Research Coordinator III

Summary

This position is in the Section of Endocrinology, Diabetes and Metabolism, Department of Medicine. The candidate will be working primarily in research in ongoing human clinical trials, and also participate in basic science projects in the lab to a minor extent. The position requires fluency in English, ability to work well as part of a dynamic team, willingness to learn, handle responsibility, supervise junior lab members and potential students, and assist the Principal Investigator in all the missions of his lab. In this position, you will learn techniques and operation of equipment which is required for studies. This includes phlebotomy via venipuncture, operating the Oroboros respirometer, calorimetry, endothelial function using EndoPAT and others as needed.

Job Duties

• Recruits, assesses, enrolls, schedules and monitors clinical research participants
• Liaises with the study investigators, research managers, collaborators and regulatory staff (IRB, IACUC, DSMB, NIH, FDA)
• Attends regular staff meetings and provides detailed updates and presentations
• Provides training and guidance on current and new regulations, and guidance on best practices to new coordinators, and study teams.
• Assists with building research portfolios in numerous studies
• Manages and oversees study qualification and study feasibility activities.
• Liaises with Principal Investigator (PI), study sponsor, research manager, regulatory bodies and research finance to support all aspects of study activity.
• Supports the investigators with timely reporting of study status, enrollment status, study monitoring, adverse effects and study regulation.
• Supervises, schedules and directs less experienced research coordinators in conduct of clinical research activities, and specific and specialized processes and measurements.
• Liaises with research manager and PIs for timely scheduling and coordination of visits.
• Leads and attends regular meetings with research manager, PIs, and study team for update reports and process improvement for ongoing studies.
• Follows and implements sectional, departmental and institutional standard operating procedures (SOPs).
• Performs and participates in quality control reviews of study activities and chart reviews.
• Completes data collection, documentation activities and database queries, and documents and files results.
• Coordinates research protocol procedures and processes, working closely with research manager, study team, and regulatory teams on monitoring and maintaining study related information.
• Provides cross-coverage on study activities as needed.
• Manages, leads and participates in additional projects as directed by PI.
• Order study supplements and review/monitor certificate of analyses from the manufacturer.
• Order study supplement capsules from the dispensing pharmacist, and collect and and deliver it to study participants.
• Independently calibrate and run all required equipment in the conduction of studies (including but not limited to the Oroboros high-resolution respirometer, indirect calorimeter and EndoPAT).
• Monitor compliance with study supplements, and be available for any questions or concerns.
• Collects patient information; process documents and enter information into database.
• Performs venipuncture (blood draws), EKGs/ECG's and obtain vital signs, calorimetry, endothelial testing and other measurements as required in study participants.
• Independently collects, processes, ships, and maintain paperwork for blood and/or biological specimens as needed for conduction of studies.
• Maintain records and regulatory documents and records for research studies.
• Schedule research participants for tests and procedures such as laboratory tests, x-rays, and other studies specific for the research protocol.
• Files and maintain all relevant study data (including test results).
• Processes collected samples in the lab, as required in the study protocol.
• Correspond with study participants, nursing staff, other coordinators and regulatory staff.
• Supervises and trains research nursing staff with all requirements of the study
• Prepares information for each Data Safety Monitoring Board meeting every 6 months for the duration of the study.

Minimum Qualifications

• Education Required: Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
• Experience Required: Two years of relevant experience.
• Certification/Licenses/Registration: None Required.

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.

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CA; SN