Senior Clinical Research Associate – FSP

🕒 October 16

🇷🇴 Romania – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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 • Ensure regulatory, ICH-GCP/GPP and protocol compliance • Evaluate site and site staff performance and provide site-specific recommendations and action plans • Verify informed consent processes, subject/patient confidentiality, safety and clinical data integrity • Assess site processes and conduct source document and medical record review • 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 study data review and capture; verify electronic data capture compliance • Perform investigational product inventory, reconciliation, storage, security and dispensing reviews • Review and reconcile Investigator Site Files with Trial Master Files • Document monitoring activities and maintain tracking systems • Support subject/patient recruitment, retention and awareness strategies • Manage site-level activities and communication to meet project objectives, deliverables and timelines • Liaise with study site personnel and ensure assigned sites and team members are trained and compliant • Attend investigator, sponsor, clinical monitoring and training meetings • Support audit readiness and audit follow-up actions • Supervise, train and mentor junior CRA staff as assigned • For RWLP, support sites throughout the study lifecycle, perform chart abstraction and data collection, develop informed consent forms, support regulatory activities, RFPs, budgeting, site management strategy and CRF design

🎯 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 • Moderate level of critical thinking 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 and total rewards program • Total Self culture supporting authenticity and employee wellbeing • Diversity, inclusion and belonging initiatives

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