Clinical Trial Program Manager (Cizik School of Nursing)

UTHealth Houston; Houston (TX); Vor Ort; USD 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

100% paid medical premiums for full‑t/

Generous time off including holidays,

Longevity Pay after 2 years

Retirement/pension plan

Free counseling services

Gym membership discounts & wellness

Employee discounts

Child and elder care resources

Zusammenfassung

UTHealth Houston is seeking a Clinical Trial Program Manager to coordinate and manage clinical trial operations, including subject recruitment, site development, enrollment, and monitoring. The role includes overseeing Roybal Center trials, DSMB protocols, and NIH/DSMB communications, with oversight of reporting and regulatory compliance.

The position also provides programmatic support for Center activities, such as consultations, website/repository development, and organizing annual meetings.

Qualifikationen

• Bachelor's degree required. RN licensure may be required depending on trial.
• 5 years of relevant experience in pharmaceutical or clinical research preferred.
• HSR training (CITI) may be required depending on trial.
• Bilingual English/Spanish preferred.

Aufgaben

• Coordinate and manage subject recruitment, site development, and enrollment.
• Oversee clinical trial monitoring and regulatory reporting.
• Maintain communications with sites, investigators, and CROs; prepare budgets and training as needed.
• Provide programmatic support for Center activities, including meetings and website/repository development.

Kenntnisse

Bilingual - English/Spanish

Ausbildung

Bachelor's Degree

RN Licensure (TX BON) if required

Jobbeschreibung

We are looking for a Clinical Trial Program Manager to coordinate and manage clinical trial operations, including subject recruitment, site development, enrollment, clinical trial monitoring, and regulatory reporting. The Program Manager will oversee Roybal Center clinical trials, including DSMB protocols and reporting, monthly CROMS and enrollment reports, ClinicalTrials.gov reporting, and communication with NIH and DSMB regarding trial status. This position will also serve as a clinical trial support and knowledge resource for ongoing Center trials and provide administrative and programmatic support for Center activities, including project consultations, website and repository development, and organization of the annual meeting.

What we do here changes the world. UTHealth Houston is Texas’ resource for healthcare education, innovation, scientific discovery, and excellence in patient care. That’s where you come in.

Once you join us you won't want to leave. It’s because we reward our team for the excellent service they provide. Our total rewards package includes the benefits you’d expect from a top healthcare organization (benefits, insurance, etc.), plus:

• 100% paid medical premiums for our full-time employees
• Generous time off (holidays, preventative leave day, both vacation and sick time – all of which equates to around 37-38 days per year)
• The longer you stay, the more vacation you’ll accrue!
• Longevity Pay (Monthly payments after two years of service)
• Build your future with our awesome retirement/pension plan!

We take care of our employees!

• Free financial and legal counseling
• Free mental health counseling services
• Gym membership discounts and access to wellness programs
• Other employee discounts including entertainment, car rentals, cell phones, etc.
• Resources for child and elder care
• Plus many more!

Position Summary:

Coordinates and manages subject recruitment, site development, enrollment of human subjects and clinical trial monitoring.

Position Key Accountabilities:

• Oversees all aspects of the clinical trial.
• Identifies and evaluates programs, companies, universities/colleges, etc., where large populations of potential subjects reside.
• Identifies, develops, and maintains suitable site(s) for on-going trial visits.
• Develops and implements presentations/recruiting initiatives for clinical trials including presenting to potential trial subjects.
• Maintains regular communication with clinical sites, investigators, subcontractors, and/or pharmaceutical companies.
• Interacts with project teams and provide required/necessary training.
• May create annual budget, negotiate with service contracts, and reports on progress and authorizes expenditures.
• Manages Human Resources activities of department in regards to: recruiting and selection, hiring and termination, training, professional development, mentoring, counseling, performance evaluations, and salary planning.
• Performs other duties as assigned.

Certification/Skills:

• Bilingual - English/Spanish preferred
• Work may involve handling biohazardous, chemical, and radiological materials, as well as operating associated equipment. Required safety training and appropriate engineering and administrative controls including the use of personal protective equipment must be followed.
• Registered Nurse (RN) State Licensure or Nurse Licensure Compact (NLC) by Texas Board of Nursing (BON) depending on clinical trial, may be required
• Human Subjects Research (HSR) by Collaborative Institutional Training Initiative (CITI Program) depending on clinical trial, may be required

Minimum Education:

Bachelor's Degree required In the event that an RN degree is required, the bachelor's degree may be waived

Minimum Experience:

5 years of relevant experience required Pharmaceutical or clinical research strongly preferred

Physical Requirements:

Exerts up to 100 pounds of force occasionally and/or up to 50 pounds frequently and/or up to 20 pounds constantly to move objects.

Security Sensitive:

• 51.215 and Texas Government Code
• 411.094. To the extent that a position requires the holder to research, work on, or have access to critical infrastructure as defined in Texas Business and Commerce Code
• 117.001(2), the ability to maintain the security or integrity of the infrastructure is a minimum qualification to be hired for and to continue to be employed in that position. Personnel in such positions, and similarly situated state contractors, will be routinely reviewed to determine whether things such as criminal history or continuous connections to the government or political apparatus of a foreign adversary might prevent the applicant, employee, or contractor from being able to maintain the security or integrity of the infrastructure. A foreign adversary is a nation listed in 15 C.F.R.
• 791.4. Residency Requirement:

Employees must permanently reside and work in the State of Texas.