Summary

Within the office of Clinical Research (OCR), the Clinical Research Center (CRC) provides centralized support to Investigators who conduct a variety of clinical studies at Baylor College of Medicine (Baylor) and/or affiliated hospitals. Position supports clinical trial support on both therapeutic drug and device trials in varying disease areas with multiple departments. This role is essential for coordination of the CRC research portfolio, liaising with PIs, regulatory staff, sponsor representatives, investigational pharmacy, and provides cross-coverage across the OCR team. Position supports clinical research trial support across BCM and its affiliates in both hospital-based in-patient as well as outpatient clinical study units. The ideal candidate for this position will occasionally be required to work after hours, weekends, and overnight, and travel between BCM and affiliated hospitals within Houston Texas Medical Center.

Job Duties

• Collects, process, ships and maintian paper work for blood and biological specimen according to procedures outlines in study.
• Assists with recruiting, scheduling and conducting the daily activities of clinical research participants, liaising with investigators and regulatory staff.
• Attends regular staff meetings; provides training and guidance on regulations and best practices to new coordinators.
• Assists with research portfolios for numerous PIs and departments across the College.
• Participates in study qualification and study feasibility activities for report to research manager.
• Liaises with PI, Sponsor, Research Manager and OCR Research Finance to support all aspects of study activity.
• Supports research manager and investigators with timely reporting of study status, enrollment status, study monitoring, and site visits.
• Liaises with Research Manager, PI, Sponsor for timely scheduling and coordination of pre-site and site initiation visits.
• Attends regular meetings with Research Manager, PIs, and study team for update reports and process improvement.
• Follows departmental and institutional standard operating procedures (SOPs). Participates in quality control reviews of study activities and chart reviews.
• Completes data collection, documentation activities and database queries.
• Coordinates research protocol procedures and processes, working closely with Research Manager, study team, and OCR Regulatory team on monitoring visit report findings.
• Provides cross-coverage on study activities across OCR as needed.
• Participates in additional projects as directed by research manager, as a central office within the Office of Research.

Minimum Qualifications

• High School diploma or GED.
• Three years of relevant experience.

Preferred Qualifications

• Bachelor's degree in a related field.