Clinical Research Associate I

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

📋 Description

• Establish and nurture strong relationships at the site, ensuring continuity throughout all phases of the trial.

• Conduct clinical study site management and monitoring activities under guidance, adhering to ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documentation.

• Attain a comprehensive understanding of the study protocol and related procedures.

• Collaborate with various internal roles to coordinate and manage tasks essential for achieving Site Readiness.

• Engage in and contribute to site selection and validation efforts.

• Execute both remote and on-site monitoring and oversight activities utilizing diverse tools to ensure:

• Data produced at the site is complete, accurate, and unbiased.

• The rights, safety, and well-being of subjects are safeguarded.

• Conduct site visits, which may include evaluation, initiation, monitoring, and close-out visits, ensuring that clear, comprehensive, and accurate visit and non-visit contact reports are recorded promptly.

• Gather, review, and oversee necessary regulatory documentation for study initiation, maintenance, and closure.

• Liaise with Investigators and site personnel regarding protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.

• Identify, evaluate, and address site performance, quality, or compliance issues, escalating them as necessary in collaboration with the Clinical Research Lead and CRA line manager.

• Manage and maintain information and documentation within CTMS, eTMF, and other systems as applicable and according to timelines.

• Assist with audit and inspection activities as required.

• Willingness to travel up to 75%.

• Comply with all aspects of Ora’s quality system.

• Follow all essential systems and processes required at Ora to uphold compliance with data integrity, business ethics, and regulatory standards.

• Consistently demonstrate Ora’s values—prioritizing kindness, operational excellence, fostering joy, and upholding scientific rigor—along with associated behaviors.

• Responsibilities may vary based on specific business needs.

⛳️ Requirements

• Bachelor’s degree with at least 1 year of experience in the clinical research field, or an equivalent combination of education, training, and experience. Experience may be considered in place of formal education.

• Preference for candidates with ophthalmic experience.

• Ability to routinely evaluate compliance with the protocol and GCP standards.

• Proven capability to verify the accuracy of source data against reported data.

• Strong attention to detail for reviewing the completeness of the investigator site file.

• Familiarity with federal regulations governing research and the standards that define Good Clinical Practices (GCPs).

• Proficient in reading and comprehending a clinical research protocol and recognizing the importance of adhering to it.

• Proficiency in Excel, CTMS, and EDC systems.

• Multilingual communication skills are advantageous.

🏝️ Benefits

• Competitive salaries accompanied by a structured pension plan.

• Access to private medical insurance starting on day one, provided by Vitality and SimplyHealth.

• Assurance through Canada Life to provide security for you and your family.

• 25 days of annual leave, plus Birthday PTO and bank holidays.

• Reimbursement to support your remote workspace and wellness purchases.

• Ongoing opportunities for professional growth and career development.

• Opportunities to collaborate with colleagues worldwide.

• A chance to research innovative ophthalmic therapies that will benefit patients globally.