Ophthalmic Sr. Clinical Research Associate (Remote)

Ora; United States; Remote; USD 90,000 - 120,000; Full time

Benefits offered by this job

Healthcare options

401K with company match

Flexible PTO

Job summary

Ora is a leading ophthalmic drug and device development firm seeking a Senior Clinical Research Associate to manage site relationships and ensure compliant study conduct across all phases. This role reports to the Lead CRA and Line Manager and requires travel up to 75% within the United States.

You will monitor according to ICH-GCP and local regulations, support site qualification, and contribute to data integrity and regulatory documentation. Strong ophthalmic experience is preferred.

Qualifications

• Bachelor’s degree with 3 years’ experience as a Clinical Research Associate or equivalent.
• Ophthalmic experience is strongly preferred.
• Advanced knowledge of the federal regulations governing research and GCPs.

Responsibilities

• Develop strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gain in-depth understanding of the study protocol and related procedures.
• Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness.
• Participate & provide input on site selection and validation activities.
• Perform remote and on-site monitoring & oversight activities to ensure data integrity and subject safety.
• Communicate with Investigators and site staff on issues related to protocol conduct and documentation.
• Travel Requirements up to 75%.

Skills

Ophthalmic experience

Protocol compliance

Attention to detail

Multilingual communication

Education

Bachelor’s degree in related field

Tools

Excel

CTMS

EDC

Job description

Ora is a leading ophthalmic drug and device development firm seeking a Senior Clinical Research Associate to manage site relationships and ensure compliant study conduct across all phases. This role reports to the Lead CRA and Line Manager and requires travel up to 75% within the United States.

You will monitor according to ICH-GCP and local regulations, support site qualification, and contribute to data integrity and regulatory documentation. Strong ophthalmic experience is preferred.