Senior Clinical Research Associate

What You’ll Do

• Develop strong site relationships and ensure continuity of site relationships through all phases of the trial.
• Perform, 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, and subjects’ rights, safety and well-being are protected.
• Conduct site visits including evaluation visits, initiation visits, monitoring visits, close-out visits and record clear, comprehensive and accurate visit & non-visit contact reports 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 escalate 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.
• Support 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 required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements.
• Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.

What We Look For

Experience needed for the Role: Bachelor’s degree with 3 years’ experience as a Clinical Research Associate or equivalent combination of education, training and experience. Years of experience may be considered in lieu of education.

Additional Skills & Attributes

• Ophthalmic experience is strongly preferred.
• Capacity to routinely assess protocol and GCP compliance.
• Ability to understand how to properly assess an investigative site’s capabilities to conduct clinical research.
• Demonstrated ability to verify source data to reported data.
• Ability to monitor and report on the progress of the trial from start-up to completion.
• Knowledge of how to select and qualify an investigative site.
• Strong attention to detail to review the completeness of the investigator site file.
• Knowledge to reconcile and return/destroy test articles while conducting initiation, interim, and close-out visits.
• Advanced knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).
• Ability to read and demonstrate comprehension of a clinical research protocol as well as understand the importance of following the protocol.
• Proficiency with Excel, CTMS, and EDC.
• Multilingual communication is a plus.

Competencies and Personal Traits

• Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
• IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy.
• Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again.
• Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in communication and participate in active giving and receiving feedback frequently, with an open heart and mind to create psychological safety and promote faster individual, team and company growth.
• Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world.