CRA II/Sr CRA – Moldova, Macedonia

🔥 5 hours ago

🌐 Moldova, North Macedonia – Remote

🇲🇩 Moldova – Remote 🇲🇰 North Macedonia – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 activities and close-out visits on-site or remotely • Ensure regulatory, ICH-GCP/GPP and protocol compliance • Evaluate site and site staff performance, provide recommendations, escalate serious issues and develop action plans • Verify informed consent, subject/patient safety and clinical data integrity • Assess site processes and conduct source document review and medical record review • Verify clinical data in case report forms and support query resolution remotely and on site • Use hardware and software for clinical study data review and capture; verify electronic data capture compliance • Perform investigational product inventory, reconciliation, storage, dispensing and administration reviews as applicable • Review Investigator Site Files and reconcile them with the Trial Master File • Document monitoring activities through letters, trip reports, communication logs and other project documents • Support subject/patient recruitment, retention and awareness strategies • Track observations, site status and action items through resolution • Manage site-level activities and communications to meet project scope, deliverables, objectives and timelines • Liaise with study site personnel and Central Monitoring Associates • Ensure assigned sites and project-specific site team members are trained and compliant • Attend investigator meetings, sponsor meetings, global project meetings and clinical training sessions • Support audit readiness, audit preparation and follow-up actions • For Real World Late Phase: provide site support from identification through close-out, conduct 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

🎯 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 • Working knowledge of relevant regulations and company SOPs/processes • Ability to work with clinical monitoring, site management, source document review, case report forms, electronic data capture and trial documentation • For Real World Late Phase: knowledge of local requirements for real world late phase study designs • 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 • Total rewards program • Total Self culture supporting authenticity and inclusion • Diversity, equity and belonging initiatives

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