Clinical Research Associate

🔥 15 hours ago

🇩🇪 Germany – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

infoinfo

🗣️🇩🇪 German Required

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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, communicate serious issues, and develop action plans • Verify informed consent, subject confidentiality, safety, clinical data integrity, protocol deviations and pharmacovigilance issues • Assess site processes and conduct source document review and medical-record review • Verify clinical data in case report forms and resolve queries remotely and on site • Use hardware and software to support clinical study data review and capture • Verify electronic data capture compliance • Perform investigational product inventory, reconciliation, storage, dispensing and administration checks • Review Investigator Site Files and reconcile them with the Trial Master File • Document monitoring activities and enter observations 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 project site personnel and ensure assigned sites and team members are trained and compliant • Prepare for and attend investigator and sponsor meetings and clinical training sessions • Provide guidance on audit readiness and support audit preparation and follow-up • Mentor junior CRAs and perform training/sign-off visits as assigned • Potentially 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 in Germany • Good computer skills and ability to embrace new technologies • Excellent communication, presentation and interpersonal skills • Basic level of critical thinking skills • Fluency in English and German • 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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