This is a proactive posting and not an active job opening
To support our future growth in Europe we are seeking experienced Clinical Research Associates with ophthalmology experience. We want welcome candidates who are passionate about advancing their careers in Clinical Research! We are looking for candidates for the following roles: Clinical Research Associates (I, II, Sr.) We’ll keep your information on file and will reach out when we have an upcoming opportunity!
POSITION TITLE: Clinical Research Associate
DEPARTMENT: Ora Europe
LOCATION: Remote, Europe

THE ROLE:

Ora’s Clinical Research Associate II (CRA II) develops strong clinical site relationships and is accountable for performance and compliance with assigned protocols at our sites. Our CRA II’s will work with the oversight of the Lead CRA’s and Line Manager. As a CRA II, you will ensure Ora’s compliance of study conduct by monitoring the site activities with ICH/GCP and country regulations, Ora’s policies, and Sponsor SOPs by partnering cross-functionally within Ora.

WHAT YOU’LL DO:

• Clear and sustained demonstration of the Ora Clinical’s Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor.
• 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 using various tools to ensure:
• Data generated at site are complete, accurate and unbiased.
• Subjects’ right, safety and well-being are protected.
• Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager.
• Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Supports audit/inspection activities as needed.
• Travel Requirements up to 75%.
• Adhere to all aspects of Ora’s quality system.
• Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements.Clear and sustained demonstration of Ora’s values
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• prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.

• Responsibilities may differ from the above based on the specific needs of the business.