Ophthalmic Clinical Trial Associate I

Ora; United States; Remote; USD 50,000 - 70,000; Full time

Job summary

Ora Europe is seeking a Clinical Trial Associate I to support project managers and study teams across ophthalmic clinical trials. The role involves regulatory document collection, site budgeting, and document preparation to ensure study startup, maintenance, and closeout activities are compliant with GCP.

The CTA I will help maintain the Trial Master File, assist with CTMS, and support audits and regulatory submissions while traveling up to 10% as needed.

Qualifications

• Bachelor’s Degree with a minimum of 1 year of research experience.
• 1 year of clinical trial experience is strongly preferred.
• Ophthalmic experience and knowledge of GCP/ICH regulations are valuable.

Responsibilities

• Assist project managers and study teams in clinical study conduct.
• Support site regulatory document collection for accuracy and completion.
• Prepare essential document packages to support investigational product release.
• Create site regulatory bundles and assist with study startup and closeout activities.
• Maintain Trial Master File/eTMF and CTMS records.
• Help with audit preparations and regulatory submissions as needed.

Skills

Clinical trial experience

Ophthalmic experience

GCP/ICH knowledge

Regulatory documentation

Attention to detail

Education

Bachelor’s Degree

Job description

Ora Europe is seeking a Clinical Trial Associate I to support project managers and study teams across ophthalmic clinical trials. The role involves regulatory document collection, site budgeting, and document preparation to ensure study startup, maintenance, and closeout activities are compliant with GCP.

The CTA I will help maintain the Trial Master File, assist with CTMS, and support audits and regulatory submissions while traveling up to 10% as needed.