Clinical Research Associate II (Belgium)

Primarily a training and development role, this position will support and observe clinical site monitoring services both inhouse and in the field whilst developing CRA skills and knowledge.

Requirements

• Site management activities to help drive investigative site and patient recruitment, compliance, and oversight
• Conduct remote data review, support data query and closure activities, support Risk Based Monitoring (RBM) activities
• Assess data collection and (regulatory) document collection, perform remote and onsite activities for investigational sites
• Represent the corporation by maintaining collaborative relationships with stakeholders
• Support CRA II, Snr CRA and Lead CRA’s in day-to-day study management activities
• Remotely monitor, resolve and/or facilitate resolution of queries arising out of regular and/or safety reviews, adverse events, and other data management activities throughout the trial
• Coordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project life cycle
• Supports preparation for audit and required follow-up actions
• Identify and recruit site investigators, coordinate the movement and delivery of trial materials, samples, tests, and forms
• Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria
• Successfully complete CRA development track activities and milestones
• Develop and demonstrate competencies required to fulfill the role of a CRA
• Support and observe primary assigned CRAs at both onsite and remote visits
• Support Lead CRA’s with remote site management activities
• Participate on all study related activities, including but not limited to trainings, team meetings and provide any necessary updates to the study team