Sr CRA II

Job Title:

Senior Clinical Research Associate II (Sr CRA II)

This Senior Clinical Research Associate II role focuses on performing and coordinating all aspects of clinical monitoring and site management across diverse studies and sponsors. You will conduct remote and on-site monitoring visits to assess protocol and regulatory compliance, manage essential documentation, and ensure that clinical trials are conducted in accordance with ICH-GCP guidelines, applicable regulations, and internal SOPs. Acting as a site process specialist, you will help safeguard participant rights and well-being, maintain data integrity, and support audit readiness while building strong, collaborative relationships with investigational sites.

• Perform and coordinate all aspects of clinical monitoring and site management for assigned studies, following applicable protocols, ICH-GCP guidelines, regulations, and SOPs.

• Conduct remote and on-site monitoring visits using a risk-based monitoring approach to assess protocol adherence, regulatory compliance, and data quality.

• Apply root cause analysis, critical thinking, and problem-solving skills to identify site process failures and implement corrective and preventive actions to bring sites into compliance and reduce risk.

• Ensure data accuracy and integrity through source data review (SDR), source data verification (SDV), and case report form (CRF) review during on-site and remote monitoring activities.

• Assess investigational product accountability through physical inventory checks and records review, ensuring proper storage, handling, and documentation.

• Document all monitoring observations clearly and accurately in reports and follow‑up letters using approved business writing standards and submit them in a timely manner.

• Escalate identified deficiencies, issues, and risks to clinical management promptly and track all issues through to full resolution.

• Maintain regular contact with investigative sites between monitoring visits, as needed, to confirm ongoing protocol compliance, timely data entry, and resolution of previously identified issues.

• Conduct monitoring tasks in accordance with the approved monitoring plan and study‑specific requirements.

• Participate in the investigator payment process by providing necessary site‑level information and supporting documentation.

• Share responsibility with other project team members for issue and finding resolution, collaborating closely to ensure consistent site oversight.

• Provide trial status tracking and progress updates to the Clinical Team Manager (CTM) and other stakeholders as required.

• Update study systems, such as the Clinical Trial Management System (CTMS), in line with agreed study conventions and perform quality control checks of CTMS‑generated reports when required.

• Participate in investigator meetings as needed, contributing to discussions on site performance, protocol requirements, and operational expectations.

• Identify potential investigators in collaboration with the sponsor to evaluate and recommend qualified investigative sites.

• Initiate clinical trial sites according to relevant procedures, ensuring compliance with the protocol, regulatory requirements, and ICH‑GCP obligations, and making recommendations where appropriate.

• Ensure proper trial close‑out, including retrieval of trial materials and verification that all study and regulatory requirements are met.

• Verify that all required essential documents are complete, accurate, and in place according to ICH‑GCP and applicable regulations.

• Conduct on‑site file reviews and perform regular checks of essential documents in line with project specifications.

• Contribute to the project team by assisting with the preparation of project publications,…