Assistant Director Clinical Research (Research Administration - Galveston)

EDUCATION & EXPERIENCE

Minimum Qualifications:

• A bachelor's degree in nursing with a minimum of five years of related experience in clinical research operations with increasing responsibilities. A minimum of two years in a supervisory capacity.
• Specific knowledge of clinical trial management systems, clinical trial contracting, and research billing compliance.
• Familiarity with federal regulatory requirements for the conduct of clinical research.
• Experience in an academic medical setting or university environment.

Preferred Qualifications: (For Associate Director and above jobs.)

• Experience and understanding of clinical research and trials regulatory environment in an academic setting and a history of performance effectiveness in this environment are highly desirable.
• Demonstrated record of leadership ability and accomplishment is desirable.
• Prior experience utilizing OnCore, a clinical trial management system, is highly desirable.
• Advanced degree. Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC)

LICENSES, REGISTRATIONS OR CERTIFICATIONS

Required:

• Registered Nurse.

JOB SUMMARY

The Assistant Director of Clinical Research, reporting to the Director of Clinical Research, assists with overseeing the day-to-day operations of the Office of Clinical Research. This position supports the Director in developing and implementing a business strategy to adhere to the budget and financing provisions for the continued growth of clinical research operations.

JOB DUTIES:

• Assists in developing, implementing, and overseeing institutional processes, systems, educational programs, and other activities necessary to support and grow clinical research activities at UTMB. 
•  Provides support and feedback for strategic leadership, including planning, goal setting, and monitoring organizational performance to ensure cost-effectiveness and high-quality programs. Assist UTMB institutional efforts to support clinical research, investigators, and teams. Assist in operational and regulatory review and negotiation of industry-funded clinical research agreements.
• Provide project management expertise in implementing and maintaining a cloud-based electronic regulatory binder system. Provide leadership in using technology and best practices to ensure continuous process improvement. Provide support and education targeted to clinical research coordinators, nurses, and other front-line team members. 
•  Takes a leadership role in ensuring UTMB clinical research programs are of high quality and have integrity in compliance with federal, state, and university guidelines. Review and develop institutional policies and standard operating procedures for quality clinical research activities. 
•  Review and identify issues in the clinical research billing enterprise, including the accuracy of the study calendar and coverage analysis for each clinical research study, budget negotiation, and charge review related to clinical research activities to ensure billing compliance. 
•  Works closely with the Research Nurse Manager of the Research Coordinator Support Services (RCSS), an internal resource for the conduct of clinical research comprised of trained research coordinators and nurses who provide clinical research support services to researchers at UTMB, spanning the study life cycle from study start-up to study closure.
• Communicates changing areas of clinical research risk to the Director and recommends policies, as needed, to address and mitigate those risks; reviews and establishes working relationships within the research, finance, and compliance communities. Monitors regulatory developments in the clinical research area to support the Director's in-house expertise on compliance matters for clinical research administration staff. 
•  Exercises authority as delegated by the Director to communicate appropriate matters to the Provost, Associate Vice President for Research Administration, Compliance Office, Office of Research Integrity and Regulatory Affairs, and senior management as needed, and fosters open communication across the institution.
• Responsible for professional development of subordinate staff; promotes education and cross-training to maximize staffing potential. Supports further development of comprehensive training programs, with measures for continued review of relevant content, and assists in training sessions as needed. 
•  Works closely with the Oncology Clinical Trial Office (OCTO) Research Nurse Supervisor. Provides guidance to coordinate oncology clinical trials in various UTMB locations.
• Supports developing and implementing a peer-review program to evaluate various teams' audit readiness and assess policies' effectiveness; manages internal and external participants in these reviews; and reports findings to the Director.
• Keeps abreast of new guidelines, national discussions, and best practices in managing conflict of interest and protecting human subjects related to clinical research's operational aspects. Upon instruction from the Director, communicate appropriate matters to the Vice Provost, the Associate Vice President for Research Administration, the Medical Director, the school leadership, the IRB/COI leadership, or other necessary leaders to enhance the integration of review activities with operations.
• Identifies appropriate internal controls for RCSS and the OCTO; provides mechanisms to evaluate their effectiveness and efficiency.
• Responsible for coaching and supervising staff by analyzing workload, determining work priority, assigning duties, and overseeing work progress and staff development.
• Responsible for the management of staff. Directs and manages assigned staff, including hiring, performance management, scheduling of work assignments, disciplinary actions, promotions, and transfers.
• Performs annual staff performance evaluations and develops performance management programs. 
•  Coordinates regular staff meetings to communicate departmental and organizational activities, goals, and policies.
• Provide recommendations to the Director regarding organizational structure, resource needs, and standardization of departmental operations. 
• Establishes credibility, trust, rapport, and a good working relationship with staff, management, and faculty. Promotes a team philosophy and a spirit of open communication and responsiveness. 
•  Supports and interprets the institution's purpose, philosophy, objectives, and operations to ensure the best service is available to the research/academic community. Adheres to internal controls and reporting structure. Performs related duties as required

