CRA II, Sr CRA

🕒 October 21

🇨🇴 Colombia – 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, protocol, and company SOP/process compliance • Evaluate site and staff performance and recommend site-specific actions • Communicate and escalate serious issues and develop action plans • Verify informed consent processes, subject/patient confidentiality, safety, clinical data integrity, protocol deviations, and pharmacovigilance issues • Assess site processes and conduct source document review • Verify clinical data in case report forms and drive query resolution • Support clinical study data review, capture, and electronic data capture compliance • Manage investigational product inventory, reconciliation, storage, security, dispensing, and administration as applicable • 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 and communications to meet project objectives, deliverables, budgets, and timelines • Liaise with study site personnel and ensure site/project team training and compliance • Attend investigator, sponsor, global monitoring, project, and clinical training meetings • Support audit readiness, audit preparation, and follow-up actions • For real-world late-phase studies, provide site support throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local 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 • Knowledge of local requirements for real world late phase study designs • Must be a candidate from Barranquilla, Colombia

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Total Self culture supporting authenticity, diversity, and belonging

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