Clinical Trials Operations Manager - Sealy Center Vaccine Development Job
UTMB Health - Galveston, TX

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Job Title: Clinical Trials Operations Manager - Sealy Center Vaccine Development
Job ID: 31255
Location: Galveston
Business Unit: SOMED
Full/Part Time: Full-Time (40 hours)
Regular/Temporary: Regular

Min Qualifications

Nurse Practitioner, Physician Assistant, or Master¿s Degree or equivalent plus four years of relevant experience.

Job Description:
To oversee the operational management related to vaccine clinical trials, including quality assurance and administrative management of industry and federally sponsored clinical trials.

Salary Range

This position is a pay grade CS24 in the Classified Salary Plan.

Specific Job Related Duties

Promote a positive and engaging work environment.
Assign duties, manage work-flow, conduct team meetings, and allocate office space.
Complete annual performance evaluations and develop corrective plan for staff as needed. Participate in decisions around merit and staff compensation. Manage promotions and title changes.
Continuously review unit workloads to determine staffing needs. Hire and terminate staff. Create job postings, determine appropriate salary, and manage recruitment of new employees. Oversee orientation of new staff.
Develop study budgets and conduct negotiations with sponsors. Process budgets through UTMB Research Services. Monitor all accounts monthly to assure compliance and accuracy of expenditures.
Determine study specific staff effort monthly. Compile staffing salary coverage against revenue projections monthly. Compile budget for Sealy Center for Vaccine Development (SCVD) annually.
Analyze research protocols to determine feasibility.
Serve as a protocol resource for staff and investigators. Participate in all protocol team conference calls. Attend offsite investigator training meetings as needed.
Answer protocol and regulatory questions and problem solve for investigators and staff.
Complete site selection surveys, coordinate and conduct site selection visits, site initiation visits, monitoring visits, and close-out visits.
Work closely with the Director, Clinical Trials Group.
Act as liaison between unit medical director and staff to promote information flow.
Oversee petty cash and serve as back up for reconciling petty cash.
Serve as Quality Control Quality Management (QCQM) coordinator for Division of Microbiology and Infectious Diseases (DMID) cooperative group studies. This includes assigning and tracking mandatory staff and faculty training, assigning and tracking monthly Quality Assurance, completing monthly, quarterly, and annual technical reports for each active DMID study, & completing quarterly and annual QCQM reports. Meet monthly to review staff effort.
Update and distribute Standards of Operating Procedures as needed.
Perform back up as needed for unit Research Nurses & coordinators. This may include performing all aspects of clinical trial regulatory duties, completion of study visits, and data management.
Promote unit and solicit new clinical trial opportunities via networking, meetings, and community outreach.
Facilitate expansion of program overseeing renovation, staffing, and start up operations. Maintain an active presence at all SCVD trial facilities (island and mainland).
Adhere to internal controls and reporting structure.

MARGINAL OR PERIODIC JOB FUNCTIONS:
Complete projects for the SCVD leadership group as needed.
Perform related duties as required.

Equal Employment Opportunity

The University of Texas Medical Branch at Galveston is an equal opportunity, affirmative action institution which proudly values diversity. Candidates of all backgrounds are encouraged to apply.