Senior CRA – Multisponsor

🕒 October 19

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🗣️🇩🇪 German Required

Where this job comes from

Posted on Syneos Health's careers page, not through a job board

First seen by Remote Rocketship October 19

Logo of Syneos Health

Syneos Health

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 • Ensure regulatory, ICH-GCP/GPP and protocol compliance • Evaluate site and site staff performance and provide recommendations and action plans • Verify informed consent processes and documentation • Assess subject/patient safety, clinical data integrity, protocol deviations and pharmacovigilance issues • Conduct source document review and verify clinical data accuracy and completeness • Apply query resolution techniques remotely and on site • Verify electronic data capture compliance • Perform investigational product inventory, reconciliation and storage/security reviews • Verify investigational product dispensing and administration according to protocol • Review Investigator Site Files and reconcile them with Trial Master Files • Document monitoring activities and enter data into tracking systems • Support subject/patient recruitment, retention and awareness strategies • Manage site-level activities and communications 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 and sponsor face-to-face meetings • Participate in global clinical monitoring/project staff meetings and clinical training • Support audit readiness, audit preparation and follow-up actions • Complete assigned training as required

🎯 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 • Several years of monitoring experience • Good computer skills and ability to embrace new technologies • Excellent communication, presentation and interpersonal skills • Fluency in German and English • Location in north Germany • Ability to manage required travel of up to 75% on a regular basis

🏖️ 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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