Senior Research Coordinator - Surgery

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 Surgery division to oversee complex clinical trials from start-up to closeout. You will manage day-to-day operations, regulatory submissions, participant screening and data collection, and ensure compliance with study protocols and policies.

The role includes mentoring junior coordinators, coordinating multi-site activities, and driving process improvements in recruitment, data quality, and study timelines.

Qualifications

• Bachelor's degree in a Basic Science or related field.
• Five years of relevant clinical research experience.
• Experience with regulatory submissions and trial oversight.

Responsibilities

• Oversee day-to-day clinical trial operations from start-up to closeout.
• Coordinate regulatory submissions, IRB documents, and monitoring.
• Provide oversight and mentorship to junior coordinators.
• Collaborate with PIs, sponsors, and regulatory teams.
• Develop timelines, workflows, and improve recruitment and data quality.

Skills

Regulatory knowledge

IRB submissions

Data management

Team mentorship

Study coordination

Education

Bachelor's degree in Basic Science

Tools

EPIC

RedCap

Medidata

Oracle

Job description

Job Title: Senior Research Coordinator - Surgery

Division: Surgery

Work Arrangement: Onsite only

Location: Houston, TX

Salary Range: $70,618 - $83,080

FLSA Status: Exempt

Work Schedule: Monday – Friday, 8 a.m. – 5 p.m.

Summary

The Senior Research Coordinator will oversee complex clinical research studies within the Cardiothoracic Division from study start-up through closeout. This role independently manages day-to-day clinical trial operations, including regulatory and IRB submissions, participant screening, recruitment, enrollment and monitoring, data collection and documentation, study progress, and enrollment milestones.

The position will work closely with Principal Investigators, sponsors, regulatory teams, research staff, and other stakeholders to ensure studies are conducted efficiently and in compliance with protocols, regulatory requirements, and institutional policies. The Senior Research Coordinator will also provideoversight, training, and mentorship to junior research coordinators, review their work, lead study and team meetings, and help resolve operational and regulatory issues.

Additional responsibilities include leading the planning and implementation of new research projects, developing timelines and workflows, coordinating projects involving multiple stakeholders, monitoring deliverables, addressing delays and resource constraints, and identifying opportunities to improve recruitment, data quality, participant experience, and overall study operations. The position will also contribute to strategic planning and recommendations for research program processes and resource allocation.

Schedule: Standard business hours, with occasional early mornings, evenings, or weekends depending on study protocol requirements.

Job Duties

15% Manage day-to-day clinical trial operations in the Division of Cardiothoracic Surgery, including oversight of junior research coordinators. Review junior staff work and provide feedback to improve accuracy, efficiency, and compliance. Lead team or study-specific meetings as appropriate. Lead planning and implementation of new research projects, including project plans, timelines, resource requirements, and workflows. Coordinate complex projects involving multiple stakeholders and deliverables.

20% Monitor project progress and proactively address delays, resource constraints, and competing priorities. Develop solutions to improve efficiency, recruitment, data quality, participant experience, and study execution. Participate in strategic planning and recommend process and resource improvements.

10% Maintain study records and regulatory documents. Serve as a resource for research processes, systems, and institutional procedures. Ensure activities comply with protocols, institutional policies, and applicable regulations. Identify compliance risks and escalate issues appropriately. Assist with or lead monitoring visits, audits, inspections, and internal quality reviews. Conduct quality-control reviews of study documentation and records.

10% Coordinate study activities across multiple sites, including BSLMC and Ben Taub Hospitals. Serve as a primary contact for investigators, research/clinical staff, sponsors, collaborators, and external partners. Communicate study status, risks, barriers, and recommendations to investigators and leadership. Independently coordinate multiple complex studies with competing timelines, larger teams, or multiple sites. Represent the research team in stakeholder meetings and proactively resolve operational issues.

30% Support screening, enrollment, sample collection, and monitoring of research participants for 5-10 studies. May collect blood or other samples. Serve as the operational lead for assigned studies from initiation through closeout. Proactively identify study issues and develop solutions with minimal supervision. Interpret protocols and translate requirements into operational processes. Conduct study activities as needed. Collect patient information, process documents, and enter data into databases. Collect, process, ship, and maintain documentation for biological specimens per protocol. Maintain study supplies. If handling investigational drugs/devices, follow sponsor protocols and Investigational Drug/Device Accountability policies. Coordinate participant payments following BCM and site policies. Schedule participants for protocol-required tests and procedures, including laboratory tests and X-rays. Attend surgical procedures. Collect protocol-required data, complete Case Report Forms, and enter data into EDC. Retrieve and submit test results. Ensure accurate data collection, documentation, organization, and participant safety. Assist the Principal Investigator with event reports, including Non-compliance, Adverse Events, and Unanticipated Problems. Design and administer questionnaires and surveys. Abstract medical record data and respond to study queries. Develop and maintain study timelines, milestones, and workflows.

5% Perform billing reconciliation in EPIC when research procedures are paid by the study.

5% Track Protocol Amendments, Clarification Letters, and study updates and implement changes accordingly.

5% Attend investigator meetings as required or requested by the PI and/or Sponsor. Perform other 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

• Medical Degree preferred.
• Certified Clinical Research Professional-CCRP, Certified Clinical Research Coordinator-CCRC from a clinical research organization (SoCRA or ACRP).
• Fluent in Spanish.
• Proficient in using spreadsheets, databases, and data management systems.
• Ability to understand and follow clinical research protocols and patient study requirements.
• Must be able to communicate effectively and in a professional manner, both orally and in writing, with internal and external collaborators.
• Experience with computer software and applications, including Microsoft Office and front-end database applications (RedCap, EPIC, Medidata, Oracle).
• Demonstrates problem-solving skills, takes action and meets deadlines assigned by Manager and/or PI.

Other

Working Conditions

• Work is performed primarily in an office environment but may require periodic visits to clinical and off-site clinical areas for purpose of interviewing patients.

Physical Demands

• Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.

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.