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