Senior Ophthalmic Clinical Research Associate

Ora; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Ora is seeking a Senior Clinical Research Associate to develop and maintain strong site relationships across ophthalmic trials. The Sr. CRA will monitor sites for compliance with ICH-GCP, Sponsor SOPs, local regulations, and study protocols, under the guidance of the Lead CRA and Line Manager.

You will gain deep understanding of study protocols, support site readiness, and collaborate with cross-functional teams to ensure data integrity and site performance throughout all trial phases.

Qualifications

• Ophthalmic CRA experience preferred.
• Bachelor's degree required with 3+ years in CRA role.
• Strong knowledge of ICH-GCP and regulatory requirements.

Responsibilities

• Develop strong site relationships and maintain continuity across all trial phases.
• Perform site monitoring in compliance with ICH-GCP, SOPs, and protocol.
• Understand study protocols and support site readiness.
• Coordinate with internal teams to manage site-related tasks.
• Provide input on site selection and validation activities.
• Assist with regulatory documentation and CTMS/eTMF recordkeeping.
• Travel up to 75% to monitor sites.

Skills

Ophthalmic experience

ICH-GCP compliance

Site qualification & selection

Data integrity & source data review

CTMS/eTMF knowledge

Travel up to 75%

Attention to detail

Cross-functional communication

Education

Bachelor's degree

Tools

CTMS

eTMF

Job description

Ora is seeking a Senior Clinical Research Associate to develop and maintain strong site relationships across ophthalmic trials. The Sr. CRA will monitor sites for compliance with ICH-GCP, Sponsor SOPs, local regulations, and study protocols, under the guidance of the Lead CRA and Line Manager.

You will gain deep understanding of study protocols, support site readiness, and collaborate with cross-functional teams to ensure data integrity and site performance throughout all trial phases.