Senior Clinical Research Associate

Ora

1d • Hybrid

About The Position

Ora is seeking a Senior Clinical Research Associate (Sr. CRA) to join our Monitoring department. In this role, you will be responsible for developing strong clinical site relationships and ensuring compliance with assigned protocols. You will work under the oversight of the Lead CRA and Line Manager, ensuring adherence to ICH/GCP, country regulations, Ora’s policies, and Sponsor SOPs. This position involves partnering with Quality Assurance and Regulatory teams, and building relationships with sponsors and sites throughout all trial phases. A deep understanding of study protocols and participation in site selection and validation activities are crucial. After training, Sr. CRAs will act as the primary site contact and manager for allocated sites throughout clinical research studies.

Requirements

• Bachelor’s degree with 3 years’ experience as a Clinical Research Associate or equivalent combination of education, training, and experience.
• Ophthalmic experience is strongly preferred.
• Capacity to routinely assess protocol and GCP compliance.
• Ability 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.

Nice To Haves

• Multilingual communication is a plus.

Responsibilities

• Develop strong site relationships and ensure continuity through all phases of the trial.
• Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents, with oversight.
• Gain in-depth understanding of the study protocol and related procedures.
• Coordinate and manage various tasks in collaboration with other internal roles to achieve Site Readiness.
• Participate and provide input on site selection and validation activities.
• Perform remote and on-site monitoring and oversight activities using various tools to ensure data accuracy, subject safety, and well-being.
• Conduct site visits (evaluation, initiation, monitoring, close-out) and record clear, comprehensive, and accurate visit and non-visit contact reports in a timely manner.
• Collect, review, and monitor required regulatory documentation for study start-up, maintenance, and 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.
• Adhere to all aspects of Ora’s quality system.
• Adhere to all essential systems and processes required at Ora to maintain compliance with Ora’s data integrity, business ethics, and regulatory requirements.
• Demonstrate Ora’s values: prioritizing kindness, operational excellence, cultivating joy, and scientific rigor, along with their linked behaviors.

Benefits

• Comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
• Flexible PTO & Unlimited Sick Time.
• 14 company paid holidays.
• Competitive salaries.
• 401K plan through Fidelity with company match.
• Adoption and fertility assistance.
• 16 weeks paid Parental Leave.
• Company Paid Life & Disability Insurance.
• Remote & Wellness Reimbursement.
• Employee Assistance Program.
• Continued opportunities to grow and develop your career journey.
• Opportunities to work with colleagues across the globe.
• A chance to research new ophthalmic therapies that will impact patients across the globe.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior