Director of Regulatory Affairs

Department:
SOM KC Cancer Center Clinical Trials

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Regulatory Affairs
Position Title:
Director of Regulatory Affairs
Job Family Group:
Professional Staff
Job Description Summary:
Manages and coordinates a major program or set of programs established to address a key area of specialized need within the University and the community. Provides advanced professional/technical leadership, consultation, and expertise within the program's area of focus, as well as day-to-day administrative and functional management of the program's activities and staff. Sets strategic direction, develops and implements work scope and related operational policies and procedures; establishes funding, and provides operational planning, budgeting, and assessment. Programs/projects managed are of key operational impact, both within and external to the University, and are typically revenue-generating and/or grant-funded from a major funding source or series of funding sources.
Job Description:

This position serves as the Director of the Regulatory Affairs Office of the Clinical Trials Office (CTO), providing regulatory expertise regarding all phases of clinical and translational research for both internal investigators, the Masonic Cancer Alliance (MCA) and in collaboration with outside clients. This position is responsible for the continued development of the regulatory office its services and products in accordance with The University of Kansas Cancer Center (KUCC) strategic plan. As required, this position will also participate in project-related work. This position will direct and supervise functional service and collaborative projects ensuring the clients satisfaction, ensuring client relationship management and quality deliverables related to the regulatory program. This position is responsible for ensuring that all work is completed in accordance with SOPs, policies, practices and state and federal guidelines. This position is located at the Clinical Research Center in Fairway, Kansas.

The University of Kansas Cancer Center is the region's only National Cancer Institute-designated cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.
 

The starting salary is between the minimum and midpoint of the salary range listed.

Required Qualifications:

• Education: Bachelor’s degree in a scientific or healthcare related field or an equivalent combination of relevant post-secondary education and work experience that equals at least 7 years.
• Work Experience: 5 or more years clinical research experience. Minimum of 3 years of management level experience. Previous working knowledge and experience with the FDA and Pharmaceutical sponsors.
• Skills: Demonstrated leadership and administrative skills to properly manage project operations. Attention to detail with excellent analytical and problem-solving skills. Ability to work effectively under periodic stressful conditions. Thorough knowledge and understanding of medical, laboratory, and clinical trial concepts and terminology. Ability to manage multiple tasks and set priorities and meet deadlines. Work within a team approach and be motivated to work consistently in a fast-paced, “customer-focused” environment. Excellent organizational, managerial and communication skills. Ability to motivate staff with respect for team members. Computer literate including Microsoft Word, Excel and Access applications. Familiarity with management database systems utilizing tables, queries, etc. Minimal travel to attend national meetings, etc.

Preferred Qualifications:

• Education: Master's Degree in a scientific discipline.
• Work Experience: 10 or more years of research project management experience in an academic setting, pharmaceutical company environment or in a regulatory agency. 5 or more years management level experience.
• Skills: Extensive knowledge of regulations relevant to drugs, devices, or biologicals in the US.

Job Duties Outlined:

• Direct daily administrative activities of the regulatory staff of up to 30 within the Clinical Trials Office, establish priorities, monitor work, assign and track tasks, responsible for direction of the staff in terms of professional development, selection, performance management, appraisals and discipline. Develop and recommend short and long-term program objectives and strategies for implementation. Develop and implement strategies to increase functionality and efficiency within the regulatory unit of the Clinical Trials Office.

• Direct scope of work, objectives, quality of deliverables, and other project management activities of regulatory projects, which may be local or multi-regional in scope.

• Be knowledgeable, stay current, and act accordingly within the framework of regulatory guidelines provided by federal, state, and local regulatory agencies and ethical guidelines pertaining to the clinical research industry. Monitor and report on Federal and local regulatory issues regarding the conduct of human clinical research. Manage processes pertaining to adverse events to ensure timeliness, accuracy and completeness of reporting. Serve as liaison to investigators, clinical research coordinators, research nurses, pharmacists to ensure appropriate communication channels on regulatory matters are maintained and schedules adhered to. Facilitate communication on regulatory matters and serve as liaison between sponsors, national agencies, investigators, clinical research coordinators, KUMC regulatory bodies, department heads, and others involved in translational clinical research. Act as a regulatory resource to clients of the Clinical Trials Office, evaluate problems and provide solutions.

