Senior CRA – Sponsor Dedicated

🔥 0 minutes ago

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 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 and close-out visits • Evaluate site and site staff performance and provide recommendations and action plans • Communicate and 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 entered in case report forms against source documents and medical records • Apply query resolution techniques and drive resolution to closure • Use hardware and software for clinical study data review and capture • Verify site compliance with electronic data capture requirements • Perform investigational product inventory, reconciliation and storage/security reviews as needed • Verify investigational product dispensing and administration according to protocol • Review and reconcile Investigator Site Files with the Trial Master File • Document monitoring activities and enter observations, status and action items into tracking systems • Support subject/patient recruitment, retention and awareness strategies • Manage site-level activities and communication to meet project objectives, deliverables and timelines • Act as liaison with study site personnel and ensure assigned sites and project-specific staff are trained and compliant • Prepare for and attend Investigator Meetings, sponsor meetings, clinical monitoring meetings and training sessions • Support audit readiness and audit follow-up actions • Provide supervision, training and mentorship to junior CRAs as assigned • Participate in business development proposals and defense meetings 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 • Oncology experience • Good computer skills and ability to embrace new technologies • Fluency in German • Proficiency in speaking and writing English • Excellent communication, presentation and interpersonal skills • Moderate level of critical thinking skills • Ability to manage required travel of up to 75% on a regular basis • Ability to work from home in Germany • Ability to perform required site visits and clinical monitoring activities on-site or remotely

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive company culture • Reasonable accommodations for applicants and employees with disabilities

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