Clinical Research Associate

About This Role

This Senior Clinical Research Associate (Level I) role offers the opportunity to make an impact at the forefront of innovation by performing and coordinating all aspects of clinical monitoring and site management. You will conduct remote and/or on-site visits to assess protocol and regulatory compliance, managing required documentation and ensuring trials adhere to approved protocols and guidelines to guarantee subjects' rights, well-being, and data reliability.

Responsibilities

• Monitor investigator sites with a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving skills to identify site process failures and corrective/preventive actions
• Ensure data accuracy through SDR, SDV, and CRF review as applicable through on-site and remote monitoring activities
• Assess investigational product through physical inventory and records review
• Document observations in reports and letters in a timely manner using approved business writing standards
• Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution
• Maintain regular contact between monitoring visits with investigative sites to confirm protocol adherence, issue resolution, and timely data recording
• Conduct monitoring tasks in accordance with the approved monitoring plan
• Participate in the investigator payment process
• Ensure shared responsibility with other project team members on issues/findings resolution
• Investigate and follow-up on findings as applicable
• Provide trial status tracking and progress update reports to the Clinical Lead (CL) as required
• Ensure study systems are updated per agreed study conventions (e.g., Clinical Trial Management System, CTMS)
• Perform QC check of reports generated from CTMS system where required
• Participate in investigator meetings as necessary
• Identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites
• Initiate clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted
• Ensure trial close out and retrieval of trial materials
• Ensure that required essential documents are complete and in place, according to ICH-GCP and applicable regulations
• Conduct on-site file reviews as per project specifications
• Contribute to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members
• Perform additional study tasks as assigned by the CL (e.g., trip report review, newsletter creation, lead CRA team calls etc.)