Ground every answer in facts on this page and the original listing. We never invent Glassdoor-style reviews or salaries that are not in our data.
Be ready to walk through how you led CRAs or sites on complex, multi-country observational work: CAPAs, data queries, ethics/privacy boundaries, and how you balanced speed with quality. Prepare one example of cross-time-zone stakeholder management and one of fixing a monitoring quality gap.
Strong fit if you have CRA leadership experience in international observational or late-phase/real-world studies and can operate in a large enterprise (Oracle) setting in Cleveland. Weaker fit without multi-country monitoring leadership or observational-study familiarity.
As a Lead CRA for International Observational Studies at Oracle, a typical day centers on overseeing multi-country non-interventional research: site oversight, protocol and data-quality checks, vendor or site coordination, and escalating risks so observational endpoints stay inspection-ready.
Prioritize ICH-GCP, observational/RWE study design, multi-country site management, risk-based monitoring, and clear written reporting. No certification package was supplied for this listing; treat any credential path as optional unless the employer specifies one.
No. The listing marks remote as off and places the job in Cleveland, Cuyahoga County.
It points to senior clinical research associate work focused on leading monitoring quality for international observational (non-interventional) studies, not inventing a salary band or team size we do not have.
Oracle is a large public tech company (ORCL), founded 1977, with roughly 135,000 employees; see Wikipedia for the company overview used here.
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 Cleveland, Cuyahoga County Role Overview Join Oracle during this transformative period in Oncology and Rare Disease research. As a global leader, we are seeking a Senior Lead Clinical Research Associate (CRA) to drive success within our dynamic team. This role involves overseeing international observational studies, ensuring compliance with regulatory requirements, and collaborating closely with cross-functional teams. Day-to-Day Responsibilities Oversee the conduct of international observational studies, ensuring adherence to protocols and regulatory guidelines. Collaborate with local investigators, sponsors, and other stakeholders to ensure successful study execution. Perform site monitoring visits to assess compliance with clinical trial protocols and applicable regulations. Ensure data quality and integrity by conducting on-site audits and inspections. Prepare and review regulatory submissions and reports as required. Requirements Minimum of 10 years of experience in Clinical Research, with at least 5 years in a Lead CRA role. Proven track record in international observational studies within the field of Oncology or Rare Disease. Strong knowledge of regulatory requirements and guidelines (e.g., ICH, FDA, EMA). Excellent communication and interpersonal skills to effectively collaborate with cross-functional teams. Ability to travel internationally for site monitoring visits as needed. Working at Oracle At Oracle, you will be part of a global team driving innovation in the healthcare industry. We offer competitive compensation and benefits packages, along with opportunities for professional growth and development. Join us and make a difference in the lives of patients around the world. 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.
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