CRA risk-based monitoring

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. As a CRA, you'll collaborate with sites, data-driven insights, and focus on activities that truly impact study quality, patient safety, and success of the trial. You'll make a difference in clinical research while growing your career! Job Responsibilities Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site. Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes, conducts Source Document Review, verifies required clinical data entered in the case report form (CRF) is accurate and complete. May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. Qualifications: Bachelor's degree or RN in a related field or equivalent combination of education, training and experience Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Previous monitoring experience in Germany, preferably in oncology Experience in risk-based monitoring is a plus Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, presentation and interpersonal skills Fluency in German and English Ability to manage required travel of up to 75% on a regular basis for monitoring visits Job Data by YubHub .