CRA I Germany

Job Overview Syneos Health® is a leading fully‑integrated life sciences services organization built to accelerate customer success. We partner with innovators across the drug development and commercialization continuum to navigate complexity and accelerate progress. For our team in Germany, we are hiring a CRA I to support clinical monitoring activities. Responsibilities Performs site qualification, site initiation, interim monitoring, site management activities and close‑out visits (on‑site or remotely) ensuring regulatory, ICH‑GCP or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. Assesses overall site performance, recommends site‑specific actions, escalates serious issues and helps develop action plans; maintains a working knowledge of ICH/GCP guidelines, regulations, and company SOPs. Verifies informed consent procedures, protects confidentiality, and assesses safety and data integrity risks such as protocol deviations or pharmacovigilance issues. Implements the Clinical Monitoring/Site Management Plan (CMP/SMP): conducts source document review, verifies CRF data, resolves queries, supports electronic data capture compliance, and uses hardware/software tools. Manages investigational product inventory, reconciles storage, ensures correct dispensing and handling of IP according to protocol and regulatory requirements. Reviews Investigator Site File (ISF) for accuracy and completeness, reconciles with Trial Master File (TMF), and ensures adherence to archiving requirements. Documents activities via letters, reports, and communication logs; supports recruitment, retention, and awareness strategies; enters data into tracking systems. Manages site‑level activities and communications to meet project objectives, budgets, and timelines; adapts quickly to changing priorities under lead CRA oversight. Acts as primary liaison with site personnel and collaborates with other CRA or Central Monitoring Associate (CMA); ensures training and compliance of all site staff. Prepares for investigator and sponsor meetings; participates in global monitoring/project staff meetings and attends training sessions as required. Provides guidance toward audit readiness and supports preparation and follow‑up actions for audits. 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 applicable regulatory requirements. Strong computer skills and the ability to embrace new technologies. Fluency in German and English. Excellent communication, presentation, and interpersonal skills. Preferably based in the northeastern part of Germany, able to travel across Germany and the DACH region. Equal Employment Opportunity Syneos Health is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, ethnicity, national origin, gender identity, sexual orientation, veteran status, or disability. If you have a disability that requires accommodation during the application process, please contact View email address on click.appcast.io for assistance. #J-18808-Ljbffr