Manager, Clinical Research - Pediatrics - Center for Research Advancement Administration

Baylor College of Medicine; Texas; Hybrid; USD 99,000 - 117,000; Full time

Job summary

Baylor College of Medicine in Houston, TX, seeks a Manager of Clinical Research in Pediatrics to lead Neurology studies within the Center for Research Advancement (CRA). The role oversees coordinators and data managers, ensuring compliant, on-time study execution and high-quality data collection.

The candidate will guide SOP development, staff mentorship, and collaboration with Principal Investigators to optimize electronic data capture systems while maintaining patient safety and regulatory

Qualifications

• Bachelor's degree required.
• Four years of relevant clinical research experience.
• Advanced degree in science/PH/Clinical Research preferred.
• CRP/CRC certification from SoCRA or ACRP preferred.
• Willing to lift 20-30 lbs.

Responsibilities

• Oversee day-to-day clinical research operations for Neurology studies.
• Lead CRA Neurology team including coordinators and data managers.
• Ensure SOPs and GCP adherence; manage resources and scheduling.
• Develop and optimize electronic data capture systems.
• Mentor staff and provide performance feedback.
• Ensure patient safety and regulatory compliance.

Skills

Leadership

GCP knowledge

FDA regulations

Supervisory experience

Project management

Education

Bachelor's degree

Advanced degree

Tools

Electronic data capture systems

Job description

Manager, Clinical Research - Pediatrics - Center for Research Advancement Administration

Division: TCH Departments | Work Arrangement: Hybrid | Location: Houston, TX | Salary Range: $99,213 - $116,721 | FLSA Status: Exempt | Work Schedule: Monday – Friday, 8 a.m. – 5 p.m.

Summary

Responsible for overseeing and directing the day-to-day clinical research operations of the Neurology research team within the Center for Research Advancement (CRA), Department of Pediatrics. Provides leadership and supervision to CRA Neurology research coordinators, ensuring efficient planning, recruitment, and execution of assigned clinical studies. Manages all aspects of study coordination, compliance, data collection, and documentation. Ensures adherence to study protocols, timelines, and quality standards while fostering collaboration across multidisciplinary teams.

Takes a lead role in advancing the department’s clinical research mission at Baylor College of Medicine. Provides strategic oversight and operational leadership for therapeutic clinical research studies, directly impacting patient safety and research quality. Supports Principal Investigators in the successful execution of funded studies, contributing to departmental research funding and improved clinical outcomes. Drives excellence in research operations through mentorship, study oversight, compliance, and process optimization.

Occasional work on the weekends and after hours may be required.

Job Duties

• Manages complex therapeutic research studies across multiple protocols for the Division of Neurology within the Center for Research Advancement (CRA).
• Oversees a team of clinical research professionals, including research coordinators and data managers, ensuring balanced workloads and high-quality performance.
• Leads planning and scheduling of study activities for direct reports; provides strategic input to leadership on resource allocation, recruitment strategies, study assignments. and other key study activities.
• Provides daily oversight, coaching, and performance feedback to staff, ensuring adherence to CRA Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP) guidelines.
• Conducts performance evaluations and manages administrative actions for team members, supporting their professional development.
• Designs and delivers training on sample processing, storage, and shipment procedures to ensure protocol compliance and data integrity.
• Directs day-to-day operations for multiple concurrent clinical studies, ensuring timelines, safety, and regulatory requirements are met.
• Ensures subject safety and protocol fidelity by overseeing study conduct in alignment with regulatory and institutional standards.
• Leads the development of study tools, including Manuals of Operations, source documents, and study orders, to support accurate and efficient data collection.
• Mentors junior staff in study startup processes, including multi-center trial coordination.
• Collaborates with Principal Investigators to develop and optimize electronic data capture systems.
• Authors and reviews Standard Operating Procedures (SOPs) to enhance operational efficiency and compliance.
• Oversees reporting and compliance activities, ensuring timely submissions and audit readiness.
• Performs additional duties as assigned to support CRA and departmental goals.

Minimum Qualifications

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

Preferred Qualifications

• Advanced degree (e.g., Master’s in the field of science, Public Health, Clinical Research, or related field).
• Minimum of four (4) years of experience in clinical trials or clinical research.
• Demonstrated experience managing clinical study assignments and/or supervising clinical research staff.
• Strong knowledge of Good Clinical Practice (GCP), FDA regulations, and institutional research policies.
• Certification as a Clinical Research Professional (CRP) or Clinical Research Coordinator (CRC) from: Society of Clinical Research Associates (SoCRA), or Association of Clinical Research Professionals (ACRP).
• Willing to lift 20-30 lbs

Work Authorization Requirement

Work Authorization Requirement:

This position is not eligible for visa sponsorship. Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

Baylor College of Medicine fosters diversity among its students, trainees, faculty, and staff as a prerequisite to accomplishing our institutional mission and setting standards for excellence in training healthcare providers and biomedical scientists, promoting scientific innovation, and providing patient-centered care.