Director, Clinical Research Compliance & Education

Job Summary:

The Director of Clinical Research Compliance is responsible for the strategic oversight and operational leadership of the Research Consortium’s efforts to ensure compliance with all applicable regulations, policies, and ethical standards governing clinical research. This position provides direction for regulatory startup and ongoing activities related to multi-site clinical trials, with a strong focus on data protection, protocol adherence, and risk mitigation. The Director serves as a key liaison with external auditors, regulatory agencies, and internal stakeholders, ensuring alignment with federal, state, and institutional requirements. The Director leads the development and delivery of compliance-related education and training programs to support researchers, faculty, staff, and students. Through collaboration with senior leadership and cross-functional departments, this position drives the continuous improvement of compliance infrastructure, fosters a culture of research integrity, and implements policies and procedures that promote safe, ethical, and efficient conduct of clinical research.

Duties & Essential Job Functions:

Oversight and Compliance
1. Develops and implements the research compliance program for the Clinical Trials Research Consortium (CTRC).
2. Works collaboratively with partner institutions, affiliate institutions, sponsors, and other stakeholders associated with CTRC.
3. Develops policies, procedures, and timelines for the implementation of the compliance program.
4. Ensures compliance with relevant data protection regulations and guidance (e.g., HIPAA, GCP) and industry standards, particularly related to sensitive research data.
5. Ensures adherence to institutional, state, and federal rules, policies, and regulations regarding clinical research, including protocol compliance.
6. Serves as the primary liaison with external auditors, researchers, and regulatory bodies during monitoring visits, audits, or investigations.
7. Leads and manages large, critical complex areas and teams within clinical research regulatory compliance.
8. Manages scope, schedule, and resources to ensure work is delivered in accordance with research needs, clinical project timelines, and establish quality standards while minimizing risk.
9. Identifies and initiates improvements, tools, processes, and forms to enhance the efficiency and the quality of work performed by the CTRC.
10. Provides leadership and expertise related to multi-site clinical trials to CTRC external stakeholders.

Education/Training
11. Develops and delivers compliance education and training for principal investigators, research staff, and students.
12. Provides guidance and ongoing training opportunities for principal investigators and research personnel to maintain regulatory compliance.
13. Creates and maintains an effective research data security education, training, and awareness program.
14. Collaborates with research sites and research staff to align with compliance standards for clinical research.
15. Guides research teams in the development, execution, implementation, and sustainment of corrective action plan assessments (CAPAs).
16. Identifies and communicates opportunities for improved efficiency and/or cost saving within the CTRC.
17. Participates in operational and executive meetings, providing updates, professional opinions, and other information on compliance efforts.

Professional Development
18. Keeps abreast of emerging technologies/industry trends in clinical research compliance best practices and as appropriate applies them into operations and practices as they benefit the CTRC.
19. Participates in various learning opportunities to enhance knowledge in relation to the role and to maintain research certifications. Attend seminars, forums, and conferences related to clinical research and serves as a representative of the CTRC at such events.
20. Performs additional duties as needed or assigned, contributing to the overall success and responsiveness of the Fort Worth Clinical Trials Research Consortium.

Required Education & Experience:

• Bachelor's Degree in Nursing, Public Health, Research Administration, Health Care Administration, or a related field.
• 6 years of experience in a healthcare or public health setting to include three years research management, regulatory compliance and research related education.

Preferred Education & Experience:

• Master's Degree in Nursing, Public Health, Research Administration, Health Care Administration, or a related field.
• 8 years of experience in a healthcare or public health setting to include four years research management and/or regulatory compliance.

Required Licensure/Certification/Specialized Training:

• None

Preferred Licensure, Certification, and/or Specialized Training:

• Certified Clinical Research Professional (CCRP), or
• Certified Clinical Research Associate (CCRA)

Knowledge, Skills & Abilities:

• Knowledge of clinical research processes: start-up, activation, operationalization, close-out.
• Knowledge of and skills in applicable research software, research platforms, and electronic health records.
• Knowledge and application of federal laws and guidelines related to clinical research (drug and device trials)
• Strong leadership skills and ability to coordinate and lead stakeholders to high performance.
• Exceptional communications skills.
• Ability to focus on multiple deliverables simultaneously.
• Ability to build and maintain relationships with investigators and other external partners and promote growth of Clinical Trials Research Consortium (CTRC).
• Ability to ensure quality and compliance in all trials managed by CTRC.
• Ability to synthesize multiple sources of information.
• Ability to effectively communicate verbally and in writing.

TCU Core Competencies:

University Core Competencies definitions may be found on the Human Resources website and in the staff performance management system.

Physical Requirements (With or Without Accommodations):

• Visual acuity to read information from computer screens, forms and other printed materials and information.
• Able to speak (enunciate) clearly in conversation and general communication.
• Hearing ability for verbal communication/conversation/responses via telephone, virtual communication systems, and face-to-face interactions.
• Manual dexterity for typing, writing, standing and reaching, flexibility, body movement for bending, crouching, walking, kneeling and prolonged sitting.
• Lifting and moving objects and equipment up to 10 lbs.

Work Environment:

• Work is indoors and sedentary and is subject to schedule changes and/or variable work hours.
• This is an on campus, in-person position.
• Occasional travel may be required.
• There are no harmful environmental conditions present for this job.
• The noise level in this work environment is usually low to moderate.

Employment Values Statement:

Texas Christian University values Integrity, Engagement, Community, and Excellence in the workplace. TCU treats applicants and employees with fairness and respect. TCU hires and promotes individuals based on their qualifications and their commitment to making a positive impact on our student-centered community. TCU is an equal opportunity employer and follows all applicable employment laws. TCU fairly considers all qualified individuals, ensuring we are a workplace free from unlawful discrimination and harassment.