Research Coordinator II - Medicine - Gastroenterology and Hepatology (Houston, TX, US) @ Baylor College of Medicine Prod

• Summary The Department of Medicine, Section of Gastroenterology and Hepatology, is looking for a Research Coordinator II to manage the day to day operations of multiple research projects for Dr. Mimi Tan . The ideal candidate will manage patient screening, recruitment (consenting and enrollment), data collection (administering patient questionnaires surveys, conducting chart reviews of electronic medical records) and data management (electronic database development, data entry, data monitoring, data reporting and analyses).
• The RC II will manage blood processing, storage, and shipping.
• The RC II will assist with IRB submissions (drafting protocols, amendments, renewal reports, adverse events, closeouts), and award reporting (NIH RPPR, etc.).
• The RC II will draft and manage clinical study documents: case report forms, informed consent forms, standard operating procedures, other templates and documents as needed.
• Job Duties Screens GI clinic and endoscopy schedules and the EMR against protocol eligibility criteria for Dr. Tan’s studies, then approaches, educates and consents eligible patients (e.g., those undergoing upper endoscopy for known or suspected of target disease).
• 20% Gives participants study questionnaires and surveys, pulls clinical, endoscopy and pathology data from the EMR, and enters and quality-checks data in REDCap; records vital signs when the protocol requires.
• 20% Collects, processes (centrifuge, aliquot), labels, stores and ships research blood/tissue specimens on dry ice, keeping specimen inventory and chain-of-custody records.
• 10% Completes BCM phlebotomy training, IATA shipping certification, and CITI/GCP/HIPAA training before performing study procedures.
• 5% Keeps regulatory binders for each study (IRB approvals, consent versions, delegation and training logs, deviations) and tracks continuing review deadlines in BRAIN.
• 5% Schedules study visits, research blood draws and follow-ups around participants’ clinical endoscopy appointments, working with endoscopy unit and pathology staff.
• 10% Is the main participant contact from recruitment through follow-up, handling outreach, consent, reminder calls, follow-up surveys at protocol intervals, return of results, and participant compensation (if applicable).
• 5% Retrieves endoscopy and pathology reports from the EMR, sends them to Dr. Tan and collaborators, and flags clinically significant findings to the PI.
• 5% Orders and tracks study supplies (specimen kits, shipping materials, printed materials) and reconciles purchases against the study budget.
• 5% Coordinates with partner sites on recruitment progress (if applicable), equipment and device shipments, and data and specimen transfers.
• 5% Before each procedure day, confirms consent and eligibility, prepares specimen kits and CRFs, and checks that study equipment [e.g., imaging device] is ready.
• 5% Performs other job duties as assigned.
• 5% Other IRB submissions: Drafts new protocols, amendments, continuing reviews, reportable event and adverse event submissions, protocol deviations and closeout reports in BRAIN and VA R&D Committee, (if applicable).
• Tracks submission status and handles IRB requests for changes.
• Study document development: Drafts and revises informed consent forms using BCM IRB templates, case report forms, SOPs, recruitment materials, screening and eligibility checklists, and other study templates.
• Coordinates Spanish translation of participant-facing materials.
• Database development and management: Builds and maintains REDCap projects for each study, including instruments, branching logic, field validation, data dictionaries and user access.
• Runs regular data monitoring and cleaning reports.
• Data reporting and analysis: Prepares enrollment and data summary reports for weekly team meetings.
• Runs descriptive analyses (frequencies, summary statistics, tables) to support Dr. Tan’s abstracts, manuscripts and grant applications.
• Award reporting: Helps prepare NIH progress reports (RPPR), including progress summaries and inclusion enrollment reports, and tracks study milestones against the grant timeline.
• Keeps ClinicalTrials.gov registrations current when required.
• Compliance: Makes sure study conduct follows the protocol, GCP, HIPAA and BCM policy.
• Documents and reports deviations and carries out corrective actions.

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

• Master's of Public Health Two-Three years of 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.