Research Analyst

• 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.

Clinical Research Associate II

• Join an innovative and dynamic environment supporting the Office of the Corporate Chief Underwriter (OCCU)
• Dive into a variety of exciting projects and research initiatives
• Support protective value (PV) studies; creating RFPs for different vendors and vendor evaluation
• Examine and identify new data sources for research and insights
• Improve workflows and work on ways to increase automation
• Provide input on predictive modeling
• Revise underwriting rules and procedures
• Partner with leadership across the enterprise to champion changes that improve processes, while maintaining mortality expectations
• Shape data sources for data driven underwriting practices
• Provide recommendations around new technologies and methodologies for risk selection
• Analyze, create, and develop rules for algorithmic and accelerated underwriting processes
• Develop new and competitive underwriting guidelines with research, documentation, marketing, and presentations

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Clinical Research Associate II

Life Underwriting Research Consultant