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Prepare to discuss CRA leadership on observational (non-interventional) studies: monitoring plans, data integrity, GCP-minded processes, and cross-border logistics. Ask how Oracle’s study portfolio, tools, and lead CRA span of control are defined for this team.
Strong fit if you lead clinical research associates on international observational work and can operate in a large enterprise tech environment (Oracle). Location is Thornton/Adams County, CO; confirm travel, hybrid expectations, and therapeutic/study scope in process.
As a Lead CRA for International Observational Studies at Oracle, a typical day centers on coordinating multi-country observational research quality and compliance rather than product engineering. Expect site and vendor oversight, protocol adherence checks, issue escalation, and status updates with clinical and study teams—while working from the Thornton area (onsite listing; remote flag off).
The listing marks remote as off and places the job in Thornton, Adams County, Colorado—confirm onsite or hybrid expectations with the recruiter.
Oracle is a major enterprise software and cloud company (ORCL), founded in 1977, with roughly 135,000 employees.
International observational study leadership: site quality, compliance, escalation, and clear communication with study stakeholders—not invented salary or review claims.
Website: oracle.com
Oracle Corporation is an American multinational technology company headquartered in Austin, Texas. Co-founded in Santa Clara, California, in 1977 by Bob Miner, Ed Oates, and current chairman of the board and chief technology officer Larry Ellison, Oracle is among the 20 largest companies in the world by market cap, and ranked 66th on the Forbes Global 2000 as of 2025.
Public cache only — not an employee review.
Lead CRA- International Observational Studies at Oracle in Thornton, Adams County What This Role Involves In this pivotal role, you will be a key member of our team driving success in international observational studies. With ongoing and ground-breaking developments in Oncology and Rare Disease, there has never been a more exciting time to join us! Your responsibilities will include ensuring the quality and integrity of clinical data, managing site relationships, and ensuring compliance with regulatory requirements. Responsibilities Ensure the quality and integrity of clinical data in international observational studies Manage site relationships and ensure smooth study execution Perform on-site monitoring visits to ensure adherence to protocols and regulatory requirements Prepare and submit all required documentation for regulatory bodies Collaborate with cross-functional teams to drive the success of international observational studies What We're Looking For Proven experience as a Lead Clinical Research Associate (CRA) or similar role in the pharmaceutical industry Demonstrated ability to manage multiple clinical trials simultaneously and meet deadlines Strong understanding of regulatory requirements, including GCP, ICH guidelines, and local regulations Excellent communication and interpersonal skills for building and maintaining relationships with site investigators and sponsors A minimum of 7 years of experience in the pharmaceutical or biotech industry, with a focus on international observational studies More About Oracle As a global leader in technology, Oracle is committed to driving innovation in healthcare. We are dedicated to providing our employees with an engaging and rewarding work environment that fosters personal growth and professional development. Applying for This Role To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there. We look forward to hearing from you!
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