THE ROLE:

Ora’s Lead Clinical Research Associate (Lead CRA) develops strong clinical site relationships and are accountable for hands-on delivery of project tasks in addition to delegation and oversight of more junior CRA’s project tasks, providing advice and guidance to help achieve high performance and quality project deliverables. Our Lead CRA’s will work independently and partner with the CRA line Manager to ensure Ora’s compliance with study conduct by monitoring the site activities regarding ICH/GCP and country regulations, Ora’s policies, and Standard Operating Procedures (SOPs) and sponsor requirements. The Lead CRA will work in collaboration with Ora’s Quality Assurance and Regulatory teams in addition to the external sponsors and sites through all phases of the trial.

WHAT YOU’LL DO:

• Independently customize and maintain the Monitoring Plan, Issues and Visit Report writing guidance, Project Specific Training material, Project Specific Training Logs.
• Ensure overall project efficiency and adherence to project timelines; report metrics and out-of-scope activities to the CRA line Manager, Sponsors, or Clinical PM’s.
• Collaborate with other functional groups within the company such as data management, project management, quality assurance and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles.
• Manage and follow study activities through ongoing tracking and review of study progress. Provide input and report progress to the assigned clinical project management leaders.
• Conduct review of CRA visit reports within required timeframe, track CRA compliance and proactively escalate quality or non-compliance issues to Monitoring Management.
• Handle escalations for site management questions and issues for assigned projects.
• Develop and deliver presentations & training to clients, colleagues and professionals, as required.
• May be assigned additional responsibilities as needed to support projects and other corporate/departmental initiatives.
• Host routine CRA team calls with a focus on best practice / knowledge sharing.
• Provide Central Data Review and coordinate Risk Based Monitoring strategy, as applicable.
• Supports audit and inspection activities as needed and may assist with on-site CRA training and evaluation upon request.
• Travel Requirements up to 25%.
• 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
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• 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.