CRA Risk-Based Monitoring

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🔥 1 minute ago

🇩🇪 Germany – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🎲 Risk

👻 Ghost score 10%

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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 recommend site-specific actions • Communicate and escalate serious issues to the project team and develop action plans • Verify informed consent processes, subject/patient confidentiality, safety, clinical data integrity, protocol compliance and pharmacovigilance issues • Assess site processes and conduct Source Document Review of site source documents and medical records • Verify clinical data entered in case report forms and electronic data capture compliance • Resolve queries remotely and on site within agreed timelines • Perform investigational product inventory, reconciliation, storage, dispensing and administration reviews • Review Investigator Site Files and reconcile them with the Trial Master File • Document monitoring activities through letters, trip reports, communication logs and project documents • Support subject/patient recruitment, retention and awareness strategies • Track observations, site status and action items to resolution • Manage site-level activities and communications to meet project objectives, deliverables and timelines • Act as liaison with study site personnel and ensure assigned sites and team members are trained and compliant • Attend investigator, sponsor, clinical monitoring and training meetings • Support audit readiness and audit follow-up actions • Complete assigned training and maintain knowledge of applicable guidelines, regulations and company procedures

🎯 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, preferably in oncology • Experience in risk-based monitoring is a plus • Good computer skills and ability to embrace new technologies • Excellent communication, presentation and interpersonal skills • Fluency in German and English • Ability to manage required travel of up to 75% on a regular basis for monitoring visits

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Total Self culture • Diversity, inclusion and belonging initiatives

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