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 (and preferably Spanish), 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.Job Duties
- Recruit, assess, enroll, schedule and monitor clinical research participants
- Liaise with the study investigators, research managers, collaborators and regulatory staff (IRB, IACUC, DSMB, NIH, FDA)
- Attend regular staff meetings and provide detailed updates and presentations
- Provide training and guidance on current and new regulations, and guidance on best practices to new coordinators, and study teams.
- Assist with building research portfolios in multiple studies
- Manage and oversee study qualification and study feasibility activities.
- Liaise with Principal Investigator (PI), study sponsor, research manager and regulatory bodies to support all aspects of study activity.
- Support the principal investigator with timely reporting of study status, enrollment status, study monitoring, adverse effects and study regulation.
- Supervise, schedules and direct less experienced lab staff in conduct of clinical research activities, and specific and specialized processes and measurements.
- Liaise with research manager and PIs for timely scheduling and coordination of visits.
- Lead and attend regular meetings with research manager, PIs, and study team for update reports and process improvement for ongoing studies.
- Follow and implement sectional, departmental and institutional standard operating procedures (SOPs).
- Perform and participate in quality control reviews of study activities and chart reviews/electronic medical records.
- Complete data collection, documentation activities and database queries, and documents and file results.
- Coordinate research protocol procedures and processes, working closely with research manager, study team, and regulatory teams on monitoring and maintaining study related information.
- Provide cross-coverage on study activities as needed. 17: Manages, leads and participates in additional projects as directed by PI.
- Order study supplements and review/monitor certificate of analyses from the manufacturer, and deliver to the dispensing pharmacist
- 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.
- Monitor compliance with study supplements, and be available for any questions or concerns.
- Collect patient information; process documents and enter information into database.
- Performs venipuncture (blood draws), obtains vital signs and other measurements as required per study protocol.
- Independently collect, process, ship, 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.
- File and maintain all relevant study data (including test results).
- Process collected samples in the lab as required in the study protocol.
- Correspond with study participants, nursing staff, other coordinators and regulatory staff.
- Supervise and train research nursing staff with all requirements of the study
- Prepare information for Data Safety Monitoring Board meetings every 6 months for the duration of the study.
- Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
- One year 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.