compliance with congruency review and reporting requirements.
- Develops, implements, and champions internal practices that ensure compliance with federal requirements.
- Identifies, facilitates, and coordinates with the Quality and Education team quality improvement activities including conducting internal quality reviews, analyzing results, and identifying trends that would indicate educational needs. Other duties as assigned.
Required Education and Experience:
Bachelor s degree in a health-related discipline and a minimum of seven (7) years of clinical research experience or the equivalent combination of education or experience. Five (5) years of regulatory affairs experience required. Three (3) years of supervisory experience required.