Clinical Trial Program Manager - Coordinating Center for Clinical Trials

Clinical Trial Program Manager - Coordinating Center for Clinical TrialsLocation: Texas Medical Center-Houston, TexasHotCategory: ResearchUTHealth Houston School of Public HealthRequisition #: 2400007KWhat 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.We are looking for a Full-Time Clinical Trial Program Manager to join The Coordinating Center for Clinical Trials (CCCT) as part of the UTHealth School of Public Health in Houston, TX, 77030. The Coordinating Center for Clinical Trials (CCCT) provides full-service trial coordination for research studies. The CCCT handles the logistical and statistical challenges of coordinating small and large multicenter studies and research projects, from study design and execution to the dissemination of trial findings. In this position, you will provide day-to-day administrative project management support to Investigators on multiple studies and may give scientific direction for research projects of considerable scope and complexity. This will include planning, coordinating, and conducting the research and administrative services that support the activities of the center. This is a Hybrid position.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! As a world-renowned institution, our employees’ wellbeing is important to us. We offer work/life services such as

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. Provides day-to-day administrative project management on multiple studies and may provide scientific direction for research projects of considerable scope and complexity. Primary activity includes planning, coordinating, and conducting the research and administrative services that support the activities of the Coordinating Center for Clinical Trials (CCCT).Position Key Accountabilities:

Provides project management for multiple clinical trials. This includes management of annual budgets, personnel, and training to meet target milestones and study objectives.

Manages the development process for protocols and study materials for clinical trials.This includes interaction with all study stakeholders and development of specifications and timelines.

Provides oversight of the accuracy and integrity of data in collaboration with data managers.This includes the generation of programming request for specific forms, reports, quality control checks, etc. to be created in the electronic data capture system.

Attend all project meetings to actively participate in the planning and management of new & ongoing studies.This includes setting the agenda, outlining deliverables, and delegation of assignments to supervisees and other team members.

Manages regulatory duties for clinical trials. This includes IRB submissions, ClinicalTrials.gov registration, supervision of project team required trainings, and other project-specific regulatory activities.

Leads preparation of progress reports and grant proposals to funding agencies.This includes working closely with the pre- and post-award teams and the Office of Sponsored Projects on timely submission of required documents.

Manages contracts with vendors/core labs/industry partners and assists with developing associated scope of work and related training materials. This includes review/modification of these documents to meet study objectives.

Manages Human Resources activities for direct administrative reports.This includes recruiting and selection, hiring and termination, training, professional development, mentoring, counseling, performance evaluations, and salary planning.

Other duties as assigned.

Preferred Certification/Skills:

Bilingual – English/Spanish preferred.

Certification from the Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), Research Administrators Certification Council (RACC), Certified IRB Professional (CIP) or, Regulatory Affairs Certification (RAC).

Minimum Education:

Bachelor's degree in a related field or relevant experience in lieu of education.

Minimum Experience:

Five (5) years of relevant experience. Pharmaceutical or clinical research is 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.This position may include work involving potentially hazardous chemical, biological or radioactive agents.Security Sensitive:This job class may contain positions that are security sensitive and thereby subject to the provisions of Texas Education Code § 51.215Residency Requirement:Employees must permanently reside and work in the State of Texas.If you are looking for a great healthcare career in Houston, visithttp://go.uth.edu/careers!University of Texas Health Science Center at Houston (UTHealth)Established in 1972 by The University of Texas System Board of Regents, The University of Texas Health Science Center at Houston (UTHealth) is Houston’s Health University and Texas’ resource for health care education, innovation, scientific discovery and excellence in patient care. The most comprehensive academic health center in the UT System and the U.S. Gulf Coast region, UTHealth Houston is home to schools of biomedical informatics, biomedical sciences, dentistry, nursing and public health and the John P. and Kathrine G. McGovern Medical School. UTHealth Houston includes The University of Texas Harris County Psychiatric Center, as well as the growing clinical practices UT Physicians, UT Dentists and UT Health Services. The university’s primary teaching hospitals are Memorial Hermann-Texas Medical Center, Children’s Memorial Hermann Hospital and Harris Health Lyndon B. Johnson Hospital.UTHealth BenefitsUTHealth Houston offers a comprehensive and competitive benefits package. For more information on our benefits programs please refer to the UTHealth Houston Office of Benefits Website.https://www.uth.edu/benefits/Equal Employment Opportunity StatementUTHealth Houston is committed to providing equal opportunity in all employment-related activities without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, genetic information, gender identity or expression, veteran status or any other basis prohibited by law or university policy. Reasonable accommodation, based on disability or religious observances, will be considered in accordance with applicable law and UTHealth Houston policy. The University maintains affirmative action programs with respect to women, minorities, individuals with disabilities, and eligible veterans in accordance with applicable law.UTHealthHoustonhas adopted a policy consistent with CMS regulations to protect our patients and university community from exposure to COVID-19. This policy affects all employees, residents, fellows, students, contractors, new hires, visiting scholars program participants, adjunct faculty, and volunteers who work, train, or collaborate at the John S. Dunn Behavioral Science Center.In addition, all UTHealthHouston​​​​​​​employees who are assigned to work at a location that is subject to the affiliated partner’s hospital, clinical offices, or agency are required to abide by UTHealth’sHoustonrules and regulations, as well as the affiliate’s rules and regulations, including COVID-19 vaccination and safety requirements.Work location is based on the needs of the department and may be adjusted.