• Proactively track and monitor study specific trial management activities and systems. Direct the maintenance related to accurate study administration information (trial activity) and regulatory tracking systems in the Clinical Trial Management System (CTMS). Direct and lead activities for regulatory coordinators related to their project-oriented tasks, to ensure that the regulatory program milestones are met as well as milestones related to the strategic plan on the KUCC are met. Responsible for ongoing individual and group training and development of staff, mentoring and coaching, and adherence to organizational policies and procedures.

• Promote a positive work environment that is maintained through open and effective communication. Oversee the regulatory compliance functions and continually review and ensure adequate resources are available to meet project deliverables and milestones. Identify project issues and suggests possible solutions; manage problem resolution through expedient and corrective means. Takes leadership role in the coordination of products and resources. Provide leadership through the continuous development and implementation of improvement related to the regulatory program. Establish, direct and monitor regulatory group compliance of SOPs.

• Establish and ensure proper processes for compiling/collecting, distributing, and tracking regulatory documents and that all e-files, CRIS and/or hard-copy files are maintained. Ensure the effectiveness of the Regulatory Affairs Office of the KUCC by establishing and fostering strong relationships and efficient interactions with KU Cancer Center investigators, Clinical Operations, Clinical Program Management, Site Development, , the KUMC community Institutional Review Boards, Institutional Biosafety Committees, vendors, and sponsors.

• Ensure quality of deliverables for projects of assigned investigators/clients. Participate in proposal and budget development, as needed Oversee regulatory/study administration education activities within the KUCC and other relevant university research groups to ensure that educational programs reflect current trends and regulatory guidelines, as well as, sound educational methods.

• Participate in and serve as senior member in Regulatory meetings, making reports and providing training as required.

• Participates on behalf of the Regulatory group in various site feasibility meetings with potential sponsors.

• Meet with the Clinical Trials Office Senior Director on a weekly basis to routinely provide updates. Provide monthly and yearly operational reports, as necessary, describing details of activity regarding studies and regulatory operations. Prepares written reports and memoranda as needed.

• Perform other duties as may be assigned by the Clinical Trials Office Senior Director.

Required Documents:

• Resume/CV AND Cover Letter

Employee Type:
Regular
Time Type:
Full time
Pay Rate Type:
Salary
Pay Grade:
A14
Pay Range:

Minimum

74688

Midpoint

97509

Maximum

119812

Department:
SOM KC Cancer Center Clinical Trials

-----

Regulatory Affairs
Position Title:
Director of Regulatory Affairs
Job Family Group:
Professional Staff
Job Description Summary:
Manages and coordinates a major program or set of programs established to address a key area of specialized need within the University and the community. Provides advanced professional/technical leadership, consultation, and expertise within the program's area of focus, as well as day-to-day administrative and functional management of the program's activities and staff. Sets strategic direction, develops and implements work scope and related operational policies and procedures; establishes funding, and provides operational planning, budgeting, and assessment. Programs/projects managed are of key operational impact, both within and external to the University, and are typically revenue-generating and/or grant-funded from a major funding source or series of funding sources.
Job Description:

This position serves as the Director of the Regulatory Affairs Office of the Clinical Trials Office (CTO), providing regulatory expertise regarding all phases of clinical and translational research for both internal investigators, the Masonic Cancer Alliance (MCA) and in collaboration with outside clients. This position is responsible for the continued development of the regulatory office its services and products in accordance with The University of Kansas Cancer Center (KUCC) strategic plan. As required, this position will also participate in project-related work. This position will direct and supervise functional service and collaborative projects ensuring the clients satisfaction, ensuring client relationship management and quality deliverables related to the regulatory program. This position is responsible for ensuring that all work is completed in accordance with SOPs, policies, practices and state and federal guidelines. This position is located at the Clinical Research Center in Fairway, Kansas.

The University of Kansas Cancer Center is the region's only National Cancer Institute-designated cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.
 

The starting salary is between the minimum and midpoint of the salary range listed.

Required Qualifications:

• Education: Bachelor’s degree in a scientific or healthcare related field or an equivalent combination of relevant post-secondary education and work experience that equals at least 7 years.
• Work Experience: 5 or more years clinical research experience. Minimum of 3 years of management level experience. Previous working knowledge and experience with the FDA and Pharmaceutical sponsors.
• Skills: Demonstrated leadership and administrative skills to properly manage project operations. Attention to detail with excellent analytical and problem-solving skills. Ability to work effectively under periodic stressful conditions. Thorough knowledge and understanding of medical, laboratory, and clinical trial concepts and terminology. Ability to manage multiple tasks and set priorities and meet deadlines. Work within a team approach and be motivated to work consistently in a fast-paced, “customer-focused” environment. Excellent organizational, managerial and communication skills. Ability to motivate staff with respect for team members. Computer literate including Microsoft Word, Excel and Access applications. Familiarity with management database systems utilizing tables, queries, etc. Minimal travel to attend national meetings, etc.

