Senior CRA – FSP, Global Pharma

🕒 October 20

🇷🇴 Romania – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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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 and action plans • Ensure regulatory, ICH-GCP/GPP, protocol, and company SOP compliance • Verify informed consent processes, subject confidentiality, safety, clinical data integrity, and pharmacovigilance issues • Conduct source document review and verify clinical data accuracy and completeness • Resolve queries remotely and on site and guide site staff toward timely closure • Manage investigational product inventory, reconciliation, storage, dispensing, and return processes • Review and reconcile Investigator Site Files with Trial Master Files • Document monitoring activities through letters, trip reports, communication logs, and project documents • Support subject/patient recruitment, retention, and awareness strategies • Track observations, site status, and action items to resolution • Manage site-level activities and communications to meet project objectives, deliverables, budgets, and timelines • Liaise with project site personnel and train assigned sites and project-specific site team members • Attend investigator, sponsor, clinical monitoring, and training meetings • Support audit readiness and audit follow-up actions • Provide training and mentorship to junior CRAs and perform assigned training/sign-off visits • For RWLP, support sites throughout the study lifecycle, collaborate with sponsors and local teams, identify sites and efficiencies, develop country-level informed consent forms, and participate in bid defense meetings

🎯 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 • Basic level of critical thinking skills • Ability to manage required travel of up to 75% on a regular basis • Working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes • Ability to perform clinical monitoring activities on-site or remotely • For Real World Late Phase studies: knowledge of local requirements, chart abstraction, data collection, informed consent form development, and regulatory collaboration

🏖️ 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, to assist employees or applicants to perform essential functions

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