Senior Clinical Research Associate
vor 1 Monat
Job Title: Senior Clinical Research AssociateWe are seeking a highly skilled and experienced Senior Clinical Research Associate to join our team in Romania.
As a Senior CRA, you will be responsible for monitoring clinical trials in oncology and ensuring compliance with sponsor's procedural documents, international guidelines, and local regulations.
Key Responsibilities:Monitor multiple Phase II, III & IV clinical trial sites in oncology and assist other CRAs with co-monitoring activities.Support new CRA training and serve as a subject matter expert for clinical operations on monitoring-related activities.Implement and monitor clinical trials to ensure sponsor and investigator obligations are being met and compliant with applicable local regulatory requirements and ICH GCP guidelines.Assess the qualification of potential investigative sites, initiate clinical trials at investigative sites, instruct site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites.Review and verify accuracy of clinical trial data collected, either on site or remotely.Provide regular site status information to team members, trial management, and updates trial management tools.Complete monitoring activity documents as required by SOPs or other contractual obligations.Work closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.Assess investigational product (IP) accountability, dispensation, and compliance at the investigative sites.Verify SAE reporting according to trial specifications and ICH GCP guidelines.Communicate with investigative sites and update applicable tracking systems.Serve as main observer/assessor of site activities and facilitate audits and audit resolution.Requirements:4 or more years of clinical on-site monitoring experience required.Experience in monitoring all trial components (pre-study site visit [PSSV] to closeout visit [COV]) preferred.Experience in monitoring complex trials preferred.Oncology experience preferred.University degree in clinical, science, or health-related field from an accredited institution; a licensed healthcare professional (ie, registered nurse); or equivalent work experience required.Read, write, and speak fluent English; fluent in host country language required.Knowledge of ICH and local regulatory authority regulations regarding drug preferred.Experience in coaching/mentoring other CRAs preferred.What We Offer:We offer a competitive salary and a range of benefits, including various annual leave entitlements, health insurance, retirement planning, and a global Employee Assistance Programme.
We are committed to providing an inclusive and accessible environment for all candidates and employees.
At ICON, diversity, inclusion & belonging are fundamental to our culture and values.
We are proud of our diverse workforce and the work we've done to become a more inclusive organisation.
We're dedicated to providing an inclusive and accessible environment for all candidates and employees.
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