Preferred Qualifications:

• Education: Master's Degree in a scientific discipline.
• Work Experience: 10 or more years of research project management experience in an academic setting, pharmaceutical company environment or in a regulatory agency. 5 or more years management level experience.
• Skills: Extensive knowledge of regulations relevant to drugs, devices, or biologicals in the US.

Job Duties Outlined:

• Direct daily administrative activities of the regulatory staff of up to 30 within the Clinical Trials Office, establish priorities, monitor work, assign and track tasks, responsible for direction of the staff in terms of professional development, selection, performance management, appraisals and discipline. Develop and recommend short and long-term program objectives and strategies for implementation. Develop and implement strategies to increase functionality and efficiency within the regulatory unit of the Clinical Trials Office.

• Direct scope of work, objectives, quality of deliverables, and other project management activities of regulatory projects, which may be local or multi-regional in scope.

• Be knowledgeable, stay current, and act accordingly within the framework of regulatory guidelines provided by federal, state, and local regulatory agencies and ethical guidelines pertaining to the clinical research industry. Monitor and report on Federal and local regulatory issues regarding the conduct of human clinical research. Manage processes pertaining to adverse events to ensure timeliness, accuracy and completeness of reporting. Serve as liaison to investigators, clinical research coordinators, research nurses, pharmacists to ensure appropriate communication channels on regulatory matters are maintained and schedules adhered to. Facilitate communication on regulatory matters and serve as liaison between sponsors, national agencies, investigators, clinical research coordinators, KUMC regulatory bodies, department heads, and others involved in translational clinical research. Act as a regulatory resource to clients of the Clinical Trials Office, evaluate problems and provide solutions.

• Proactively track and monitor study specific trial management activities and systems. Direct the maintenance related to accurate study administration information (trial activity) and regulatory tracking systems in the Clinical Trial Management System (CTMS). Direct and lead activities for regulatory coordinators related to their project-oriented tasks, to ensure that the regulatory program milestones are met as well as milestones related to the strategic plan on the KUCC are met. Responsible for ongoing individual and group training and development of staff, mentoring and coaching, and adherence to organizational policies and procedures.

• Promote a positive work environment that is maintained through open and effective communication. Oversee the regulatory compliance functions and continually review and ensure adequate resources are available to meet project deliverables and milestones. Identify project issues and suggests possible solutions; manage problem resolution through expedient and corrective means. Takes leadership role in the coordination of products and resources. Provide leadership through the continuous development and implementation of improvement related to the regulatory program. Establish, direct and monitor regulatory group compliance of SOPs.

• Establish and ensure proper processes for compiling/collecting, distributing, and tracking regulatory documents and that all e-files, CRIS and/or hard-copy files are maintained. Ensure the effectiveness of the Regulatory Affairs Office of the KUCC by establishing and fostering strong relationships and efficient interactions with KU Cancer Center investigators, Clinical Operations, Clinical Program Management, Site Development, , the KUMC community Institutional Review Boards, Institutional Biosafety Committees, vendors, and sponsors.

• Ensure quality of deliverables for projects of assigned investigators/clients. Participate in proposal and budget development, as needed Oversee regulatory/study administration education activities within the KUCC and other relevant university research groups to ensure that educational programs reflect current trends and regulatory guidelines, as well as, sound educational methods.

• Participate in and serve as senior member in Regulatory meetings, making reports and providing training as required.

• Participates on behalf of the Regulatory group in various site feasibility meetings with potential sponsors.

• Meet with the Clinical Trials Office Senior Director on a weekly basis to routinely provide updates. Provide monthly and yearly operational reports, as necessary, describing details of activity regarding studies and regulatory operations. Prepares written reports and memoranda as needed.

• Perform other duties as may be assigned by the Clinical Trials Office Senior Director.

Required Documents:

• Resume/CV AND Cover Letter

Employee Type:
Regular
Time Type:
Full time
Pay Rate Type:
Salary
Pay Grade:
A14
Pay Range:

Minimum

74688

Midpoint

97509

Maximum

119812