CRA II

🕒 September 30

🇩🇪 Germany – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 15%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Perform site qualification, site initiation, interim monitoring, site management activities and close-out visits on-site or remotely • Evaluate site and site staff performance and provide recommendations regarding site-specific actions • Escalate serious issues to the project team and develop action plans • Verify informed consent processes and protect subject/patient confidentiality • Assess subject/patient safety, clinical data integrity, protocol deviations and pharmacovigilance issues • Conduct source document review and verify clinical data entered in case report forms • Resolve queries remotely and on site, and guide site staff toward resolution • Support clinical study data review and capture using available hardware and software • Manage investigational product inventory, reconciliation, storage, security and dispensing compliance • Review Investigator Site Files and reconcile them with the Trial Master File • Document monitoring activities through required letters, reports, communication logs and project documents • Support subject/patient recruitment, retention and awareness strategies • Track observations, ongoing status and action items to resolution • Manage site-level activities and communication to meet project objectives, deliverables and timelines • Act as primary liaison with study site personnel or collaborate with a Central Monitoring Associate • Ensure assigned sites and project-specific site team members are trained and compliant • Prepare for and attend Investigator Meetings, sponsor meetings, global clinical monitoring/project staff meetings and clinical training sessions • Support audit readiness and preparation for audits and follow-up actions • Complete assigned training and maintain knowledge of applicable guidelines, regulations and company SOPs

🎯 Requirements

• 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 applicable regulatory requirements • Previous monitoring experience in Germany • Good computer skills and ability to embrace new technologies • Fluency in both German and English • Excellent communication, presentation and interpersonal skills • Location in the southwest of Germany • Ability to manage required travel of up to 75% on a regular basis, with a strong focus on Switzerland

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations when appropriate

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