CRA Heidelberg/Stuttgart

CR A Heidelberg/Stuttgart

Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into outcomes.

• Job Responsibilities
• Perform site qualification, site initiation, interim monitoring, site management activities, and close‑out visits (on‑site or remotely) ensuring regulatory, ICH‑GCP, Good Pharmacoepidemiology Practice, and protocol compliance.
• Verify informed consent processes for each subject/patient, protecting confidentiality and assessing factors affecting safety and data integrity.
• Assess site processes, conduct source document review, verify CRF data, resolve queries, and ensure compliance with electronic data capture requirements.
• Perform investigational product inventory, reconciliation, and reviews of storage and security.
• Review the Investigator Site File (ISF) for accuracy, timeliness, and completeness; reconcile with the Trial Master File (TMF).
• Document activities via confirmation letters, follow‑up letters, trip reports, communication logs, and other project documents; support recruitment, retention, and awareness strategies.
• Understand project scope, budgets, and timelines; manage site‑level activities to meet objectives, deliverables, and deadlines.
• Act as primary liaison with study site personnel and collaborate with Central Monitoring Associate; ensure training and compliance at assigned sites.
• Prepare for and attend investigator meetings, sponsor face‑to‑face meetings, and global clinical monitoring/project staff meetings.
• Provide guidance toward audit readiness and support audit preparation and follow‑up actions.
• Maintain knowledge of ICH/GCP guidelines, regulations, and company SOPs; 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 regulatory requirements.
• Previous monitoring experience in Germany.
• Proficient computer skills and ability to adopt new technologies.
• Fluency in German.
• Excellent communication, presentation, and interpersonal skills.
• Location in the Stuttgart/Heidelberg region.
• Ability to travel up to 75% of the time.

Benefits

• Career development and progression; supportive and engaged line management.
• Technical and therapeutic area training; peer recognition and total rewards program.
• Total Self culture promoting authentic self‑expression and inclusive workplace.
• Commitment to diversity, equity, and belonging across cultures and perspectives.

This posting is intended for an upcoming opportunity rather than a live role; interested candidates will be added to the talent pipeline for future consideration.

Any tasks, duties, or responsibilities not listed may be assigned at the Company’s discretion.

Equivalent experience, skills, and/or education will also be considered.

The Company’s sole discretion shall determine what constitutes equivalent qualifications.

All employment is subject to compliance with EU Equality Directive and the Americans with Disabilities Act, including reasonable accommodations when appropriate.

Roles within Clinical Monitoring/CRA involve overseeing and ensuring the integrity of clinical research studies by monitoring data and processes remotely, verifying regulatory compliance, and collaborating with site teams to implement quality enhancements.

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