Senior CRA I

🔥 1 minute ago

🇲🇽 Mexico – 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 • Ensure regulatory, ICH-GCP/GPP and protocol compliance • Evaluate site and site staff performance and recommend site-specific actions • Communicate and escalate serious issues and develop action plans • Verify informed consent processes, subject confidentiality, safety and clinical data integrity • Assess site processes and conduct source document review • Verify clinical data in case report forms and resolve queries • Review investigational product inventory, reconciliation, storage, security, dispensing and administration • Review Investigator Site Files and reconcile them 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, status and action items to resolution • Manage site-level activities, communications, objectives, deliverables and timelines • Liaise with study site personnel and ensure site teams are trained and compliant • Attend investigator, sponsor, monitoring, project and clinical training meetings • Support audit readiness, audit preparation and follow-up actions • Provide site support throughout the study lifecycle, including site identification through close-out • Perform chart abstraction and data collection • Collaborate with sponsor affiliates, medical science liaisons and local country staff • Train junior staff when requested • Identify and communicate out-of-scope activities • Suggest potential sites based on local treatment patterns, patient advocacy and healthcare provider associations

🎯 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 • Knowledge of local requirements for real world late phase study designs • Ability to perform chart abstraction activities and data collection • Ability to collaborate with Sponsor affiliates, medical science liaisons and local country staff

🏖️ 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

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