Clinical Research Associate I - Real World Late Phase

Syneos Health; München; Vor Ort; EUR 45.000 - 65.000; Vollzeit

Zusammenfassung

Syneos Health is looking for a Clinical Research Associate (CRA) in Germany to ensure regulatory compliance during drug development. Responsibilities include site management activities, data integrity assessments, and close‑out visits.

The ideal candidate will hold a Bachelor’s degree or RN, possess excellent communication skills, and be fluent in German. This role may require travel up to 75% of the time across various locations in Germany.

Qualifikationen

• Knowledge of Good Clinical Practice / ICH Guidelines and other regulatory requirements.
• Experience in real‑world late phase studies is a plus.
• Ability to travel up to 75% of the time.

Aufgaben

• Perform site qualification, initiation, interim monitoring, and close‑out visits.
• Manage investigational product inventory, reconciliation, and ensure proper storage.
• Document all required activities per SOPs and support site lifecycle.

Kenntnisse

Excellent communication

Strong computer skills

Adaptability to new technologies

Fluency in German

Ausbildung

Bachelor’s degree or RN in a related field

Jobbeschreibung

Clinical Research Associate (CRA) - Germany

Syneos Health is a leading life sciences services organization dedicated to accelerating drug development.

We are looking for a Clinical Research Associate (CRA) based in Germany.

Job Responsibilities

• Perform site qualification, initiation, interim monitoring, site management activities, and close‑out visits (on site or remotely) ensuring regulatory compliance, ICH‑GCP, and Good Pharmacoepidemiological Practices.


• Verify informed consent processes, protect confidentiality, and assess safety and data integrity issues at investigator sites.


• Execute the Clinical Monitoring / Site Management Plan: conduct source document review, verify clinical data accuracy, resolve queries remotely and on site, and support electronic data capture compliance.


• Manage investigational product inventory, reconciliation, and ensure proper storage, labeling, dispensing, and associated risk mitigation.


• Review Investigator Site File accuracy, reconcile with Trial Master File, and ensure compliance with documentation retention regulations.


• Document all required activities (letters, trip reports, logs) per SOPs, support recruitment and retention strategies, and enter data into tracking systems.


• Understand project scope, budgets, and timelines; manage site‑level communications to meet objectives and deliverables, adapting to changing priorities.


• Act as primary liaison with site personnel, ensuring training and compliance with applicable requirements.


• Prepare for and attend investigator meetings, sponsor meetings, and clinical training sessions as needed.


• Provide guidance on audit readiness, support audit preparation, and follow‑up actions.


• For real‑world late phase studies, support site lifecycle from identification to close‑out, including chart abstraction and data collection.

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 regulatory requirements.


• Experience in real‑world late phase studies is a plus.


• Strong computer skills and adaptability to new technologies.


• Excellent communication, presentation, and interpersonal skills.


• Fluency in German.


• Preferred location: North, Mid, or West Germany.


• Ability to travel up to 75% of the time.

The Company is an equal opportunity employer and will consider qualified applicants regardless of race, color, religion, sex, national origin, age, disability, or veteran status.