CRA II / Senior CRA

🕒 September 28

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 16%

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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 and close-out visits on-site or remotely • Ensure regulatory, ICH-GCP/GPP and protocol compliance • Evaluate site and site staff performance and provide recommendations and action plans • Communicate or escalate serious issues to the project team • Verify informed consent, subject/patient confidentiality, safety and clinical data integrity • Assess site processes and conduct source document review • Verify clinical data accuracy and completeness in case report forms • Resolve queries remotely and on site and guide site staff • Support clinical study data review and capture using available hardware and software • Verify compliance with electronic data capture requirements • Perform investigational product inventory, reconciliation and storage/security reviews as needed • Review dispensing and administration of investigational product according to protocol • Review Investigator Site Files and reconcile them with Trial Master Files • Document monitoring activities through required project documents • Support subject/patient recruitment, retention and awareness strategies • Track observations, status and action items to resolution • Manage site-level activities and communication to meet project objectives, deliverables and timelines • Act as primary liaison with project site personnel or collaborate with a Central Monitoring Associate • Train assigned sites and project-specific site team members • Prepare for and attend Investigator Meetings, sponsor meetings and clinical training sessions • Participate in or lead clinical monitoring/project staff meetings under supervision • Support audit readiness, audit preparation and follow-up actions • Provide training or mentorship to junior CRAs • Perform training and sign-off visits for junior CRA staff as assigned • Perform clinical operations lead tasks under supervision as assigned

🎯 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 German and English • Excellent communication, presentation and interpersonal skills • Basic level of critical thinking skills • Ability to manage required travel of up to 75% on a regular basis • Location in the Frankfurt region preferred for assigned sites

🏖️ 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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