Summary

The Scott Department of Urology at Baylor College of Medicine in Houston, TX is seeking a Research Coordinator II to join the growing Bladder Cancer Research Center team. We are looking for an organized and detail‑oriented laboratory professional who will play a key role in supporting the research program.

This position assists with the daily operations of the tissue bank and helps maintain a safe, secure environment for all stored specimens.

Responsibilities include collecting, processing, storing, and transporting human tissue samples across Baylor College of Medicine facilities and affiliated hospitals.

The Coordinator will also support laboratory research projects within the Bladder Cancer Center, including IHC procedures and the collection of tumor, urine, and blood samples for germline analysis and potential longitudinal follow‑up studies.

Job Duties

• Obtain informed consent, screen, and enroll participants in clinical trials.
• Manage and maintain study visits, source documentation, adverse events (AEs), serious adverse events (SAEs), concomitant medication logs, as well as study subject and regulatory binders.
• Process, coordinate, and ship biological specimens (e.g., urine and blood) in accordance with protocol requirements.
• Coordinate clinical studies in compliance with sponsor protocols and timelines.
• Collaborate effectively with clinical and non-clinical teams to meet sponsor requirements.
• Collect, review, and analyze study data; perform accurate EDC data entry.
• Prepare for and support interim monitoring visits (IMVs), audits, and inspections.
• Ensure ongoing compliance with IRB and regulatory requirements.
• Partner with the Research Administration Associate on study renewals with central and local IRBs.
• Generate quarterly reports on enrollment metrics and study milestones.
• Work closely with the Principal Investigator (PI) to ensure enrollment targets and protocol compliance are achieved.
• Develop and implement SOPs aligned with clinical workflows for assigned studies.
• Establish and maintain systems to track, process, and monitor study activities.
• Perform other 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

• Experience with Pilot and Phase III/IV clinical trials.
• Familiarity with electronic medical records system.
• Experience with EDC systems (e.g., Medidata Rave).
• Prior regulatory experience.
• Strong organizational and time management skills.
• Ability to work independently and collaboratively in a team environment.
• Knowledge of urology clinical practices and procedures.
• Some of these studies involve extensive urine sample collection, patient consenting, and retrieval/printing of source documentation from prior urology records.
• Requires the ability to work collaboratively with multiple providers and coordinate across their clinics.