Marginal or Periodic Functions:
• Adheres to internal controls and reporting structure.

• Performs related duties as required.

KNOWLEDGE/SKILLS/ABILITIES

• Excellent communication, interpersonal, and critical thinking skills with high professionalism and competence in dealing with faculty and employees at all levels.
• Ability to foster collaborative and constructive relationships.
• Proficiency in balancing complex federal, state, and local regulations with institutional policies and procedures to support and facilitate a world-class clinical research environment.
• Ability to leverage personal skills to achieve high-level results, specifically personal skills in management and planning, understanding of academic medical research environment, requirements, and challenges, and overcoming barriers to timely and productive results.
• Knowledge of clinical research quality systems, programs, and trends in an academic environment.

SUPERVISION
Received: Director of Clinical Research
Given: Research Nurse Manager and Research Nurse Supervisor. Additional positions based on
department growth.

BUDGET RESPONSIBILITY
Direct: $2M
Indirect: $10M

DECISION-MAKING RESPONSIBILITY
The Assistant Director will be responsible for day-to-day tactical/operational decisions involving the
Research Coordinator Support Service and Oncology Clinical Trial Office with consideration for Federal,
State, and Institutional regulations and policies.

WORKING ENVIRONMENT/EQUIPMENT
The incumbent uses a standard office environment at UTMB's main campus or other locations.
The position requires incidental travel (as the budget allows and can be planned) to Austin and regional
and national meetings to keep abreast of current issues and trends. Physical demands are typical of office
positions. The position requires attending multiple meetings across the breadth of the UTMB campus (this
position is best managed by 'walking around' and being visible to the research community).
May be exposed to occupational hazards such as communicable diseases, blood-borne pathogens,
ionizing and non-ionizing radiation, hazardous medications, and disoriented or combative patients or
others.
Description of equipment this job will/could utilize: Computer, printer, scanner.

DECISION-MAKING RESPONSIBILITY

The Assistant Director will be responsible for day-to-day tactical/operational decisions involving the Research Coordinator Support Service and Oncology Clinical Trial Office with consideration for Federal, State, and Institutional regulations and policies.

WORKING ENVIRONMENT/EQUIPMENT

The incumbent uses a standard office environment at UTMB's main campus or other locations. The position requires incidental travel (as the budget allows and can be planned) to Austin and regional and national meetings to keep abreast of current issues and trends. Physical demands are typical of office positions. The position requires attending multiple meetings across the breadth of the UTMB campus (this position is best managed by 'walking around' and being visible to the research community). May be exposed to occupational hazards such as communicable diseases, blood-borne pathogens, ionizing and non-ionizing radiation, hazardous medications, and disoriented or combative patients or others. Description of equipment this job will/could utilize: Computer, printer, scanner

Any qualifications to be considered as equivalents in lieu of stated minimums require the prior approval of the Vice President for Human
Resources and Employee Services. The University of Texas Medical Branch at Galveston is an Equal Opportunity/Affirmative Action University.
Specific job requirements or physical location of some positions allocated to this classification, may render this position security sensitive, and
thereby subject to the provisions of Section 51.215, Texas Education Code.

Salary Range:  Actual salary commensurate with experience or range if discussed and approved by hiring authority.