Summary

The Research Program Manager/Lead, Clinical Research assists with oversight and provides support for the administrative and financial operations of a research program in the Texas Children's Cancer Center, Baylor College of Medicine Department of Pediatrics. This involves participation in pre- and/or post-award grant management activities, as well as clinical trial and programmatic management.

Job Duties

• Assists with oversight and provides support for the administrative and financial operations of a research study or clinical trial.
• Participates in pre- and/or post-award grant management activities.
• Assists with contract and agreement negotiations.
• Ensures time and effort is entered each pay period.
• Certifies data in BRAIN is accurate.
• Monitors compliance with federal regulations and standard operating procedures.
• Prepares IRB submissions, amendments, and renewals.
• Collects regulatory documents and maintains regulatory files.

Performs these related tasks for several programs in the Cancer Center, including Epidemiology, Leukemia, Developmental Therapeutics and others: 

• Manage the business and research admin operations of the multiple programs in the Oncology section of the Cancer Center, including Solid Tumor, Lymphoma and Histiocytosis. 
• Prepares grant support support documents and reports related to research or philanthropy funding for employee effort changes to recommend actions to Assistant Director, Oncology
• Provides administrative guidance as it relates to NIH and relevant research policies and guidelines (institutional federal, state) to Program Director(s) as necessary.
• Drafts position descriptions and recruit personnel for these programs.
• Manages program expenses to margin and to the appropriate cost center.
• Prepares expense reports, and annual reports to donors, foundations and granting agencies as part of financial management of philanthropy and grant funds including.
• Assists in developing the programs' annual budget by cost centers and forecasts revenue and expenses.
• Presents financial information, including budgets and forecasting of revenue to Assistant Director, Director & program faculty.
• Supervises office support staff (admin coordinator, laboratory manager) and directs their work activities.
• Maintains knowledge of institutional, state and federal guidelines that govern clinical research and research administration, and educates new staff during onboarding process. Communicates changes to regulations and guidelines to staff.
• Ensures that all internal personnel activities meet college and organizational objectives in training, recruitment, equal pay, equal opportunity, transfer and promotion.
• Develops business plans for new and existing operations.
• Provides guidance and direction to program plans through the management of scope, budget, timeline, risks, issues, and resources for large-scale project teams. 
• Prepares program plans, presentations and process maps for each program and for their respective strategic goals.
• Analyzes program goals, plans schedule of deadlines for completion, and develops action plan and processes for project completion from inception to evaluation.
• Coordinates program activities, assigns tasks and provides guidance to personnel responsible for specific functions or phases of the project.

Minimum Qualifications

• Bachelor's degree.
• Six years of relevant experience.

Preferred Qualifications

• Experience in research or research administration.