Clinical Research Associate II

📋 Description

• Cultivate and maintain strong relationships with sites, ensuring continuity throughout all stages of the trial.

• Execute clinical study site management and monitoring activities under supervision, ensuring compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and relevant documents.

• Acquire a thorough understanding of the study protocol and associated procedures.

• Coordinate and oversee various tasks in partnership with other internal roles to ensure Site Readiness.

• Contribute input during site selection and validation processes.

• Conduct both remote and on-site monitoring and oversight activities utilizing various tools to guarantee:

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

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

• Conduct site visits, including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits, and document clear, comprehensive, and accurate visit and non-visit contact reports in a timely manner.

• Collect, review, and oversee required regulatory documentation for study initiation, maintenance, and closure.

• Communicate with Investigators and site personnel regarding issues related to protocol execution, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.

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

• Manage and maintain records and documentation in CTMS, eTMF, and other relevant systems according to timelines.

• Assist with audit and inspection activities as required.

• Willingness to travel up to 75%.

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

• Consistently exemplify Ora’s values by prioritizing kindness, operational excellence, fostering joy, and scientific rigor, along with their associated behaviors.

⛳️ Requirements

• Bachelor’s degree with 2 years of experience as a Clinical Research Associate, or an equivalent combination of education, training, and experience. Relevant years of experience may substitute for formal education.

• Prior experience in ophthalmology is highly preferred.

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

• Proven capability to validate source data against reported data.

• Exceptional attention to detail for reviewing the completeness of the investigator site file, with knowledge of reconciling and managing test articles during initiation, interim, and close-out visits.

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

• Proficient in reading and comprehending clinical research protocols, understanding the importance of protocol adherence.

• Proficient in Excel, CTMS, and EDC systems.

• Multilingual communication skills are an advantage.

🏝️ Benefits

• Competitive salaries along with a structured pension scheme.

• Private medical insurance healthcare coverage starting from day one, provided by Vitality and SimplyHealth.

• Assurance through Canada Life to help you and your family feel secure.

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

• Reimbursement to support your remote workspace and wellness purchases.

• Ongoing opportunities for career growth and development.

• Opportunities to collaborate with colleagues worldwide.

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