Contract CRA- Ophthalmology | Southern, CA

Fidelis Companies; United States; On-site; USD 103,000 - 117,000; Full time

Job summary

Fidelis Companies seeks a Clinical Research Associate (CRA) for ophthalmology trials. This 6-month contract role is remote/field-based, with travel 50-70% and oversight of 10+ sites.

You will monitor sites for protocol compliance, perform SQVs/SIVs/IMVs/COVs, review ophthalmic assessments, manage data in EDC/CTMS, and collaborate across functions to ensure timely study delivery.

Qualifications

• Bachelor’s degree in life sciences or related field preferred.
• Ophthalmic training or certification is a plus.
• Minimum 5+ years independent CRA experience.
• Direct ophthalmology trial experience required.
• Strong knowledge of ICH-GCP and regulatory requirements.

Responsibilities

• Independently monitor 10+ sites to ensure protocol and regulatory compliance.
• Conduct SQVs, SIVs, IMVs, and COVs across ophthalmology trials.
• Review ophthalmology assessments and imaging, ensure data quality.
• Manage EDC data entry, query resolution, and CTMS usage.
• Collaborate with cross-functional teams to meet timelines.
• Train site staff on study protocols and regulatory requirements.
• Prepare monitoring reports and maintain site documentation.

Skills

Site monitoring

Ophthalmology

RCTs

Regulatory compliance

CTMS/EDC tooling

Education

Bachelor’s degree in life sciences

Ophthalmic training or certification

Tools

CTMS

EDC

Ophthalmic imaging platforms

Job description

Type: Contract CRA- Ophthalmology | Southern, CA

Duration: 6 months, with potential for extension

Location: Remote / Field-Based

Travel: Approximately: 50-70%

Pay Rate: $75-$85 hourly

Preferred Location: Candidates located in Southern California are highly preferred.

Position Overview

Our 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 and applicable regulatory requirements

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, clinical research, or another related healthcare or scientific discipline is strongly preferred. Relevant ophthalmic training, experience, or professional certification is considered an asset.
• 5+ years of independent clinical site-monitoring experience as a Clinical Research Associate.
• Direct ophthalmology clinical trial experience is required. Candidates must have worked on clinical studies involving ophthalmic indications, assessments, or endpoints.
• Strong, hands‑on experience supporting randomized controlled trials (RCTs) within a clinical research environment, including a solid understanding of study protocols, randomization, treatment arms, endpoints, and study procedures
• 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.
• Must have a valid driver’s license and the ability to meet applicable travel requirements are required.
• Candidates located in Southern California are highly preferred.