Research Program Management Associate

Summary

The Research Program Management Associate supports the planning, implementation, and day-to-day management of the Fetal Center Research Program at Baylor College of Medicine and Texas Children's Hospital. The position supports a complex portfolio of clinical research initiatives, including FDA-regulated investigator-initiated device studies, first-in-human fetal interventions, multicenter data registries, randomized clinical trials, and other prospective and retrospective research studies. The role works closely with investigators, research administration, regulatory personnel, clinical teams, and institutional stakeholders to support study startup, program implementation, regulatory operations, and quality initiatives. Serving as a key liaison across multiple departments and specialties, the Research Program Management Associate helps ensure research activities are operationalized efficiently, project milestones are achieved, and program objectives are successfully executed.

Job Duties

Research Program Planning, Implementation & Management (35%)

• Supports the planning, implementation, and day-to-day management of the Fetal Center Research Program, which includes a portfolio of more than 50 active IRB protocols.
• Develops and maintains project plans, implementation timelines, operational workflows, and tracking systems for clinical research studies.
• Tracks study startup activities, project milestones, deliverables, and key priorities across a diverse research portfolio.
• Partners with investigators and stakeholders to translate research goals into structured implementation plans and actionable project timelines.
• Provides project updates, reports, and program summaries to research leadership and stakeholders.

Study Startup, Regulatory Operations & Program Support (25%)

• Supports operational aspects of study startup, including implementation planning, startup meetings, activation timelines, stakeholder engagement, and milestone tracking.
• Partners with the Regulatory Affairs Specialist to support FDA, IRB, and institutional regulatory activities across the research portfolio.
• Works closely with the OB/GYN Research Administration team regarding agreements, contracts, and budget development to support timely study activation.
• Facilitates resolution of operational barriers impacting study startup, regulatory milestones, or project implementation.
• Supports feasibility and site selection activities as needed.

Quality Assurance, Compliance & Process Improvement (20%)

• Leads quality assurance initiatives to strengthen research quality, compliance, and operational efficiency.
• Conducts routine reviews of study documentation, workflows, and operational processes and implements corrective actions when necessary. •
• Supports audit and inspection readiness activities across the research portfolio.
• Develops and maintains standard operating procedures, tracking tools, and operational documentation.
• Identifies and implements process improvements to enhance program performance and communication.

Stakeholder Engagement & Program Administration (15%)

• Serves as a primary liaison among investigators, research administration, regulatory personnel, clinical teams, and institutional stakeholders.
• Facilitates engagement among collaborators representing multiple departments and specialties across Baylor College of Medicine and Texas Children's Hospital.
• Supports communication related to project implementation, timelines, risks, and program priorities.
• Prepares reports, presentations, and other materials for leadership, sponsors, and stakeholders.
• Supports special projects and strategic initiatives related to growth and advancement of the Fetal Center Research Program.

Training, Infrastructure & Resource Support (5%)

• Supports development and maintenance of research program infrastructure, workflows, and documentation systems.
• Assists with onboarding, training, and operational support of research personnel.
• Maintains program documentation, policies, procedures, and project records.
• Manages research equipment, supplies, and other operational resources.
• Performs other job duties as assigned.

Minimum Qualifications

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

Preferred Qualifications

• Experience with FDA Sponsor-Investigator Initiated Trials
• Familiarity with EPIC/EMR
• Proficiency with Microsoft Excel software and REDCap database
• Working knowledge of central and local IRBs such as WIRB, Advarra etc
• Previous experience in obstetrics