Clinical Research Associate (CRA II/Sr) – Remote – Santiago
Syneos Health
Descripcion del puesto
About the role
Syneos Health is seeking an experienced Clinical Research Associate (CRA II or Senior CRA) to join its sponsor‑dedicated team. This remote position supports clinical sites in Santiago while ensuring compliance with regulatory and protocol requirements.
Key responsibilities
- Perform site qualification, initiation, interim monitoring, management activities and close‑out visits, either on‑site or remotely.
- Evaluate overall site performance, provide recommendations, and promptly communicate serious issues to the project team.
- Verify informed consent processes, protect patient confidentiality, and assess safety and data integrity risks.
- Conduct source document review, ensure accurate CRF data entry, and resolve queries within agreed timelines.
- Apply ICH/GCP guidelines, Good Pharmacoepidemiology Practice (GPP), and company SOPs throughout monitoring activities.
Required profile
- Minimum 3 years of experience in clinical monitoring.
- Strong knowledge of ICH/GCP guidelines and relevant regulatory requirements.
- Ability to assess site processes, identify deviations, and develop corrective action plans.
- Excellent communication skills for interacting with site staff and internal teams.
Required skills
- ICH/GCP compliance
- Good Pharmacoepidemiology Practice (GPP)
- Source document review
- Case Report Form (CRF) verification
- Query resolution techniques
- Pharmacovigilance awareness
What we offer
- Career development and progression opportunities.
- Supportive line management and peer recognition programs.
- Access to technical and therapeutic area training.
- Inclusive Total Self culture promoting authenticity and belonging.
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