Site Start-Up CRA I/II - Hybrid (CDMX)

Syneos Health, Inc.; Ciudad de México; Hybrid; MXN 600,000 - 800,000; Full time

Job summary

Syneos Health is seeking a CRA I/II for Site Start-Up & Activation in Mexico City on a hybrid basis. You will perform site qualification, initiation, monitoring, and close-out visits, ensuring GCP compliance and regulatory adherence.

The role involves IP management, ISF review, and collaboration with sponsor teams. The position requires a Bachelor’s degree or RN, strong communication and computer skills, and willingness to travel up to 75% locally and abroad as needed.

Qualifications

• Bachelor’s degree or RN in a related field;
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Must demonstrate good computer skills and be able to embrace new technologies.
• Excellent communication, presentation and interpersonal skills.
• Ability to manage required travel of up to 75% on a regular basis.

Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remotely) ensuring regulatory and GCP compliance.
• Verifies informed consent and protects confidentiality; assesses safety and data integrity at investigator sites.
• Assesses CMP/SMP, reviews source documents and CRF data, resolves queries remotely and on site.
• May perform IP inventory, reconciliation and storage; ensure IP labeling, import and release per protocol.
• Routinely reviews the ISF for accuracy and archiving; reconciles with TMF.
• Documents activities, supports recruitment and data tracking; enters data into tracking systems.
• Manages site-level activities, timelines and budgets with oversight of Lead CRA; adapts to priorities.
• Acts as liaison with site personnel; ensures training and compliance.
• Prepares for Investigator Meetings and sponsor meetings; participates in training.
• Supports audit readiness and post-audit follow-up.
• For Real World Late Phase, Site Management Associate I: lifecycle site support, chart abstraction, collaboration with affiliates.

Skills

GCP knowledge

Communication skills

Computer skills

Travel up to 75%

Education

Bachelor’s degree or RN

Job description

Syneos Health is seeking a CRA I/II for Site Start-Up & Activation in Mexico City on a hybrid basis. You will perform site qualification, initiation, monitoring, and close-out visits, ensuring GCP compliance and regulatory adherence.

The role involves IP management, ISF review, and collaboration with sponsor teams. The position requires a Bachelor’s degree or RN, strong communication and computer skills, and willingness to travel up to 75% locally and abroad as needed.