CRA II/Sr CRA I - Sponsor-Dedicated

🕒 September 7

🇸🇰 Slovakia – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 28%

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 • Evaluate site and site staff performance and provide recommendations regarding site-specific actions • Escalate serious issues to the project team and develop action plans • Verify informed consent processes, subject/patient confidentiality, safety and clinical data integrity • Assess site processes and conduct source document review • Verify clinical data entered in case report forms is accurate and complete • Resolve queries remotely and on site and guide site staff toward closure within agreed timelines • Use hardware and software for clinical study data review and capture • Verify compliance with electronic data capture requirements • Perform investigational product inventory, reconciliation and storage/security reviews as needed • Verify investigational product dispensing and administration according to protocol • Review Investigator Site Files and reconcile them with the Trial Master File • Ensure archiving of essential documents according to local guidelines and regulations • Document activities through confirmation letters, follow-up letters, trip reports, communication logs and other project documents • Support subject/patient recruitment, retention and awareness strategies • Track observations, ongoing status and action items to resolution • Manage site-level activities and communication to meet project objectives, deliverables and timelines • Act as primary liaison with study site personnel or collaborate with the Central Monitoring Associate • Ensure assigned sites and project-specific site team members are trained and compliant • Prepare for and attend Investigator Meetings and sponsor meetings • Participate in global clinical monitoring/project staff meetings and clinical training sessions • Provide guidance toward audit readiness and support audit preparation and follow-up • 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 • 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 ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes • Completion of assigned training as required

🏖️ 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, under the Americans with Disabilities Act

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