Assistant Director of Departmental Research, VPE Education

University of Texas Medical Branch (UTMB)•Galveston, TX

14h•Onsite

About The Position

The Assistant Director of Departmental Research is responsible for the operational oversight of clinical, translational, and basic science research within the Department. Current sites include all UTMB locations including Galveston, Clear Lake, League City and Angleton. The Assistant Director provides overall strategic and operational leadership to support the clinical, translational, and basic science research endeavors of the Department.

Requirements

Master’s or doctoral degree in a related field
7 years of related experience
4 years of progressive management and research experience
Excellent communication, interpersonal, and problem-solving skills with a high degree of professionalism and competence in dealing with faculty and employees at all levels.
Proven ability to foster collaborative and constructive relationships.
Proficiency in balancing complex federal, state, and local regulations, and industry sponsor requirements with Institutional policies and procedures to support and facilitate a world-class clinical research environment.
Knowledge of and ability to function in a collaborative/participatory management environment in order to identify and resolve problems and develop plans, objectives, strategies, tactics, forecasts, and budgets.
Ability to leverage personal skills to achieve high-level results, specifically personal skills in management planning, understanding of academic medical research environment, requirements, and challenges, and ability to overcome barriers to timely and productive results.
Ability to prepare and analyze operating budgets, analyze/evaluate operational data, and utilize this information to make appropriate decisions and recommendations.
Exceptional organizational skills with a focus on results that ensure timely progress on priorities. Ability to get things done and a track record of having done so.
Embraces a compliance culture focused on education, facilitation, and customer service.
Exceptional professional and personal ethics.
Breadth and in-depth knowledge of clinical research quality systems, programs, and trends in an academic environment.

Nice To Haves

Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or similar.

Responsibilities

Establish standards of research conduct and practice for all research sites within their department.
Establish mechanisms to ensure research is conducted in accordance with Institutional policies and procedures and applicable federal and local agencies, laws, and regulations for the protection of human subjects including the Office for Human Research Protections (OHRP), Food and Drug Administration (FDA), National Institutes of Health (NIH), UTMB Institutional Review Board (IRB), and the UTMB Human Research Protection Program.
Integrate a system of operating and monitoring controls related to clinical research including proposal development, review, and post-award billing controls.
Take a leadership role in ensuring clinical research programs and related support areas have high quality and integrity in compliance with Federal, State, and University guidelines.
Stay abreast of new guidelines and best practices in the management of conflict of interests and in the protection of human subjects as they relate to the operational aspects of clinical research in the Department.
Accountable for strategic planning, budgeting, quality assurance, and administration of activities and personnel that affect research protocols and patients, and the development of the assigned staff.
Manage research facilities (clinical research lab, clinic space, research storage) and equipment including maintenance schedules.
Coordinate emergency preparedness plans.
Work with physician leaders and Principal Investigators to ensure all human subjects research activities are appropriate; and, to evaluate regulatory and compliance requirements of research protocols and clinical research care systems.
Manage the clinical and translational research activities at all UTMB campuses and clinic sites for the department.
Develop and maintain harmonious professional and productive relationships Institution-wide; build contacts important to achieving work goals; demonstrate diplomacy and tact.
Serve as the effective formal and informal leader of teams and groups; obtain commitment and cooperation; delegate effectively; interview, hire, counsel, and evaluate personnel within assigned areas.
Build and implement efficient workflows and system processes to meet research aims and effectively produce research outcomes.
Actively promote collaboration between clinicians, research scientists, and other stakeholders internal and external to the University.
Maintain relationships and coordinate collaboration among leaders of multidisciplinary teams including nursing, medical, pharmacy, clinical lab, scientific lab, business administration, and regulatory affairs.
Prepare for and oversee federal and local regulatory agency (FDA, NIH, etc.) audits and inspections, compose responses, and prepare action plans to address findings.
Participate in Departmental and Institutional committees with direct impact on research at UTMB, including the Departmental Research Committee which reviews funding opportunities and proposals, and advises on the research direction and priorities of the Department.
Evaluate and support the development of grant opportunities; review and compose documents for grant applications and progress reports.
Complete feasibility assessments and develop study budgets for NIH and industry-funded projects.
Manage research education and development, including training, and mentorship for faculty, staff, fellows, and residents.
Foster research development for the Department’s Fellowships and Residency Program; may assist in idea generation and trial start-up.
Coordinate and supervise the development of research protocols, including study design, development of research questions, regulatory and Institutional Review Board (IRB) requirements, evaluation of resource requirements, and budgeting.
May direct the conduct of research protocols and provide direction and supervision to the research team on initiating research study and protocol-related activities.
Coordinates the schedules of research nurses and staff to ensure adequate coverage of protocols.
Assists with ongoing strategic initiatives, including the Institutional Research Strategic Plan; ensures maintenance and stabilization of current infrastructure and planning for future growth and changes utilizing performance metrics and process improvement techniques.
Manage Human Resources activities or give input for direct reports related to recruiting and selection, hiring and termination, training, professional development, mentoring, counseling, performance evaluations, and salary planning.
Serves on NIH study sub-committees; actively participates in protocol and operations development, ensuring study procedures are feasible for participants, takes part in central outcome review, and manuscript review.
Attends and participates in the Investigator planning meetings, pre-site, and site initiation visits.
Reports adverse events appropriately and timely.
Reviews goals and requirements of any new protocol, plans and designs source documentation for protocol, and adheres to protocols.
Supervises preparation of all IRB and Regulatory Documents; under the direction of PI may draft various communications with Sponsor, and participates in the revision, development, and implementation of documents tools.
Maintains regulatory certification and training for conduct of human subject research.
Adheres to internal controls and reporting structure.
Performs related duties as required.