Summary

Unique opportunity to provide centralized coordinator support within the Office of Clinical Research (OCR) to multiple Principal Investigators (PIs) across the College and its affiliates.  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 OCR 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. Research Coordinator might be asked on rare occasion to work after hours/weekend (outside of Monday-Friday, 8:00 am to 5:00 pm).

Participates in additional projects as directed by research management as a central office within the Office of Research.  Provides cross-coverage across OCR clinical research study support as needed.  Provides clinical research coordinator support for clinical trial service requests received in the OCR for study support across the College.  Assists in research coordinator skillset trainings across the College.  

Standard work hours are Monday through Friday, 8:00 a.m. to 5:00 p.m. Occasional schedule flexibility is required, including the ability to begin as early as 6:00 a.m. or extend the workday until 8:00 p.m., with schedules adjusted as needed. Additionally, periodic after-hours and weekend work may be required.
 

Job Duties

• Recruits, schedules and conducts 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, study feasibility activities and study close out 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.
• Provides cross-coverage across OCR clinical research study support as needed.
• Performs other job-related duties as assigned.

Minimum Qualifications

• Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
• Five years of relevant experience.

Preferred Qualifications

• Bachelor’s degree (BS/BA) or higher strongly preferred (Master’s degree a plus).
• Professional certification such as CCRC (ACRP) or CCRP (SoCRA) preferred.
• Experience with both drug (pharmaceutical) and/or medical device clinical trials.
• Proficiency speaking and/or writing Spanish to support diverse patient populations.
• Experience performing blood draws (phlebotomy) in a clinical or research setting.
• Familiarity with IATA guidelines for specimen handling and shipping.
• Demonstrated ability to manage **patient-facing study.