CRA II Germany - multisponsor

Syneos Health; München; Hybrid; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

Syneos Health is looking for a Clinical Research Associate II (CRA II) based in Germany. In this role, you will conduct site qualification, initiation, and monitoring activities, ensuring compliance with regulatory standards.

The ideal candidate will have a Bachelor’s degree or RN, fluency in German and English, and two years of monitoring experience. You will be responsible for overseeing trial sites, maintaining communication, and adapting to project needs in the DACH region.

Qualifikationen

• Knowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirements.
• Two years of monitoring experience.
• Willingness to travel up to 75% of the time in the DACH region.

Aufgaben

• Perform site qualification, initiation, monitoring, and management activities.
• Evaluate site performance and develop action plans.
• Manage investigational product inventory and ensure compliance.

Kenntnisse

Fluency in German and English

Excellent communication, presentation and interpersonal skills

Good computer skills and openness to new technologies

Ausbildung

Bachelor’s degree or RN in a related field

Jobbeschreibung

CRA II Germany – multisponsor

Job Responsibilities

• Perform site qualification, site initiation, interim monitoring, site management activities and close‑out visits (on‑site or remotely) ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Evaluate overall site performance and provide recommendations regarding site‑specific actions; communicate or elevate serious issues and develop action plans.
• Verify that informed consent processes are properly performed and documented for each subject, protecting confidentiality and assessing factors that might affect safety and data integrity at investigator sites.
• Assess site processes, conduct source document review of site documents and medical records, verify accuracy of clinical data entered in the CRF, resolve queries, and ensure compliance with electronic data capture requirements.
• Manage investigational product inventory, reconcile and review storage and security, verify dispensation and administration according to protocol, and ensure appropriate labeling, import, release and return.
• Review and reconcile Investigator Site File contents with the Trial Master File, ensuring archival of essential documents per local guidelines.
• Document activities via letters, trip reports, communication logs and other required project documents per SOPs and monitoring plans. Support subject recruitment, retention, and awareness strategies and enter data into tracking systems.
• Understand project scope, budgets and timelines; manage site‑level activities and communications to meet project objectives and deadlines, adapting quickly to changing priorities.
• Act as primary liaison with study site personnel (or in collaboration with Central Monitoring Associate), ensuring all assigned sites and team members are trained and compliant with applicable requirements.
• Prepare for and attend investigator meetings, sponsor face‑to‑face meetings, global clinical monitoring/project staff meetings, and audit readiness activities.
• Maintain knowledge of ICH/GCP guidelines, relevant regulations and company SOPs/processes; complete required training.

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.
• Two years of monitoring experience.
• Good computer skills and openness to new technologies.
• Excellent communication, presentation and interpersonal skills.
• Fluency in German and English.
• Located in north‑east Germany; willing to travel up to 75% of the time in the DACH region.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks or duties at its discretion. Equivalent experience, skills, and/or education may also be considered.

All applicants are considered on the basis of their qualifications, experience and abilities, and not on race, color, religion, national origin, gender, sexual orientation, pregnancy, marital status, age, or disability. The Company is committed to compliance with the Americans with Disabilities Act and provides reasonable accommodations when appropriate.

Summary

Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes remote monitoring of trial sites, verifying regulatory and protocol compliance, using risk‑based monitoring techniques to identify potential issues, and collaborating with site teams to develop and implement tools and procedures that enhance quality and support overall clinical trial success.