Description
Syneos Health is seeking an Experienced CRA Germany - client dedicated. As a member of the Clinical Solutions team, you will act with a drug development mindset, applying your years of experience and deep expertise to truly understand customer needs and represent those in the solutions you shape.
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.
- 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.
- For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
- 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.
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.
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 required, in the full DACH region preferred.
- 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 for monitoring visits in Austria, Germany and Switzerland.
Benefits
Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition and total rewards program.