Clinical Research Associate II

Role Overview

• Acts as primary local company contact for assigned sites for specific trials.
• Develops meaningful site relationships through consistent collaborative communication and engagement.
• May participate in site feasibility and/or pre-trial site assessment visits
• Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies.
• Responsible for the implementation of risk based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
• Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
• Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe.
• Ensure site compliance with study protocol, ICH-GCP, and local/country regulations
• Ensure ongoing adequacy of site (facilities, staff) for trial conduct
• Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA
• Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas.
• Ensures site non-IMP study supplies are adequate for trial conduct.
• Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed.
• Oversees the appropriate destruction of clinical supplies.
• Ensures site staff complete data entry and resolve queries within expected timelines.
• Ensures validity and completeness of data collected at trial sites
• Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate.
• Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management.
• Fully documents trial related activities, in particular monitoring.
• Writes visit reports and follow-up letter in accordance with the SOPs.
• Promptly communicates relevant status information and issues to appropriate stakeholders.
• Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
• Aligns with relevant training requirements.
• Act as local expert in assigned protocols.
• Develops therapeutic knowledge sufficient to support role and responsibilities.
• Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits.
• Prepares trial sites for close out, conduct final close out visit.
• Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
• May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.

Requirements

• BA/BS degree with ≥3 years of experience in pharmaceutical related drug development or direct equivalent experience
• Three years site monitoring and/or site management experience
• Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines
• Strong critical thinking and problem solving skills
• Strong IT skills in appropriate software and company systems
• Willingness to travel up to 40% with overnight stay away from home (though the goal is to focus on remote monitoring)
• Proficient in speaking and writing English.
• Depending on hiring region, may also be required to be fluent in local language.
• Good written and oral communication.
• Oncology experience highly preferred
• Experience as an unblinded monitor required

Tech Stack

• Google Cloud Platform

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways