Job Information
UT Health Senior Manager Clinical Trial Program (Stroke Institute) in Texas Medical Center-Houston, Texas
Senior Manager Clinical Trial Program (Stroke Institute)
Location: Texas Medical Center-Houston, Texas
Category: Research
McGovern Medical School at UTHealth Houston
Requisition #: 240001OH
Stroke Institute, located at 6431 Fannin St., Houston, Texas 77030. Exempt position.
Seeking a person experienced in human research studies, with the ability and experience to train research staff on how to manage clinical trials. This is a working leadership role in the Institute for Stroke and Cerebrovascular Disease with the expectations that the person will have good knowledge on research compliance, has experience in audits for clinical trial studies and is capable of leading internal audits on the studies. Experience with CAPA (Corrective and Preventative Action) plans and being able to oversee 8 research staff with day-to-day activities and is knowledgeable and have the ability to find resources for questions that come up from research staff. This role will be expected to assist with writing research protocols as well as be the lead in writing RFA’s for pilot studies and managing the administrative components of those pilot studies.
The person in this position will need excellent communication skills with study staff, leadership, and sponsors. Have the ability to bring groups together (both internal and external). This person will not be doing subject recruiting or enrollment but will be managing and training the staff on site development, enrollment of human subjects and clinical trial monitoring. This role will manage multiple studies and be expected to learn and know the SOP’s for each study. This is not a research administrator (pre/post award) position. Confidence, great presentation skills and strong collaborative skills are also required.
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! 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:
Manages subject recruitment, site development, enrollment of human subjects and clinical trial monitoring.
Position Key Accountabilities:
Manages all aspects of the clinical trial including but not limited to budget development, budget negotiation, coverage analysis development, contracts, regulatory compliance, and pre and post award activities. 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.
Manages collaboration with all principal investigators to implement processes and structure for conducting clinical trials by institutional guidelines.
Interacts with project teams and provide required/necessary training.
Creates annual budget, negotiate with service contracts, and reports on progress and authorizes expenditures.
Oversees and assigns responsibilities, monitors progress of the clinical trials, and provides supervision and education to research personnel, nurses and principal investigators.
Manages Human Resources activities for direct reports in regards to: recruiting and selection, hiring and termination, training, professional development, mentoring, counseling, performance evaluations, and salary planning.
Other duties as assigned.
Certification/Skills:
Depending on clinical trial, an RN registered in the state of Texas might be required.
Depending on clinical trial a Human subjects training certificate might be required.
Bilingual–English/Spanish preferred.
Minimum Education:
Bachelor’s degree. In the event that an RN degree is required, the bachelor’s degree may be waived.
Minimum Experience:
Seven (7) years of relevant experience. 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.
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 § 51.215
Residency 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 Benefits
UTHealth 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 Statement
UTHealth 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 UTHealthHoustonemployees 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.