Senior Research Coordinator - Clinical Research

Baylor College of Medicine; Houston (TX); On-site; USD 71,000 - 83,000; Full time

Job summary

Baylor College of Medicine in Houston, TX is seeking a Senior Research Coordinator in the Clinical Research Division to provide centralized coordination across multiple Principal Investigators and trials, including therapeutic drug and device studies.

This onsite role supports study activity with regulatory staff, sponsors, and the OCR team; requires a BS in Basic Science or related field and five years of experience, with occasional after-hours work as needed.

Qualifications

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

Responsibilities

• Recruits, schedules and conducts daily activities of clinical research participants with investigators and regulatory staff.
• Attends staff meetings; provides training on regulations and best practices to new coordinators.
• Participates in study qualification, feasibility activities and close-out activities for report to research manager.
• Liaises with PI, Sponsor, Research Manager and OCR Research Finance to support all study activities.
• Supports timely reporting of study status, enrollment, monitoring, and site visits.
• Coordinates scheduling of pre-site and site initiation visits with Research Manager and PIs.
• Performs quality control reviews and chart reviews; completes data collection and database queries.
• Engages in cross-coverage across OCR study support as needed.

Skills

Coordination

Clinical research

Regulatory knowledge

Cross-functional teamwork

Education

Bachelor's degree in Basic Science or related field

Job description

Senior Research Coordinator - Clinical Research Division: Office of Research Work Arrangement: Onsite only Location: Houston, TX Salary Range: $70,618 - $83,080 FLSA Status: Exempt Work Schedule: See Job Posting

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.

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.

Baylor College of Medicine fosters diversity among its students, trainees, faculty, and staff as a prerequisite to accomplishing our institutional mission and setting standards for excellence in training healthcare providers and biomedical scientists, promoting scientific innovation, and providing patient-centered care. Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.