Offer summary

Qualifications:

Bachelor's degree required., Six years of experience with research studies or direct patient care, including three years in a lead or supervisory role., Experience in clinical trial budget operations and compliance with Good Clinical Practice and federal regulations is essential., Completion of specific leadership programs may substitute for supervisory experience..

Key responsabilities:

Oversee and coordinate clinical research budget activities and supervise study coordinators.

Lead budget management efforts for clinical trials and ensure compliance with institutional policies.

Communicate with principal investigators, sponsors, and regulatory bodies regarding budget and contract amendments.

Develop training programs for clinical research personnel and conduct performance evaluations for staff.

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, prevention, and education for undergraduate and graduate students, trainees, professionals, employees, and the public.

JOB SPECIFIC COMPETENCIES

Clinical Trial Regulatory Budget Operations

Oversee the supervision, coordination, and facilitation of clinical research budget activities for the assigned area and direct reports.
Supervise the daily operations of protocol-related research activities of study coordinators to ensure compliance with all standards, policies, and quality measures.
Lead all budget management efforts for clinical trials assigned by the team, based on departmental and disease team priorities. Ensure studies are conducted in accordance with Good Clinical Practice, federal regulations, and institutional policies. Collaborate with NCI and the pharmaceutical industry to update or correct protocol documents. Communicate verbally and in writing with the principal investigator, internal reviewers, external agencies, the Institutional Review Board, and Clinical Research Finance as needed or requested.
Develop and maintain a system for processing and tracking new budgets and budget amendments. Assist faculty with initial study planning, acquire lab manuals, create advanced setups, review coverage determinations, and negotiate budgets. Execute proposals and clinical protocols for the submission of Material Transfer Agreements (MTAs) and Clinical Trial Agreements (CTAs) for legal review, and review/negotiate payment terms. Provide pre- and post-award management for assigned budgets, contracts, and clinical research activities.
Communicate with clinical trial sponsors regarding contract and/or budget amendments. Serve as a liaison between the PI, sponsors, collaborating departments, institutional and departmental leaders, Clinical Research Finance (CRF), Legal, and the Office of Sponsored Programs (OSP). Coordinate, create, and finalize relevant documents/budgets and facilitate processes to obtain institutional approval. In collaboration with PIs and research staff, enhance the budget process, including thorough Coverage Analysis/Determination.
Maintain a tracking system for the budget process and update the PI on the status of budget timelines. Assist in the strategic planning and development of clinical budgets for LOI PI-initiated and correlative studies. Route CTAs for approval based on new budgets and amendments.
Maintain open communication with physicians and regulatory areas to stay informed about upcoming protocols.

Administration/Supervision of Clinical Trial Regulatory Budget Team

Oversee the activities of clinical trial budget personnel, providing guidance, corrective actions when necessary, and coverage during staffing shortages.
Participate in the interview and selection process for clinical research personnel in the budget area.
Develop and maintain a training program for incoming clinical research team members.
Establish performance and productivity standards for staff. Ensure optimal utilization of team personnel, provide timely and ongoing performance feedback, and help maintain required standards to achieve stated goals.
Orient new faculty and support personnel on the department's budget process related to clinical trials.
Complete performance evaluations for directly supervised personnel.
Communicate and enforce departmental and institutional policies and procedures for personnel in the clinical research area.

Professional Development

Identify needs and provide training and guidance on policies and procedures related to managing and monitoring patients on clinical trials, as outlined in the department's training manual and presented during training meetings.
Participate in training and development for personnel, with a focus on effective orientation and ongoing education.
Participate in conducting departmental training sessions to ensure protocol compliance and disseminate new information and policies.
Mentor and encourage clinical research staff to grow professionally by participating in professional organizations, serving on committees, attending journal presentations, seminars, or conferences.

Other Duties As Assigned

Education Required - Bachelor's degree.

Experience Required - Six years experience with research studies or direct patient care obtained from nursing, data gathering or related field to include three years in a lead or supervisory capacity. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, three years of required experience to include three years of lead or supervisory experience. Successful completion of the LEADing Self Accelerate and/or LEADing Self Discover programs may substitute for one year of required supervisory or management experience. Completion of both programs can be substituted for a maximum of two years of supervisory or management experience.

Other - Must pass pre-employment skills test as required and administered by Human Resources.

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

Additional Information