Clinical Research Associate II – Sponsor-dedicated

🔥 1 minute ago

🇩🇰 Denmark – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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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 site-specific recommendations • Escalate serious issues and develop action plans • Verify informed consent processes and protect subject/patient confidentiality • Assess subject safety, clinical data integrity, protocol deviations/violations and pharmacovigilance issues • Conduct source document review and verify clinical data accuracy and completeness • Resolve queries remotely and on site within agreed timelines • 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 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 • Liaise with study site personnel and ensure assigned sites and project team members are trained and compliant • Attend investigator, sponsor, global monitoring and clinical training meetings • Support audit readiness, audit preparation and follow-up actions • For Real World Late Phase: support sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with Sponsor affiliates, medical science liaisons and local country staff, train junior staff when requested, identify out-of-scope activities, and suggest potential sites based on local knowledge

🎯 Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience • Oncology experience will be a plus • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements • Good computer skills and ability to embrace new technologies • Excellent communication, presentation and interpersonal skills • Ability to manage required travel of up to 65-75% 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, to assist employees or applicants to perform essential job functions

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