CRA II – Multi-sponsor

🕒 February 4

🇲🇽 Mexico – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

Where this job comes from

Posted on Syneos Health's careers page, not through a job board

First seen by Remote Rocketship February 4

Logo of Syneos Health

Syneos Health

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 • Communicate and escalate serious issues to the project team and develop action plans • Verify informed consent processes, subject/patient confidentiality, safety and clinical data integrity • Conduct source document review and verify clinical data accuracy and completeness • Resolve queries remotely and on site and guide site staff toward closure within agreed timelines • Review investigational product inventory, reconciliation, storage, dispensing and administration compliance • Review Investigator Site Files and reconcile them with Trial Master Files • Document monitoring activities through confirmation letters, follow-up letters, trip reports and communication logs • 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 liaison with study site personnel and ensure assigned sites and project staff are trained and compliant • Attend Investigator Meetings, sponsor meetings, global clinical monitoring meetings and required training • Support audit readiness and preparation for audits and follow-up actions • For Real World Late Phase, support sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local staff, train junior staff, 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

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Total Self culture • Diversity, inclusion and belonging initiatives

Apply Now

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