Research Regulatory Manager

Tennessee Oncology, one of the nation's largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology's mission remains unchanged: To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home. Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege.
Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.
Job Description:
The Research Regulatory Manager is responsible for the efficient management of clinical Research Regulatory aspects of the Research Department. Provides in-depth knowledge, expertise, ongoing support, education, and training to regulatory and clinical research staff, as assigned, regarding the regulatory conduct of clinical research studies. Serves as regulatory lead for interdepartmental and external agencies, ensuring regulatory compliance for multiple clinical trials. Guides regulatory staff, setting and communicating priorities and performance standards. Stays up-to-date with new and revised standard operating procedures and regulations. Works with departmental leadership to align training and staff development, implementing new training programs to meet emerging/unmet needs.
Specific Responsibilities

• Efficiently manages all regulatory aspects of the Research Department.
• Provides expertise and leadership in the development, preparation and implementation of regulatory strategies to support clinical research missions.
• Coordinates all work of direct reports to shepherd protocols through site qualification, site initiation, IRB submission, and trial activation in a timely manner.
• Manages direct reports in the creation and maintenance of all regulatory documentation
• Oversees regulatory framework, determines pathways and options, and interacts with sponsors, agencies and other academic institutions.
• Approves protocol and document submissions to internal and external regulatory bodies (e.g. Institutional Review Board)
• Ensures and guarantees regulatory compliance for multiple clinical trials through the management of direct reports.
• Serves as regulatory lead for interdepartmental and external agencies, interfacing with sponsors and agencies to ensure compliance with all applicable local, state, federal and international regulations, statutes, and laws.
• Creates and provides solutions to problems, negotiating compromises, and proposing alternatives and recommendations to facilitate and expedite research. Escalates issues as needed, and as requested and/or required by sponsors, participates in and facilitates monitoring visits.
• Oversees data management activities and process maintenance of electronic regulatory files and binders with information pertinent to studying milestone progress (e.g. CTMS, IRB databases, internal/external spreadsheets).
• Prioritizes and manages workloads for direct reports.
• Leads high-quality ongoing compliance reviews of active trials
• Collaborates with other research managers in departmental education efforts, helping to ensure highest quality research and protection of human subjects.
• Laisses with other departments to provide training and staff development, implementing new programs to meet emerging/unmet needs.
• Performs other duties as assigned

• Bachelor's degree or equivalent experience required.
• Knowledge of applicable clinical Research Regulatory requirements i.e., Good Clinical Practice, FDA, HIPAA, and IRB guidelines.
• Ability to interface effectively with all levels of management and must work and communicate effectively with both internal and external customers.
• Excellent organizational and communication skills.
• Ability to effectively function independently and as a team member.
• Microsoft Office proficiency (Word, Excel, PowerPoint, etc.).
• Effective oral, written, communication, interpersonal skills.