Position coordinates the activities of clinical trial research studies for the Pediatric Research Resources Office (RRO). Primary responsibilities include patient enrollment, screening, monitoring of research participants, and reporting to the clinical research sponsor. Responsible for ensuring accurate data collection, documentation, organization and safety of study volunteers. Position requires prior clinical research experience and able to work independently with minimal oversight.Job Duties
This position will be part of the coordination team for large clinical trials. The Research Coordinator must have the ability to communicate the study processes and procedures to the study participants.
- Clinically and administratively manages multiple studies involving rapid scale up and a high volume of patients/participants in complex clinical trials.
- Adheres to Baylor College of Medicine, Texas Children's Hospital and Clinical Research SOPs
- Adheres to FDA Good Clinical Practices outlining the standard for safety, design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials or studies
- Verifies eligibility of patients for enrollment in studies based on comprehensive inclusion and exclusion criteria outlined in the protocol
- Ensures scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials
- Discuss study protocols with patients and verifies the informed consent documentation
- Dispense study medication in a professional and accountable manner following protocol and hospital requirements
- Submits serious adverse event reporting and follow up as needed.
- Prepares documentation necessary to obtain initial and continued approval for the specific research protocol.
- Collaborates with physician, mid-level practitioners, and research nurses and data managers to document patient care.
- Conducts subject research study education as required within the scope of practice.
- Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
- Two years of relevant experience.
Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.