CRA II / Snr CRA I – Multi Sponsor

🕒 3 days ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

Where this job comes from

Posted on Syneos Health's careers page, not through a job board

First seen by Remote Rocketship 3 days ago

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 activities 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 documentation • Assess subject/patient safety, clinical data integrity, protocol deviations and pharmacovigilance issues • Assess site processes for Clinical Monitoring/Site Management Plans • Conduct source document reviews and medical record reviews • Verify clinical data entered in case report forms is accurate and complete • Resolve queries remotely and on site within agreed timelines • Use hardware and software for clinical project data review and capture • 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 activities through letters, trip reports, communication logs and other project documents • Support subject/patient recruitment, retention and awareness strategies • Track observations, status and action items to resolution • Manage site-level activities and communications 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 • Attend Investigator Meetings, sponsor meetings, global monitoring meetings and clinical training sessions • Support audit readiness and audit preparation and follow-up actions • For Real World Late Phase: support sites throughout the study lifecycle, perform chart abstraction and data collection, and collaborate with sponsor affiliates, medical science liaisons and local country staff

🎯 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 • Good computer skills and ability to embrace new technologies • Excellent communication, presentation and interpersonal skills • 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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