Job Description

MISSION STATEMENT
The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research, and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees, and the public.

The Supervisor will provide direct administrative and regulatory support for clinical research activities.

The ideal candidate will have a Bachelor\xe2\x80\x99s degree in Science, Healthcare , Nursing or related field and six years of extensive research regulatory administrative experience in a biotechnology or academic setting to include three years of experience with research protocols, and clinical trials regulatory submissions. Three years of lead or supervisory experience is required. Selected candidates will demonstrate strong leadership skills, and competency with written communication and organization.

Onsite presence is required.

JOB SPECIFIC COMPETENCIES

Regulatory Protocol Management

• Coordinate IRB submission of new and amended protocols for the department, including the creation or revision of relevant documents.
• Work with study Principal Investigators (PI), and research staff members to assure that revisions/amendments are submitted to ensure that desired outcomes are reached on a timely basis.
• Collect and develop criteria information for protocol submission.
• Submits study documents in ePRTCL/CTMS for Scientific Review Committee (SRC) and Institutional Review Board (IRB) review.
• Responds on behalf of PI, as appropriate to comments from protocol reviewers. Assists PI, as appropriate with the preparation of responses to SRC and/or IRB.
• Ensures that all reviews are addressed to the satisfaction of the reviewers.
• Acts as a liaison with private industry pharmaceutical companies to aid in the completion of ICD language appropriate for clinical trials.
• Develops and implements best practices, Standard Operating Procedures (SOPs), policies, reporting, analysis, workflows, and auditing of clinical research to ensure compliance with institutional and regulatory requirements.
• Develops and manages the department implementation of systems, policies, and procedures affecting the submission, review, approval, contract negotiation, activation, regulation, and tracking and reporting protocols.
• Review new concepts and protocols in development and provide the PI with recommendations regarding patient safety, protocol inconsistencies, and requirements.
• Participate in project teams to provide regulatory leadership and input. Provide recommendations for how to overcome regulatory barriers.
• Communicate and educate members of the regulatory team and other support staff on changes due to new or related regulatory requirements.

Quality Assurance and Auditing

• Oversees or executes audit preparation for regulatory components.
• Assigns audit preparation activities to team members.
• Collaborates with research nurses and PI to gather and prepare regulatory documentation.
• Works collaboratively with internal and/or sponsor auditors.
• Assists in developing and implementing remediation activities in response to audit findings.
• Executes internal random audits of protocols to ensure ongoing quality research oversight.

Strategic Planning

• Collaborates with leadership in establishing departmental goals, strategies, and procedures in support of business objectives.
• Performs regulatory compliance diligence to support clinical trial goals.
• Orients new faculty and support personnel on the department\xe2\x80\x99s clinical trials research infrastructure and procedures.

Maintaining Integrity of Clinical Trials

• Independently prepares protocol submissions that comply with regulatory and institutional requirements.
• Works with study sponsors and/or Clinical Research Organizations (CROs) to facilitate the approval of regulatory documents that conform to both MD Anderson and sponsor requirements.
• Facilitates cohesiveness and improves regulatory compliance consistency and integration of departmental goals.
• Coordinates activities associated with site start-up and overall regulatory management of the studies.
• Develops and maintains processing and tracking systems for protocol-related documents.
• Reviews protocols, amendments, and ancillary documents for discrepancies and/or lack of clarity.
• Works with PI and/or sponsor to resolve queries.
• Prepares and submits various reports to sponsors, investigators, regulatory authorities, Admin Dir, Protocol Research, and any other stakeholders as deemed necessary.

Personnel Management

• Establishes performance and productivity standards for staff.
• Ensures the appropriate and maximum utilization of team personnel, providing timely and ongoing performance feedback to maintain required standards and achieve stated goals.
• Coaches, mentors, and counsels employees. Implements the disciplinary process within institutional guidelines, if needed.
• Ensures staff attendance at mandatory meetings and compliance with federal, state, and accreditation regulations.
• Orients new faculty/support personnel on the department\xe2\x80\x99s clinical trials research infrastructure and procedures.
• Ensures compliance with Good Clinical Practice (GCP) guidelines.
• Attends in-services, departmental meetings, mandatory training, and/or other events to remain abreast of new policies/procedures affecting the conduct of protocols.
• Disseminates pertinent information to other team members.
• Participates in the
• development of departmental policies and procedures related to protocol research. Assists in the development of educational events for team members.
• Maintains ongoing knowledge of the clinical trial processes at MD Anderson.

Other duties as assigned.

MD Anderson Cancer Center