Summary
This position in the Department of Ophthalmology leads the clinical research unit by overseeing staff and management of clinical research studies, ensuring compliance with study protocols, institutional policies, and GCP guidelines. This position requires candidates with attention to detail, good judgment, and ability to multitask and maintain organization for our robust clinical research portfolio. This position will supervise research coordinators and ophthalmic technicians.
This role requires a comprehensive understanding of clinical trial workflows, including regulatory submissions, budget development, subject recruitment, data management, and sponsor communications. The ideal candidate will have prior experience in ophthalmology or demonstrate the ability to quickly learn and support a wide range of ophthalmic assessments such as OCT, visual field testing, and fundus imaging. This position plays a critical role in maintaining research quality, operational efficiency, and patient safety.
Work schedule is flexible Monday - Friday between 7 am - 5 pm.
Job Duties
- Collaborates with Principal Investigators and clinical research staff to assess the feasibility of new study protocols, coordinates, and facilitates site qualification visits, and prepares and submits study budgets.
- Supervises the day-to-day operations of clinical trials, including patient recruitment, informed consent, data collection, and regulatory documentation
- Ensures compliance with IRB, FDA, and sponsor requirements, and maintains accurate and timely study records.
- Provides training, mentorship, and performance evaluations for research staff.
- Coordinates with sponsors, CROs, and institutional departments to facilitate study start-up, monitoring, and closeout activities.
- Assists in the development and implementation of standard operating procedures (SOPs) and quality assurance initiatives.
- Performs other job-related duties as assigned.
Minimum Qualifications
- High School diploma or GED.
- Four years of relevant experience.
Preferred Qualifications
- Bachelor's degree.
- Clinical research administration experience.
- Ophthalmology experience.
- Bilingual in Spanish is a plus.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.