Full-Time Clinical Research Associate II

Clinical Research Associate II Responsibilities:

As a Clinical Research Associate at PSI, you will monitor clinical studies across various therapeutic areas, adhering to industry-leading quality standards. You will:

• Serve as the primary point of contact between project teams, sponsors, and sites.
• Develop and maintain positive relationships with site staff involved in study conduct.
• Prepare, conduct, and report site selection, initiation, routine monitoring, and close-out visits.
• Ensure timely subject recruitment, communication, recording, and achievement of targets, alongside adherence to project timelines at the site level.
• Maintain accurate and timely communication with trial sites regarding Adverse Events and protocol/process deviations.
• Execute source data verification, address data queries, review, and manage study risks at the site level.
• Properly handle, use, account for, reconcile, and return Investigational Product(s) and clinical study supplies at sites.
• Review essential study documents and reconcile study Investigator Site File (ISF) / Trial Master File (TMF) at the site level.
• Maintain data integrity and compliance at the site level.
• Prepare for and conduct site audit preparation visits, resolving audit findings.
• Participate in study site audits and client on-site visits (as needed).
• Facilitate the flow of documents and study supplies between project teams, sites, and central/regional laboratories/reviewers/warehouses.
• Provide project-specific training to site investigators.
• Support the preparation of Investigator newsletters.
• Assist Site Management Associates in maintaining study-specific and corporate tracking systems at the site level.
• Support the preparation of regulatory and ethics committee submission packages.
• Collect IP-RED packages at the site/country level.
• Facilitate review and reconciliation of the study TMF at country and site levels.

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