Sponsor Dedicated CRA II/Sr CRA I/II

🕒 August 18

🇮🇹 Italy – Remote

💵 €45k - €69k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 29%

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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 on-site or remotely • Evaluate site and site staff performance and provide recommendations or site-specific action plans • 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 in case report forms against source documents and medical records • Resolve queries remotely and on site and guide site staff toward closure • Support clinical study data review and capture using hardware and software • Verify compliance with electronic data capture requirements • Manage investigational product inventory, reconciliation, storage, dispensing and administration when applicable • Review Investigator Site Files and reconcile them with Trial Master Files • Document monitoring activities through required letters, reports and communication logs • Support subject/patient recruitment, retention and awareness strategies • Track observations, site status and action items to resolution • Manage site-level activities and communication to meet project objectives, deliverables and timelines • Liaise with project site personnel and ensure assigned sites and team members are trained and compliant • Attend Investigator Meetings, sponsor meetings, clinical monitoring/project staff meetings and training sessions • Support audit readiness and preparation for audits and follow-up actions • Provide training or mentorship to junior CRAs and perform training/sign-off visits when assigned • Perform clinical operations lead tasks under supervision when assigned

🎯 Requirements

• At least 2,5 yrs of experience as Certified CRA according to DM 15 Nov 2011 • Oncology monitoring experience and phase I experience preferred • Experience with Risk Based Monitoring is 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 • Basic level of critical thinking skills • Ability to manage required travel of up to 75% on a regular basis • Equivalent experience, skills, and/or education may be considered

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Total Self culture • Diversity, inclusion and belonging initiatives • Additional benefits and allowances (not specified)

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