Senior CRA

🕒 October 20

🇨🇭 Switzerland – 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 20

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 and close-out visits on-site or remotely • Ensure regulatory, ICH-GCP/GPP and protocol compliance • Evaluate site and site staff performance and recommend site-specific actions • Communicate and escalate serious issues 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 accuracy and completeness • Resolve queries remotely and on site and guide site staff • Verify electronic data capture compliance • Manage investigational product inventory, reconciliation, storage, dispensing and administration as applicable • Review Investigator Site Files and reconcile them with Trial Master Files • Document monitoring activities and maintain tracking systems • Support subject/patient recruitment, retention and awareness strategies • Manage site-level activities and communications to meet project objectives, deliverables and timelines • Liaise with project site personnel and ensure assigned sites and team members are trained and compliant • Prepare for and attend investigator and sponsor meetings • Participate in or lead clinical monitoring/project staff meetings and attend clinical training • Support audit readiness and audit follow-up actions • Provide training or mentorship to junior CRAs • Perform training and sign-off visits for junior CRA staff as assigned • May perform clinical operations lead tasks under supervision

🎯 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 • Oncology knowledge • Good computer skills and ability to embrace new technologies • Excellent communication, presentation and interpersonal skills • Basic level of critical thinking skills • Fluency in German • Ability to manage required travel of up to 75% on a regular basis • Location in Eastern Switzerland is preferred

🏖️ 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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