Sr CRA in oncology - Sponsor dedicated - Home Based Germany

Overview

Sr CRA in oncology – Sponsor dedicated – Home Based Germany

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer and the patient, aiming to simplify and streamline work and to accelerate the delivery of therapies.

Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE.

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (on-site or remote) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance. Evaluates overall site performance and staff, provides recommendations, and escalates serious issues with action plans. Maintains knowledge of ICH/GCP, applicable regulations, and SOPs/processes.
• Verifies informed consent process and documentation for each subject as required. Protects confidentiality and assesses factors affecting subject safety and data integrity (protocol deviations, pharmacovigilance issues).
• Assesses site processes per CMP/SMP; conducts Source Document Review, verifies CRF data accuracy and completeness through source documents. Applies remote and on-site query resolution, guides site staff, drives closure within timelines. Utilizes hardware/software to support data review and capture; ensures site compliance with electronic data capture requirements.
• Manages investigational product (IP) inventory, reconciliation, storage and security. Verifies IP dispensing and administration per protocol; handles IP labeling, import, release/return in line with GCP/local regulations.
• Routinely reviews the Investigator Site File (ISF) for accuracy and completeness; reconciles with the Trial Master File (TMF). Ensures archiving of essential documents per local guidelines and regulations.
• Documents activities via letters, reports and logs; supports subject recruitment and retention; enters data into tracking systems to monitor observations and actions to resolution.
• Understands project scope, budgets, and timelines; manages site-level activities/communication to meet objectives and adapt to changing priorities.
• May act as primary liaison with study site personnel or with Central Monitoring; ensures sites and team members are trained and compliant with requirements.
• Prepares for and attends Investigator Meetings and sponsor meetings; participates in or leads global clinical monitoring/project staff meetings as required; attends clinical training sessions per project requirements.
• Provides guidance toward audit readiness and supports audit preparation and follow-up actions.
• May provide direct supervision, training and mentorship to junior CRAs; may participate in business development proposals and defense meetings as assigned.

• 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
• Oncology experience preferred
• Strong computer skills and adaptability to new technologies
• Fluency in German
• Excellent communication, presentation and interpersonal skills; good critical thinking
• Ability to travel up to 75% regularly

Tasks, duties, and responsibilities as listed are not exhaustive. The Company may assign additional tasks at its discretion. Equal opportunity employer statements and ADA compliance information are included as applicable to the jurisdiction of employment.