Senior Research Coordinator - Neurosurgery

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

Job summary

Baylor College of Medicine in Houston is seeking a Senior Research Coordinator for the Neurosurgery division. This full-time onsite role supports first-in-human pediatric epilepsy trials, coordinating administrative, regulatory, and operational tasks.

You will manage IRB and FDA submissions, assist with contract processes, and collaborate with investigators, research staff, and hospital finance to track trial budgets.

Qualifications

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

Responsibilities

• Coordinate IRB submissions, amendments, continuing reviews, and study closures.
• Assist with FDA submissions and regulatory documentation; maintain regulatory files.
• Support CTA processes and hospital budgeting for trial costs; track milestones.

Skills

Regulatory knowledge

Communication skills

Interpersonal skills

Cross-functional collaboration

Education

Bachelor's degree in Basic Science or related field

Job description

Senior Research Coordinator - Neurosurgery

Job Description Job Title: Senior Research Coordinator - Neurosurgery Division: Neurosurgery 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

We are seeking a qualified, experienced, professional who possesses advanced knowledge of clinical research practices for a full‑time position. This position will function in the clinical research section of the Department of Neurosurgery and Cain Foundation Laboratories. The personnel will function in a capacity in which they manage, coordinate, and facilitate first‑in‑human trial program to test various therapies for pediatric epilepsy and related disorders. The personnel will provide administrative, regulatory, and operational support for clinical and translational research studies. Responsibilities include managing scheduling and personnel activities, coordinating IRB and FDA submissions, assisting in clinical trial agreement processes, and Interfacing with hospital finance for trial costs. The ideal candidate is highly organized, detail‑oriented, and experienced in navigating regulatory requirements and cross‑functional collaboration within an academic medical center or clinical research environment.

Job Duties

40% Administrative Support

• Coordinate daily administrative activities for the research team, including managing calendars, scheduling meetings, and tracking project deadlines.
• Process purchases for research supplies and services, as well as travel requests and reimbursement paperwork.
• Assist with personnel-related activities, including onboarding, hiring documentation, and maintaining employee records.
• Prepare letters, reports, meeting materials, and other routine documents. Maintain organized research files and records.
• Serve as a point of contact for investigators, staff, and collaborators by responding to questions and coordinating communications.

40% Regulatory Support

• Prepare and submit IRB applications, amendments, continuing reviews, and study closures for human research studies.
• Coordinate required approvals with institutional and hospital offices before studies begin and throughout the life of the project.
• Assist with FDA submissions, including Investigational Device Exemption (IDE) applications, amendments, and annual renewals, when applicable.
• Maintain regulatory files and ensure study documentation is complete and up to date.

20% Contract and Financial Coordination

• Coordinate the clinical trial agreement (CTA) process by working with investigators, sponsors, and institutional contracting offices.
• Work with hospital finance and research administration to support clinical trial budgets, research billing, and study‑related financial processes.
• Track contract and regulatory milestones to help ensure studies are activated on schedule.

Scope and Impact

• Provides administrative, regulatory, and operational support.
• Helps ensure research projects remain organized, compliant with institutional and federal requirements, and progress efficiently from study startup through completion.
• Serve as point of contact for investigators, research staff, sponsors, and institutional partners regarding administrative and regulatory matters.
• Develop and improve workflows, standard operating procedures (SOPs), and tracking tools to increase the efficiency of research operations.
• Monitor study and regulatory deadlines to ensure timely completion of required submissions and approvals.
• Assist with preparing documentation for internal reviews, sponsor monitoring visits, and regulatory audits.
• Perform other duties and special projects as assigned to support departmental and institutional research objectives.

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

• Knowledge and experience of regulatory aspects of clinical research is a must.
• Effective communication skills, both orally and in writing.
• Ability to understand and implement research studies and protocols.
• Interpersonal skills necessary to coordinate research studies.

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: 26036

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.