UTHealth Houston's Department of Psychiatry and Behavioral Sciences is looking for a Program Manager. This employee develops, plans and manages all activities of a school/unit program(s) or project(s). Functions in a Leadership capacity in the program. Responsible for supporting clinical research activities across Human Subjects Research (HSR) studies, including delivery of operational activities as defined in the study protocol(s), clinical development plan, and to the agreed quality standards, budgets, and timelines. They will report to the Center Director.

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:

Develops, plans and manages all activities of a school/unit program(s) or project(s). Functions in a Leadership capacity in the program.

Position Key Accountabilities:

• Oversees, coordinates, and manages all aspects of the program activities. Sets deadlines, assigns responsibilities to Research Assistants/Coordinators (and other staff within the lab, as needed), and monitors project progress. Develops, implements, and manages policies and procedures.
• Coordinate the implementation of HSR protocols, administrative and logistical procedures, documentation, and operating systems according to IRB requirements and applicable regulations and standards.
• Assess operational and material requirements for HSR protocols. Plan and coordinate procurement of recruited clinical facilities, equipment, and supplies, including reimbursement of study subjects.
• Plan and carry out programs for the recruitment, screening, enrollment, and retention of clinical research subjects.
• Prepare and submit IRB initial submissions and modifications, and communicate with IRB.
• Coordinate the implementation of recruitment campaigns (including working with relevant UT-Health departments to establish and execute contracts with any outside recruitment agencies/organizations), report outcomes from each recruitment campaign to evaluate suitability of the outreach approach; research and recommend alternative strategies.
• Report outcomes on study progress (e.g., recruitment, enrollment, retention); identify bottlenecks and suggest solutions; update subject-related specific needs according to protocol amendments.
• Establish appropriate screening and data collection systems and procedures according to each protocol; oversee the collection, processing, and recording/entry of data across various platforms and in a timely manner; address data queries and discrepancies.
• Coordinate the maintenance of study records and documentation across all studies (and sites, as applicable), ensuring complete and accurate documentation as well as confidentiality of subject records.
• Oversee Quality Assurance (QA) and Quality Control (QC) strategies and prepare QA/QC reports, as requested by study PI.
• Support development, approval, and maintenance of study plans (MOPs, SOPs).
• Plan, schedule, and carry out day-to-day study activities and procedures, ensuring efficient workflow. Ensure activities are completed within established timeframes and targets.
• Prepare and submit reports (annual, progress, financial, safety, continuing reviews, etc.) to regulatory agencies, federal and state oversight organizations, data and safety monitoring boards, and study sponsors. Also prepare and submit data to NIH/NDA and other organizations, as required for each study.
• Oversee the preparation of materials/equipment required for study visits and study procedures.
• Act as the primary point of contact any study procedures completed in different facilities across UT-Health (e.g.fMRI, TMS, EEG, etc).
• Design and/or enhance databases (e.g., REDCap), data forms, and tools (e.g., calendars, schedules, tracking logs) to facilitate consent and data collection as needed per protocol.
• Support audit-readiness of delegation logs, subject binders, and regulatory binders, memos/note to files/case report forms; address insufficiencies identified by internal and/or external monitors/auditors.
• Lead internal meetings, as required (i.e., weekly lab meetings). Oversee the scheduling of meetings and the preparation and dissemination of meeting agendas, meeting minutes, etc.
• Manage and supervise Research Assistants/Coordinators (e.g., managing timecards, managing vacation schedules, staffing study visits, etc.)