Research Nurse Manager, Perinatal Research Division

Perinatal Research Division Director

Directs operations for the conduct of perinatal research at UTMB Galveston Campus Hospital & Clinics, UTMB Regional Campus Hospitals and Clinical sites, as well as sub-contract sites- Austin. Responsible for establishing standards of research conduct and practice for all research sites. Establishes mechanisms to ensure that research is conducted in accordance with applicable federal and local agencies, laws, and regulations for protection of human subjects in the United States, including the Office for Human Research Protections (OHRP), Food and Drug Administration (FDA), National Institutes of Health (NIH), UTMB Institutional Review Board (IRB) and UTMB Human Research Protection Program.

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. Manages a research division with funded grants and contract awards totaling over $1,000,000 (direct) annually including supervision of approximately 25 research staff. Manages research facilities (research lab, clinic space, research storage) and equipment including maintenance schedules. Coordinates emergency preparedness plans. Directs, coordinates, and evaluates clinical management of research protocols and clinical research care systems.

Job Duties:

• Designs, implements and manages the research agenda for the Perinatal Research Division.
• Manages conduct of research at all regional obstetric hospital and clinic sites- Galveston, Pearland, Pasadena, Dickinson, Angleton, Clear Lake; as well as sub-sites: St. David's Health Austin
• Develops and maintains harmonious professional and productive relationships system-wide; builds contacts important to achieving work goals; demonstrates diplomacy and tact.
• Serves as effective formal and informal leader of teams and groups; obtains commitment and cooperation; delegates effectively; interviews, hires, counsels and evaluates personnel within assigned areas.
• Builds and implements efficient workflows and system processes to meet research aims and effectively produce research outcomes
• Promotes collaboration between clinicians and research scientists, internal and external to the University.
• Maintains relationships and coordinates collaboration among leaders of multidisciplinary teams including nursing, medical, pharmacy, clinical lab, scientific lab, business administration and regulatory.
• Prepares for and oversees federal and local regulatory agency (FDA, NIH, etc.) audits and inspections, composes responses and prepares action plans to address findings.
• Participates in organizational/departmental committees, and institutional committees with direct impact on research at UTMB, including the Clinical Research Committee (a group of research leaders who advise on future research direction for the university).
• Evaluates and supports development of grant opportunities; reviews and composes documents for grant applications and progress reports.
• Completes feasibility assessments and develops study budgets for NIH and industry funded projects.
• Manages research education and development; including training, and mentorship for faculty, staff, fellows, and residents.
• Fosters research development for the MFM Fellowship and OB/GYN Residency Programs; assists in idea generation and trial start-up, participates as research representative for the MFM Fellowship Interview Committee.
• Coordinates and supervises development of research protocols, including study design, development of research questions, regulatory and institutional review board (IRB) requirements, evaluation of resource requirements, and budgeting.
• Directs conduct of research protocols, provides direction and supervision to research team on initiating research study and protocol related activities.
• Conducts and or supervises training and awareness related to research for internal, hospital, and community groups.
• Coordinates the schedules of research nurses and staff to ensure adequate coverage of protocols.
• Manages on-going strategic plans for the area, ensuring maintenance and stabilization of current infrastructure and planning for future growth and changes utilizing performance metrics and process improvement techniques.
• Manage research lab, clinic space and equipment maintenance schedules
• Coordinates emergency preparedness plans
• Manages Human Resources activities or gives direct input for direct reports in regards to: recruiting and selection, hiring and termination, training, professional development, mentoring, counseling, performance evaluations, and salary planning.
• Provides leadership for the programs(s)/projects(s) and promotes teamwork.
• Actively promotes the professional development of self and others.
• Twenty-four hour accountability is required; Serves as 24 hour on call back up for research patient urgent/emergent assessments, adverse events, and investigational product/specimen freezer failure.

Clinical Research Role

Provides advanced practice health care services as well as documentation of services, collaborates with colleagues, medical director, and principal investigator, supervises assigned support staff, participates in quality assurance activities, and demonstrates a commitment to quality health care.

Nurse Practitioner Essential Job Functions:

• Works independently to full scope of practice in compliance with the Texas Nurse Practice Act with acknowledgement of off-site collaborating physician availability for consultation and collaboration
• Serves as Sub-investigator for clinical research trials; assesses adverse events and coordinates the research plan of care with the medical and nursing plan of care.
• Performs individualized history and physical examinations for diverse populations inclusive of social determinants of health
• Orders and interprets diagnostic testing in accordance with relevant health concerns of the patient
• Diagnoses acute, episodic, and chronic diseases
• Develops a comprehensive plan of care that encompasses evidence-based practice guidelines, practice protocols, Medicare, Medicaid, and other state and federal regulations. Prescribes appropriate pharmacological and non-pharmacological treatments
• Provides appropriate education for current health diagnoses as well as anticipatory guidance for health promotion and disease prevention applicable to the individual's health and socioeconomic status
• Monitors plan of care for cost-effectiveness and the achievement of expected improvements, while openly seeking feedback from patients, significant others, colleagues, allied health, appropriate referrals, and collaborating physician to enhance quality outcomes
• Facilitates patient transition within and between health care services to ensure accurate communication among the health care team
• Documents in a timely manner to ensure all services are accurately accounted for and available for review by the interdisciplinary team
• Adheres to internal controls established for department, all requirements for continued licensure, periodic evaluations, and actively seeks input for identifying actions to improve performance and practice outcomes.
• Supports population and individual health through the prevention, health promotion and chronic disease management.
• Performs related duties as required, including, but not limited to, data collection, staff meetings, preceptor student training, and university-wide compliance/safety training

Federal-NIH and Industry Research Coordinator Job Functions:

• Attends and actively participates in NIH steering committee meetings
• 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, adheres to protocols.
• Supervises preparation of all IRB and Regulatory Documents; under direction of PI may draft various communications with Sponsor, and participates in the revision, development and implementation of documents tools.
• Assesses staffing needs based upon current research activity and implements changes in staffing as needed.
• Monitors recruitment and retention goals and modifies recruitment and retention strategies, as necessary.
• Mentors all clinical research personnel regarding enrollment/recruitment.
• Organizes and facilitates assisting PI in obtaining the Informed Consent process from study participant and documents appropriately.
• Screens patients for protocol eligibility and participation in clinical research.
• Completes an initial patient assessment utilizing interview, observation, and examination; directs and assists others in the nursing process.
• Performs expert physical, pathophysiological, psychosocial, cultural, spiritual, learning needs, and/or age-appropriate nursing assessment of participants.
• Monitors participant's labs and notifies the PI of laboratory findings.
• Identifies patient and family educational needs regarding treatment and follow up on specific clinical research; identifies and coordinates areas of health promotion
• Intervenes and recommends patient needs and/or changes as appropriate to the PI and other health professional.
• Maintains regulatory certification and training for conduct of human subject research.