Contract Clinical Research Associate - Ophthalmology - Field-Based - 50-70% Travel

Clinical Research Associate (CRA) – Ophthalmology




Type: Contract

Location: Remote / Field-Based

Travel: Approximately 50–70%





Position Overview
Claris Bio is a late-stage biopharmaceutical company focused on developing transformative therapies for sight-threatening eye conditions with limited or no existing treatment options.

We are seeking a Clinical Research Associate (CRA) to support the execution of ophthalmology clinical trials. The CRA will independently monitor more than 10 clinical trial sites and help ensure that studies are conducted in accordance with study protocols, applicable regulatory requirements, and International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines.

This role is critical to protecting trial participants, maintaining data integrity, and supporting regulatory compliance throughout the clinical trial lifecycle. The CRA will work closely with investigative sites and cross-functional teams to promote high-quality, timely study execution.





The Contract Clinical Research Associate – Ophthalmology is a contract, remote/field-based role based in the central USA. We are open to candidates who are centrally located - ideally:






- Kansas City, Missouri/Kansas
- St. Louis, Missouri
- Omaha, Nebraska
- Oklahoma City or Tulsa, Oklahoma
- Dallas–Fort Worth, Texas
- Minneapolis–St. Paul, Minnesota
- Des Moines, Iowa
- Denver, Colorado
- Chicago, Illinois
- Nashville, Tennessee






Key Responsibilities

- Independently monitor multiple clinical trial sites to ensure compliance with study protocols, applicable regulatory requirements, sponsor procedures, and ICH-GCP guidelines.
- Conduct all types of site monitoring visits, including site qualification visits (SQVs), site initiation visits (SIVs), interim monitoring visits (IMVs), and close-out visits (COVs).
- Review ophthalmology-specific assessments, including visual acuity testing, ocular examinations, and ophthalmic imaging.
- Conduct on-site and remote monitoring visits to evaluate site performance, identify and resolve issues, and support high-quality study execution.
- Review informed consent documentation and verify compliance with participant-safety requirements.
- Verify that adverse events and serious adverse events (SAEs) are documented, escalated, and reported in accordance with protocol, regulatory, and sponsor requirements.
- Review clinical data and support accurate, complete, and timely data entry and query resolution in electronic data capture (EDC) systems.
- Collaborate with cross-functional teams, including Clinical Operations, Data Management, Medical Affairs, and other study functions, to support study timelines and deliverables.
- Serve as a primary point of contact for investigators, study coordinators, other site personnel, and contract research organization (CRO) partners.
- Prepare timely, accurate, and complete monitoring reports, follow-up correspondence, regulatory documentation, and site records.
- Train and guide site personnel on study protocols, procedures, systems, and compliance requirements.
- Develop and maintain productive working relationships with investigators, study coordinators, and other key stakeholders.
- Track findings and follow corrective and preventive actions through resolution.






Qualifications

- A bachelor’s degree in life sciences, nursing, clinical research, or another related healthcare or scientific discipline is strongly preferred. Relevant ophthalmic training, experience, or professional certification is considered an asset.
- At least three years of independent clinical site-monitoring experience as a Clinical Research Associate; five or more years is preferred.
- Experience monitoring ophthalmology clinical trials is strongly preferred.
- Strong knowledge of clinical trial processes, applicable regulatory requirements, and ICH-GCP guidelines.
- Familiarity with ophthalmic terminology, disease states, assessments, and research methodologies.
- Experience using clinical trial management systems (CTMSs), EDC systems, and ophthalmic imaging platforms or modalities.
- Demonstrated ability to manage more than 10 clinical trial sites and multiple priorities simultaneously.
- Strong organizational, analytical, and problem-solving skills.
- Excellent written and verbal communication skills, with the ability to collaborate effectively across functions.
- Ability and willingness to travel approximately 50–70% for site-monitoring activities. Air and ground travel are required.
- A valid driver’s license and the ability to meet applicable travel requirements are required.