CRA II/Sr CRA – Ophthalmology

This is a fully remote position, open to applicants in Utah.

📋 Description

• Execute site qualification, initiation, interim monitoring, management, and close-out visits, either on-site or remotely.

• Assess the performance of sites and their staff, offering specific recommendations and action plans tailored to each site.

• Guarantee compliance with regulatory standards, ICH-GCP/GPP, and study protocols.

• Confirm that informed consent processes are followed, ensuring subject/patient safety and the integrity of clinical data.

• Conduct reviews of source documents and medical records.

• Validate clinical data entered into case report forms and address any queries.

• Ensure compliance with electronic data capture systems.

• Oversee the management of investigational product inventory, including reconciliation, storage, dispensing, and administration as necessary.

• Review and reconcile Investigator Site Files with Trial Master Files.

• Document monitoring activities through letters, trip reports, communication logs, and project documentation.

• Assist in strategies for subject/patient recruitment, retention, and awareness.

• Monitor observations, site status, and ensure action items are resolved.

• Manage site-level activities, including communications, deliverables, budgets, and timelines.

• Act as a liaison with study site personnel and Central Monitoring Associates.

• Provide training to assigned sites and project-specific site team members.

• Participate in investigator, sponsor, and global clinical monitoring meetings as well as clinical training sessions.

• Support audit readiness, preparation, and follow-up actions.

• For Real World Late Phase studies, assist sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local staff, train junior team members, identify out-of-scope activities, and recommend potential sites.

⛳️ Requirements

• Bachelor's degree or RN in a relevant field or an equivalent combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Proficient computer skills and a willingness to adopt new technologies.

• Exceptional communication, presentation, and interpersonal abilities.

• Capability to manage travel requirements of up to 75% on a regular basis.

• For employment in the US, adherence to site requests for medical and personal information necessary for facility access is required.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive total rewards program.

• Provision of a company car or car allowance.

• Medical, Dental, and Vision health benefits.

• Company-matched 401k plan.

• Eligibility to earn commissions or bonuses based on both company and individual performance.

• Flexible paid time off (PTO).

• Sick leave.