Summary

The position will serve as the Clinical Research Lead for community-based research trials at Texas Children’s Hospital, West Campus, overseeing the clinical and administrative operations of clinical research studies, including study initiation, implementation, and coordination, for the Center for Research Advancement (CRA) in the Department of Pediatrics.

The Clinical Research Lead will be responsible for ensuring accurate data collection, documentation, organization and safety of study volunteers. Responsibilities will also include patient enrollment, screening, monitoring of research participants, and reporting to the clinical research sponsors, ensuring scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials.

This position will be working directly with physicians and investigators to review treatment protocols and follow up on study patients. Candidates must have a working knowledge of FDA Good Clinical Practices, and the ability to read, analyze, and interpret information.

Travel to Texas Children's Hospital-Texas Medical Center may be required for training and other centralized activities. 

Applicants must be willing to work in a fast-paced setting, comfortable working in a team environment, and possess excellent communication skills. 

Must be a self-starter, effective communicator and able to manage multiple multi-site clinical trials with limited or minimal supervision.

Job Duties

CRA Operations Lead / Study Start-Up and Feasibility – 20%

• Serves as the primary CRA operations lead for clinical research programs at Texas Children’s Hospital, The Woodlands.
• Collaborates with CRA leadership, investigators, research managers, and sponsors to evaluate new research opportunities and support study feasibility, qualification, and start-up activities.
• Develops operational workflows and implementation plans for complex studies requiring multidisciplinary coordination.
• Coordinates start-up activities, including budget development and institutional reviews, in partnership with CRA Clinical Trial Finance, CRA Grants and Contracts, and study sponsors.

Clinical Trial Management and Subject Visits – 30%

• Independently manages multiple clinical research studies and ensures timely execution of protocol-required activities.
• Screens, recruits, enrolls, and educates research participants and families regarding study requirements.
• Conducts or supports the informed consent process and confirms participant eligibility in accordance with protocol requirements.
• Coordinates participant visits, procedures, laboratory testing, and follow-up activities.
• Collects, processes, stores, and ships biological specimens in accordance with study protocols and applicable guidelines.

Data Collection, Documentation, and Regulatory Coordination – 20%

• Collects and documents study data through participant interviews, questionnaires, medical record review, and other protocol-required sources.
• Maintains source documentation, case report forms, study databases, and regulatory files to ensure accuracy and compliance.
• Collaborates with investigators, research staff, and the CRA Regulatory team to support informed consent development, regulatory submissions, and ongoing compliance activities.
• Ensures study documentation and records meet sponsor, institutional, protocol, and regulatory requirements.

Protocol Development, SOPs, Training, and Study Closeout – 15%

• Supports protocol submissions and prepares documentation for initial and continuing regulatory approvals.
• Develops, implements, and maintains CRA standard operating procedures and study workflows.
• Leads study closeout activities, including documentation review, record retention, and end-of-study reporting.
• Prepares studies for monitoring visits, audits, sponsor reviews, and regulatory inspections.
• Provides training, mentorship, and day-to-day guidance to junior research staff and less experienced team members.

Communication with Sponsors, Investigators, Participants, and CRA Leadership – 15%

• Serves as the primary point of contact for study-related communication among investigators, sponsors, participants, clinical teams, and CRA leadership.
• Provides input on study assignments, operational priorities, resource needs, and research activities.
• Facilitate communication and issue resolution across departments and participating sites.
• Reports adverse events and other required study updates in accordance with protocol, sponsor, and institutional requirements.
• Performs other job-related duties as assigned.

Minimum Qualifications

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

Preferred Qualifications

• Advanced degree in a scientific, health-related, public health, research administration, or clinical research field.