Clinical Research Associate (CRA II / Sr) – Home‑Based in Colombia

About the role

Syneos Health is seeking an experienced Clinical Research Associate (CRA II or Senior) to support client‑focused studies across Colombia. This remote position involves overseeing site activities, ensuring compliance with regulatory standards, and safeguarding data integrity for clinical trials.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, management, and close‑out visits, either on‑site or remotely.
• Ensure adherence to ICH‑GCP, Good Pharmacoepidemiology Practice (GPP), and protocol requirements.
• Evaluate site performance, communicate serious issues promptly, and develop corrective action plans.
• Verify informed consent processes and protect patient confidentiality.
• Conduct source document reviews, confirm accurate CRF data entry, and resolve queries within agreed timelines.
• Assess safety, protocol deviations, and pharmacovigilance concerns at investigator sites.

Required profile

• Proven experience as a CRA II or Senior CRA in clinical trial monitoring.
• Strong knowledge of ICH‑GCP guidelines and relevant regulatory frameworks.
• Excellent analytical and problem‑solving abilities.
• Effective communication skills for remote collaboration with site staff.

Required skills

• ICH GCP compliance
• Good Pharmacoepidemiology Practice (GPP)
• Clinical site monitoring
• Source document review
• CRF data management and query resolution

What we offer

• Career development and progression within a global biopharmaceutical solutions organization.
• Supportive line management and total rewards program.
• Inclusive Total Self culture promoting authenticity and belonging.