Clinical Research Associate II

Ora

3d•Remote

About The Position

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.

Requirements

Bachelor’s degree with 2 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.
Demonstrated ability to verify source data to reported data.
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.
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 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 -- 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.

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 provided
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.