Job Description :
The responsibility of a Clinical Research Associate (CRA) is to perform the clinical monitoring aspect of designated projects in accordance with applicable SOP and regulations. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection), collecting regulatory documentation (when required), performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines. ' Assume the ability to meet the requirements of a CRA I with a high degree of proficiency and autonomy ' Take responsibility for specific tasks on projects, or acts as the main CRA contact on individual projects ' Train team members on selected tasks ' Keep manager informed about work progress and any issues to avoid surprises. Requires some interaction / supervision by Manager or assigned mentor. ' Build relationships with investigators and site staff ' Participate in Investigator and other external or internal meetings as required ' Arrange on-site visits and logistics (e.g. travel arrangements) ' Perform on site visits in accordance with the monitoring plan ' Conduct on-site study-specific training (if applicable) ' Perform site facilities inspection ' Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations ' Monitor and maintain ICH-GCP compliance ' Responsible for the completeness and quality of the on-site files ' Respond to site issue alerted from Clinical Monitoring Associate (i.e, non-responsive site, Protocol Deviations concerns, quality issues etc., items that require face to face interaction) ' Collect SRP documents during QV and other visits as needed ' Establish site recruitment plan in collaboration with site during Qualification Visit; follow-up and update at Initiation Visit and Monitoring Visit ' Update all relevant tracking system on an ongoing basis ' Collaborate with CMA on site issues/actions ' Generate visit/contact report in accordance with monitoring plan ' Code and scan Central File documents where applicable ' Ship relevant wet-ink signature documents to the Assistant or back to the site ' Escalate any issues that require immediate action to the CRA Coordinator/GRO Lead ' Attend audits / Regulatory Inspection if requested
Education ' Educated to degree level (biological science, pharmacy or other health-related discipline preferred), equivalent nursing qualification or other equivalent experience Language Skills ' Competent in written and oral English Minimum Work Experience ' Substantial monitoring experience in clinical research Skills: Ability to communicate with professional medical personnel. Understanding of the drug development process. Ability to complete tasks in an accurate and timely manner. Physical Requirements: Ability to travel an average of 60-65%.