Job Description

Summary

The Office of Surgical Research (OSR) within the Michael E. DeBakey Department of Surgery has an immediate opening for a Clinical Research Coordinator II with the Thoracic Surgery Team. The Coordinator will conduct the day-to-day activities of clinical research protocols. This role focuses on the screening, enrollment, and monitoring of research participants to ensure accurate data collection and participant safety. The Coordinator will support both interventional and observational trials.

Job Duties

Participant Coordination & Care – 50%

• Interviews, screens, and recruits patients for thoracic surgery studies; explains study procedures and educates participants.
• Consents and enrolls eligible participants, ensuring compliance with protocols and ethical standards.
• Schedules participants for study-related tests and procedures, such as laboratory work, imaging, and other protocol-specific assessments.
• Engages with research participants to provide ongoing education, conduct interviews, and ensure study retention.
• Obtains vital signs on study participants. With appropriate credentialing and training, may perform phlebotomy, specimen collection, ECGs, or other procedures.
• Collects, processes, stores and ships biological specimens in accordance with protocol and IATA regulations.
• Coordinates with pathology, laboratories, biobanks, and central laboratories as needed.

Clinical Data & Trial Support – 30%

• Reviews protocols, study manuals, and other study-specific materials and implements requirements into daily workflows.
• Develops and maintains study-specific tracking tools, calendars, and logs.
• Collects, processes, documents, and enters participant data into research databases accurately and on time; may perform data management tasks for assigned research projects.
• Maintains study-specific source documents and regulatory records (Regulatory Binder/Essential Documents).
• Ensures current approved consent forms, protocols, and study materials are available for use.
• Retrieves and submits test results to the Principal Investigator (PI) or appropriate clinical parties.
• Identifies and escalates potential protocol deviations, safety concerns, and other study issues, including SAE reporting.
• Reviews case report forms, audits for accuracy against source documents, and participates in monitoring visits with study sponsors.

Operational Support – 20%

• Coordinates day-to-day activities of research protocols in collaboration with surgical and nursing teams.
• Serves as the primary point of contact for study-related operational questions.
• Assists with study start-up for low to moderate complexity clinical trials.
• Orders necessary supplies and equipment to ensure study continuity.
• Corresponds with patients throughout the duration of the study to ensure compliance with study visits.
• Performs other job-related duties as assigned.

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

• Bilingual in Spanish.
• Clinical research experience.

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.