Senior Research Coordinator - Clinical Research

Senior Research Coordinator

Unique opportunity to provide centralized coordinator support within the Office of Clinical Research to multiple Principal Investigators 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 Office of Clinical Research research portfolio, liaising with Principal Investigators, regulatory staff, sponsor representatives, investigational pharmacy, and provides cross-coverage across the Office of Clinical Research 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 Office of Clinical Research clinical research study support as needed. Provides clinical research coordinator support for clinical trial service requests received in the Office of Clinical Research 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 Principal Investigators and departments across the College.
• Participates in study qualification, study feasibility activities and study close out activities for report to research manager.
• Liaises with Principal Investigator, Sponsor, Research Manager and Office of Clinical Research 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, Principal Investigator, Sponsor for timely scheduling and coordination of pre-site and site initiation visits.
• Attends regular meetings with Research Manager, Principal Investigators, 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 Office of Clinical Research Regulatory team on monitoring visit report findings.
• Provides cross-coverage on study activities across Office of Clinical Research as needed.
• Participates in additional projects as directed by research manager, as a central office within the Office of Research.
• 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.

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. Requisition ID: 25244

Baylor College of Medicine