The primary purpose of the Regulatory Compliance Coordinator is to provide departmental administrative support, management interface, operational management for clinical trials, and quality assurance expertise to ensure departmental compliance with regulatory accreditation agencies. This position will direct and plan special administrative assignments and programs; direct the preparation of reports and other documentation required for the department and/or programs. This position will also coordinate policy development, implementation and completion, the design, execution, and effectiveness of quality assurance programs. This position will serve as back up to Supervisor, Clinical Studies in his/her absence.
Regulatory Compliance Coordinator opportunity in Melanoma Medical Oncology. The ideal candidate will have a bachelor’s degree in business administration, or healthcare discipline, and at least eight years of professional experience to include three years of the following: policy development, quality assurance, regulatory compliance, strategic planning or similar directly related experience.
Experience with FDA regulations, CFR, GCP, and IRB guidance, including training and educating personnel, and extensive QA/QI experience and involvement, is highly desirable.
KEY FUNCTIONS:
Project Oversight
• Direct activities that help to resolve operational and budget issues associated with grants and protocols as directed by the respective PIs and responsible personnel.
• Design, establish, and monitor progress of projects through the applicable database systems.
• Coordinate, compile, and maintain project-specific status reports.
• Coordinate the preparation of regulatory documents in accordance with FDA guidelines and assist with quality assurance of all research protocols.
• Assist with the coordination of grant and contract proposals, including writing and preparing portions of applications, and editing, proofreading, and collating proposals.
• Assist with the preparation of annual resubmissions and reports for appropriate agencies on an as-needed basis.
• Serve as backup for the Manager, Clinical Protocol Administration.
Program and Project Coordination
• Direct, coordinate, and assist in achieving goals for the area of responsibility and offer suggestions/recommendations regarding program operations with the goal of creating efficiencies.
• Coordinate, create, and maintain project timelines.
• Coordinate project meetings and produce quality minutes.
• Assist the Director of Clinical Research, Faculty, and Management team to develop, implement, and execute new clinical trial research processes.
Regulatory and Compliance Oversight
• Direct, coordinate, and assist in achieving goals for the area of responsibility and offer suggestions/recommendations regarding program operations with the goal of creating efficiencies.
• Coordinate, create, and maintain project timelines.
• Assist the Director of Clinical Research, Faculty, and Management team in the timely delivery of recurrent tasks with a high degree of accuracy.
Professional Development and Engagement
• Participate in conferences and serve on committees.
• Attend weekly/monthly research meetings as well as site initiation meetings as required.
• Enhance professional growth and development through in-service meetings and educational programs.
EDUCATION: Required: Bachelor's degree in Business Administration or healthcare discipline.
Preferred: Master's degree in Business Administration or healthcare discipline.
EXPERIENCE: Required: Eight years of professional experience to include three years of the following: policy development, quality assurance, regulatory compliance, strategic planning or similar directly related experience. With preferred degree, six years of required experience.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
