Clinical Research Associate / Germany @ Antal
(práce v Německu)

Clinical Research Associate / Germany @ Antal

Německo

• 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.

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.

Contract Details:

• B2B cooperation
• Services performed according to Client SOPs and study-specific Monitoring Plans.

,[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.] Requirements: GCP, ISO 14155:2020, Regulatory requirements

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