Clinical Research Associate II

POSITION TITLE:

Clinical Research Associate II

DEPARTMENT:
Monitoring

Ora Values the Daily Practice of …

Prioritizing Kindness
* Operational Excellence
* Cultivating Joy
* Scientific Rigor

---

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.

• Responsibilities may differ slightly from the above based on specific needs of the business.
• 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.

• Experience needed for the Role:

  Bachelor’s degree with 2 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.
• 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…