Summary

This position supports the implementation and coordination of clinical research activities within the Maternal-Fetal Medicine (MFM) division of the OB/GYN department across two affiliated hospital sites (TCH Pavilion for Women and Ben Taub Hospital). The Research Coordinator II is responsible for executing assigned clinical research protocols, including NIH-funded longitudinal studies and industry-sponsored trials, in accordance with established guidelines, timelines, and regulatory requirements.

The role involves coordinating participant-facing study activities, collecting and managing clinical data and biospecimens, and supporting multi-disciplinary collaboration required for complex maternal and pediatric follow-up studies. This position contributes to the successful conduct of multiple concurrent protocols by ensuring adherence to study procedures, maintaining data integrity, and supporting participant recruitment and retention efforts.

Job Duties

• Coordinates and implements day-to-day activities for multiple assigned clinical research protocols, including NIH-funded (CHAP Maternal and Child Follow-Up Studies) and industry-sponsored trials (PinkDx PROACTION), following established study protocols and sponsor requirements.
• Performs protocol-specific patient screening, recruitment, informed consent, and enrollment activities in outpatient, inpatient, and perioperative clinical settings, ensuring eligibility criteria are appropriately applied.
• Educates study participants on protocol requirements, visit schedules, and study procedures, adapting communication for pregnant, postpartum, and pediatric populations involved in longitudinal follow-up.
• Schedules and conducts study visits, including collection of clinical data, medical history, and protocol-required assessments through participant interaction and electronic medical record (EPIC) review.
• Performs study-related clinical procedures, including venipuncture, vital signs, anthropometric measurements, and biospecimen collection after completion of required training and competency validation.
• Processes, labels, stores, and ships biological specimens in accordance with protocol-specific laboratory manuals and regulatory requirements, maintaining accurate documentation and specimen tracking.
• Enters, updates, and maintains study data in electronic data capture systems and sponsor databases, ensuring accuracy, completeness, and timely resolution of data queries.
• Maintains study regulatory documents and files, including IRB submissions, protocol updates, adverse event documentation, and preparation for sponsor monitoring visits and audits.
• Communicates and coordinates with physicians, nursing staff, clinic personnel, and operating room teams to facilitate identification and enrollment of eligible participants and integration of study procedures into clinical workflows.
• Supports coordination of multi-disciplinary study components, including collaboration with psychology/neurocognitive assessment teams and institutional laboratories for CHAP follow-up studies.
• Assists with participant retention efforts by maintaining ongoing communication with enrolled participants and coordinating follow-up visits across extended study timelines.
• Communicates with study sponsors and monitors to support routine study management and site visits.
• Maintains required certifications and training (e.g., CITI, GCP, protocol-specific training) and ensures compliance with institutional and regulatory standards.
• Applies working knowledge of clinical research processes, medical terminology, and hospital workflows to support protocol implementation in a high-volume OB/GYN clinical environment.
• Utilizes EPIC and study-specific databases to support accurate data collection and coordination of research activities.
• Demonstrates effective communication and professionalism when interacting with diverse patient populations, including pregnant individuals and pediatric participants.
• Responds appropriately to time-sensitive clinical and research situations while maintaining adherence to protocol and patient safety standards.
• Performs other job-related duties as assigned in support of clinical research operations.

Minimum Qualifications

• Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
• One year of relevant experience.

Preferred Qualifications

• Medical Degree is preferred.
• One year of experience working in clinical trials with human subjects.
• Ability to multi-task is critical to this role.
• Experience supporting clinical research studies involving human subjects.
• Experience with biospecimen collection, processing, and handling.
• Familiarity with EPIC and electronic data capture systems (e.g., REDCap or sponsor databases).
• Strong organizational skills with the ability to manage multiple assigned protocols and competing priorities.
• Effective interpersonal and communication skills for participant interaction and team coordination.