Clinical Trial Program Manager, Neurology (Neurogenetics)

Clinical Trial Program Manager, Neurology (Neurogenetics)

Location: Texas Medical Center-Houston, Texas

Hot

Category: Research

McGovern Medical School at UTHealth Houston

Requisition #: 230001QR

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:

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

Full time exempt position located in Neurology (Neurogenetics)

Apply advanced regulatory, compliance and project management knowledge to established large-scale multi-center clinical research projects lead by the Center for Neurogenetics of the McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth Houston). The Clinical Trial Program Manager is responsible for supporting the Center for Neurogenetics; managing the development, quality control and enhancement of research protocol documents to IRB submission and manage the execution of multi-center neurogenetic human subject research studies and clinical trials after regulatory approval.

This position is the primary point person responsible for the collaboration / navigation with the Center for Neurogenetics and IRB contacts, compliance and project manager from collaborating hospitals, patient organizations and clinical trial sponsors. The Clinical Trial Program Manager is responsible for closely managing regulatory submissions and communication following a quality control program that ensures study documents are of the highest quality to decrease or eliminate questions/conditions that hold up the approval and activation processes. This position mitigates inconsistencies within study documents, keeps protocols and amendments, as necessary, on track, and ensures appropriate quality control strategy at each step throughout the protocol life cycle. The Clinical Trial Program Manager also works collaboratively with other Clinical Trial Program Manager colleagues to share best practices, workload metric and training / professional development initiatives for regulatory coordinators. The Clinical Trial Program Manager is a content expert regarding regulatory requirements and processes.

It is preferred that candidates have at least 5 years of experience in protocol development, clinical research and regulatory coordination. Experience in an academic institution is preferred.

POSITION KEY ACCOUNTABILITIES:

• Meet regularly with the program leadership / key stakeholders to identify, prepare, and ensure quality and regulatory compliance and completeness of all IRB submissions.

• Assist the principal Center Director in developing protocol budgets and agreements (i.e. confidentiality, material transfer, clinical trial) in collaboration with Research Administration, Committee for the Protection of Human Subjects Office, Legal, and the Sponsored Projects Administration (SPA).

• Responsible for managing collaborations with partnering institutions and organizations in executing the multi-center clinical research studies and clinical trials.

• Assist in the oversight of the Neurogenetic Centers clinical trial portfolio and all related regulatory and compliance metrics requirements. Maintains knowledge of neurological disorders, genetics and the clinical trial process.

• Identify and manage operational, logistical, and regulatory challenges related to the start-up, active, and closeout phases of the research study and clinical trial life cycle and act as a leader in overseeing their resolution.

• Assists PI and study team with protocol development, consent form development, and initial application and collaborate with the study team to develop study case report forms, database information, and to establish guidelines for monitoring data quality control for PI Initiated studies / Multi-Center Trials.

• Create and maintain tracking for all subsequent submissions to the IRB; protocol & consent amendments, all required safety reporting, all required deviation, violation, exception, or other event reporting, as needed. Ensure various regulatory reporting required are met, Study Sponsor, FDA, IRB etc.

• Serve as facilitator for study team and sponsor regarding study status information, critical safety issues, upcoming protocol, consent and IDB amendments, as necessary, and applicable protocol training.

• Other duties as assigned.

Position Key Accountabilities:

1. Oversees all aspects of the clinical trial. Identifies and evaluates programs, companies, universities/colleges, etc.., where large populations of potential subjects reside.

2. Identifies, develops, and maintains suitable site(s) for on-going trial visits.

3. Develops and implements presentations/recruiting initiatives for clinical trials including presenting to potential trial subjects.

4. Maintains regular communication with clinical sites, investigators, subcontractors, and/or pharmaceutical companies.

5. Interacts with project teams and provide required/necessary training.

6. May create annual budget, negotiate with service contracts, and reports on progress and authorizes expenditures.

7. 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.

8. 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.

Preference:

Very proficient knowledge of and ability to execute clinical trials start-up, active and close out phases.

Very proficient knowledge of clinical research local policy and federal regulation.

Proficient knowledge of regulatory affairs, research ethics and the responsible conduct of research.

Excellent organizational skills and attention to detail.

Excellent written and verbal communication and interpersonal skills.

Strong ability to work independently and with little direction, and balance multiple projects and tasks simultaneously.

Strong ability to both work as a member of and effectively and proactively collaborate with multiple teams.

Strong ability to identify and assist in managing personnel issues and to provide critical feedback to supervisees, when applicable.

Ability to lead multiple projects simultaneously.

Ability to prepare, with minimal supervision, a summary of a clinical trial design, objectives and activities using established guidelines and governmental regulations in a clear, concise, and health-literate format.

Ability to easily identify complex regulatory scenarios and independently develop viable solutions to present to supervisor.

Minimum Education:

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

Minimum Experience:

Five (5) years of relevant experience. Pharmaceutical or clinical research strongly preferred.

Preference:

• Bachelor’s degree in Biology, Life Sciences, or related field required.

• 5 years of experience in clinical research and regulatory coordination required; 3 years of experience with a Master’s in related field.

• Experience in protocol development.

• Experience in an academic institution 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 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.