Clinical Research Associate

vor 2 Wochen

Berlin, Deutschland Antal Sp. z o.o. Vollzeit

Clinical Research Associate (CRA) Location: Germany (Remote )   Job Description:We are seeking a highly motivated  Clinical Research Associate (CRA) to support multiple clinical studies. The Contractor will perform monitoring and site management activities while ensuring patient safety, regulatory compliance, and high-quality data in accordance with applicable SOPs, study protocols, and ISO 14155:2020. Key Responsibilities: Conduct monitoring activities including visit preparation, on-site visits, follow-up, site contact, and report writing. Perform remote monitoring and interim site management as required. Support site start-up activities including EC/CA submissions/amendments, contract negotiation, and documentation preparation/collection. Attend study meetings and collaborate with cross-functional teams and study sites throughout all study phases. Ensure monitoring of informed consents and site study files, including documentation for patients experiencing serious adverse events (SAEs). Report non-compliance of investigators with their Clinical Study Agreements (CSAs) to the Client. Finalize monitoring reports within 28 calendar days of each clinical site visit. Support audit preparation and responses. Perform additional services or projects only upon written approval from the Client. Qualifications / Requirements: Proven experience as a Clinical Research Associate (CRA) or equivalent role. Knowledge of GCP, ISO 14155:2020, and regulatory requirements. Strong organizational, communication, and report-writing skills. Ability to work independently and manage multiple studies/sites. Willingness to travel to clinical sites as required. Fluency in English; additional language skills (e.g. german) advantageous. Contract Details: B2B cooperation Services performed according to Client SOPs and study-specific Monitoring Plans. Why apply for an Antal job offer? When your application is successful, you will be supported by a dedicated Consultant who will stay in regular contact with you (via email or phone), help you prepare for interviews with your future employer, and ensure a smooth and professional recruitment process. About Antal Antal is a leading recruitment and HR advisory company, present in Poland since 1996 and later expanded to the Czech Republic and Hungary. Across the CEE region, we employ around 150 professionals who deliver a full range of services – from specialist and executive recruitment, employee outsourcing and HR consulting, to employer branding and market research. Our division-based structure combines deep industry expertise with functional specialisation, enabling us to provide tailored solutions for companies in every sector. We act as a trusted partner for both employers and candidates, sharing our knowledge and guiding them through every stage of the talent journey. We connect exceptional people with the right opportunities and help organisations build successful teams. Discover our latest job openings: https://en.antal.pl/candidatesFollow us on LinkedIn: https://www.linkedin.com/company/antalpoland      

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