Job Summary:

The Associate Director of Clinical Trials Regulatory plays a pivotal leadership role in overseeing regulatory startup and ongoing activities and ensuring compliance for multi-site clinical trials within the Clinical Trials Research Consortium (CTRC). This position leverages a comprehensive understanding of clinical trial feasibility, startup procedures, research operations and performance metrics, along with strong communication skills to manage multiple stakeholders and deliverables. Key responsibilities include regulatory management, eRegulatory platform implementation, training and compliance oversight, fiscal and contractual negotiations, and development of operational policies. The role also entails budget planning, process improvement, and serving as a liaison among investigators, legal teams, sponsors, and research staff.

Duties & Essential Job Functions:

Regulatory Management

1. Provides leadership and expertise in execution of regulatory startup and ongoing activities for multi-site clinical trials.
2. Provides training and encourages ongoing educational opportunities to principal investigators and research personnel to ensure regulatory compliance.
3. Oversees implementation of eRegulatory platform by coordinating with employees and external partners handling the integration of the platform, testing and results, communicating requirements and ensuring successful launch. Manages the use of the platform for clinical research regulatory needs.
4. Manages eRegulatory binders by ensuring all necessary and required documents are reviewed and approved, as well as present and accessible to necessary parties. Required documents will include but not be limited to, study protocols, consents, study manuals, Institutional Review Board (IRB) approvals and correspondence, site correspondence, Principal Investigator credentials (including CVs, licenses and related records), normal laboratory ranges, device calibration logs, regulatory agency correspondence, training logs, Serious Adverse Event (SAE) reports, and subject screening and enrollment logs
5. Serves as the principal IRB contact for all participating sites for the submission for multi-site clinical trials.
6. Ensures CTRC is following institutional, state and federal rules, policies and regulations regarding clinical research. Responsible for ensuring protocol compliance and providing recommendations for corrective action when necessary.
7. Meets regularly with program leaders, investigators and research staff to provide necessary updates on active and upcoming studies.
8. Ensures unresolved issues are escalated at the appropriate time to the appropriate level of management.
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 in development of policies and procedures related to multi-site clinical trials in collaboration with external stakeholders.

Fiscal/Budget/Contracting

11. Provides leadership, education, and/or completion of coverage analysis and billing matrices for multi-site clinical trials.
12. Oversees the negotiation of multi-site clinical research budgets. Ensures departmental alignment with budget, consent, and contract language.
13. Serves as liaison with work sites, legal professionals, and sponsors regarding NDA/CDA, and CTAs.
14. Provides leadership and expertise related to establishing financial operations pertaining to multi-site clinical trials.
15. Provides financial analysis and input for annual budget preparations.
16. Identifies and communicates opportunities for improved efficiency and/or cost saving within the CTRC.
17. Participates in operational and feasibility assessments.

Professional Development

18. Keeps abreast of emerging technologies/industry trends in clinical research 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 other related duties as assigned or requested.

Required Education & Experience:

• Bachelor's Degree in a related field.
• 4 years of experience in a Healthcare setting to include three years research management and/or regulatory compliance.

Preferred Education & Experience:

• Master’s Degree in a related field.
• 10 years of experience in a Healthcare 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 trial feasibility, startup activities for multi-site trials, and metrics.
• Knowledge of and skills in applicable research software and eRegulatory platforms.
• Skill in project management and organization.
• Skill in Microsoft Windows, Microsoft Office, and navigation techniques.
• 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 role 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.

EEO 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.