Coordinator, Clinical Research Program (Regulatory) - Leukemia

University of Texas MD Anderson Cancer Center

Houston (TX)

Remote

USD 58,000 - 87,000

Full time

3 days ago

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Benefits offered by this job

Medical coverage starting day one

Paid time off & holidays

Tuition assistance

Pension plans

Job summary

The University of Texas MD Anderson Cancer Center is a premier cancer center focused on patient care, research, education, and prevention. The Coordinator, Clinical Research Program (Regulatory) supports complex clinical research operations in leukemia, overseeing protocol administration, regulatory compliance, and program coordination.

The role partners with physicians, study chairs, sponsors, and research staff to ensure trials are developed, activated, managed, and maintained in alignment

Qualifications

Bachelor's degree in a scientific, healthcare, public health or related field is required.
Experience supporting clinical research programs and protocol administration.
Knowledge of IRB and federal regulations governing clinical trials.
Strong organizational and communication skills; detail-oriented and capable of managing multiple priorities.

Responsibilities

Oversee clinical research protocol development, administrative processing and regulatory activities.
Collaborate with physicians, study chairs and protocol sponsors on protocol design and evaluation.
Serve as liaison with research administration for protocol-related activities.
Ensure all clinical research complies with IRB and federal guidelines.
Maintain schedules for submission of new and revised protocols.
Provide oversight of clinical trial projects, planning and quality assurance within the Leukemia department.
Develop and maintain protocol reference file systems for current protocols and correspondence.

Skills

Regulatory oversight

Protocol administration

IRB compliance

Project management

Stakeholder collaboration

Education

Bachelor's degree in scientific/healthcare/public health field

Job description

Coordinator, Clinical Research Program (Regulatory) - Leukemia

The University of Texas MD Anderson Cancer Center is a world-renowned institution dedicated to cancer patient care, research, education, and prevention. Within the Department of Leukemia, the Coordinator, Clinical Research Program supports complex clinical research operations that advance innovative therapies and improve outcomes for patients with leukemia. The Coordinator, Clinical Research Program plays a critical role in protocol administration, regulatory oversight, and research program coordination.

UT MD Anderson provides an environment where clinical research excellence, collaboration, and continuous improvement are central to its mission. The Coordinator, Clinical Research Program works closely with physicians, study chairs, protocol sponsors, and research staff to ensure clinical trials are developed, activated, managed, and maintained in compliance with institutional and regulatory requirements. The Coordinator, Clinical Research Program also contributes to training, quality assurance, reporting, and grant preparation activities that support departmental research goals.

The ideal candidate will have a bachelor's degree in a scientific, healthcare, business, public health, or related field, along with progressively responsible experience supporting clinical research programs, protocol administration, regulatory compliance, and clinical trial operations. Candidates should demonstrate expertise in coordinating complex research activities, managing protocol submissions and maintenance, ensuring compliance with Institutional Review Board (IRB) and federal regulations, developing reporting and tracking systems, supporting grant preparation efforts, and delivering training programs for research personnel. Professional certifications related to clinical research administration or coordination are valued, along with strong organizational, project management, analytical, communication, and stakeholder collaboration skills. The successful candidate will be highly detail-oriented, capable of managing multiple priorities in a fast-paced environment, and committed to supporting the research mission of The University of Texas MD Anderson Cancer Center through effective coordination of clinical research programs within the Department of Leukemia.

Minimum $27.64/hour - Midpoint $34.62/hour - Maximum $41.59/hour

The typical work schedule is Days

Work Location: Remote

Why Us?

This role directly supports UT MD Anderson's mission to eliminate cancer through outstanding research and innovation. The position offers opportunities to work with leading faculty and research teams, contribute to impactful clinical trials, develop expertise in regulatory and protocol operations, and maintain work-life balance through a remote work environment.

Employer-paid medical coverage starting day one for employees working 30+ hours/week, plus optional group dental, vision, life, AD&D, and disability insurance.

Accruals for PTO and Extended Illness Bank, plus paid holidays, wellness, childcare, and other leave options.

Tuition Assistance Program after six months of service and access to extensive wellness, fitness, and employee resource groups.

Defined-benefit pension through the Teachers Retirement System, voluntary retirement plans, and employer-paid life and reduced salary protection programs.

Responsibilities

Administrative & Regulatory Operations

Provide oversight of clinical research protocol development, administrative processing, and regulatory activities.

Collaborate with physicians, study chairs, and protocol sponsors regarding protocol design, planning, implementation, and evaluation.

Serve as liaison with research administration offices for protocol-related activities.

Ensure all clinical research conducted by the department complies with Institutional Review Board (IRB) and federal guidelines.

Maintain schedules for timely submission of new and revised protocols.

Provide clinical trial project oversight, strategic planning, and quality assurance for research conducted within the Department of Leukemia.

Collaborate with departmental personnel to maintain and improve protocol reference file systems for storing, retrieving, and accessing current protocols and correspondence.

Departmental Standards & Training

Evaluate the effectiveness, accuracy, and training needs of the section.

Coordinate, plan, and oversee training programs while ensuring compliance with departmental standards.

Collect and develop criteria and process information for section and departmental approval and protocol submission.

Conduct orientation for faculty, trainees, and research/administrative support personnel.

Standardize training practices for protocol-related activities.

Provide direct and indirect oversight of research and faculty support staff involved in protocol setup, activation, monitoring, and reporting.

Systematically review and report on faculty assistant compliance with protocol-related job responsibilities.

Information Systems & Reporting

Develop and maintain processing and tracking systems for protocol-related documentation.

Establish and participate in information systems supporting research program development.

Support protocol writing, processing, submission, and maintenance activities.

Prepare detailed and summary reports on section and departmental productivity and responsiveness.

Produce monthly, quarterly, and annual reporting related to protocol operations and research support activities.

Grants Preparation

Provide protocol and protocol-related information for grant applications in collaboration with department stakeholders.

Undertake and oversee clinical trial-related grant applications through public and private funding mechanisms.

Collaborate on large departmental grant applications as a preparation and production specialist.

Support the development of documentation and materials required for grant submission activities.

Education

Required: Bachelor's Degree

Preferred: Master's Degree Nursing, Public Health, Healthcare Administration or related scientific field.

Work Experience

Required: Three years research study or direct patient care experience obtained from nursing, data gathering or other related experience or one year required experience with preferred degree. May substitute required education degree with additional years of equivalent experience on a one to one basis.

The University of Texas MD Anderson Cancer Center offers excellent benefits, including medical, dental, paid time off, retirement, tuition benefits, educational opportunities, and individual and team recognition.

This position may be responsible for maintaining the security and integrity of critical infrastructure, as defined in Section 113.001(2) of the Texas Business and Commerce Code and therefore may require routine reviews and screening. The ability to satisfy and maintain all requirements necessary to ensure the continued security and integrity of such infrastructure is a condition of hire and continued employment.

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