Clinical Research Associate

Role Overview

• Assist in the clinical trial management to ensure timelines and metrics are met and maintained throughout the study
• Provides support in the oversight and management of vendors
• Conducts review of clinical data to ensure site adherence to applicable regulatory requirements, ICH Good Clinical Practice (GCP) Guidelines, company SOPs, and study protocol
• Supports with effective and timely audit/inspection responses
• Gains exposure/participates in case report form (CRF) development, IXRS set-up, central laboratory set-up, and other vendor selection processes and is capable of training others
• Oversees completion of Pre-Study Visits (PSVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs)
• Contributes to the resolution of escalated issues from study centers, regulatory authorities and institutional review board (IRBs) with the support of the supervisor, if needed
• Performs Sponsor Site Visits at selected sites to demonstrate oversight of the monitoring process and documenting the visits in the Sponsor Site Visit Report
• Oversees study centers to ensure timely execution of the clinical studies, generating quality data ensuring the well-being of the study subjects and the trial integrity with moderate supervision
• May assist on the TMF reviews and resolution of findings, internally or interacting with the CRO with support if needed
• Provides support on the regulatory document review and approval for investigational product (IP) release
• Provides support and information to the CTM staff regarding IP management, as needed
• May assist with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up
• May facilitate investigator site payments, as applicable
• Ability to facilitate meetings (e.g. Investigator Meetings, Kick-off meetings)
• May provide support for the monitor training and contribute to resolve the issues they identified
• Collaborates in ensuring that appropriate training is conducted for CRO staff, vendors, investigators, and study site staff on study requirements and internal SOPs
• Reviews and tracks comments of monitoring reports generated by the vendor as part of Sponsor Oversight of Vendor Clinical Site Monitoring activities
• Verifies study documents are tracked and reviewed for completeness and accuracy to ensure data integrity
• Tracks study specific tasks and progress of the trial
• Is involved in the oversight of vendor clinical monitoring activities
• Ensures that the clinical monitoring process is done in adherence to an international ethical and scientific quality standard to provide public assurance that the clinical data are credible
• Assists in the management of vendor performance during conduct of the study with moderate direct supervision

Requirements

• Typically requires 2 years of experience in clinical research, including a minimum of 1-year field monitoring experience (e.g., independent monitoring, co-monitoring, accompanied site visits)
• Associate’s degree in a life science field required
• Relevant experience in clinical research and field monitoring experience preferred (e.g. independent field monitoring and co-monitoring)
• 4 years clinical research experience with 2 years experience as a CRA
• Bachelor’s degree or higher degree in a life science field preferred.

Tech Stack

• Google Cloud Platform

Benefits

• Highly competitive salary
• Group pension scheme
• Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match
• Private Medical Insurance for the employee (Irish Life)
• Ongoing opportunities for career development in a rapidly expanding work environment
• Succession planning and internal promotions
• Education allowance
• Wellness activities
• Social activities eg. Padel, Summer Events