Senior CRA – Sponsor-Dedicated, Cardiovascular Focus

IQVIA Inc; Ciudad de México; In loco; MXN 600.000 - 900.000; Tempo pieno

Descrizione del lavoro

IQVIA Inc is seeking an experienced Clinical Research Monitor in Mexico City to ensure sites conduct studies per protocol and regulatory guidelines. You will monitor sites, manage recruitment plans, train site staff, and maintain essential study documentation with regular communication to the study team.

The role requires 4+ years of on-site monitoring, travel flexibility, and strong English communication. Knowledge of GCP/ICH and regulatory standards is essential.

Competenze

• Bachelor's degree in a scientific or health-related field is preferred.
• Minimum 4 years of on-site monitoring experience with site visits and monitoring reports.
• Experience in clinical phase III and cardiovascular therapeutic area is desirable.
• Ability to travel and visit the office once per week.
• Solid knowledge of GCP, ICH guidelines and regulatory requirements.
• Proficiency with MS Word/Excel/PowerPoint and basic IT equipment.
• Strong written and spoken English communication, organizational and problem-solving skills.

Mansioni

• Perform monitoring visits (initiation, ongoing, close-out) per contract scope and GCP.
• Collaborate with sites to drive subject recruitment plans and predictability.
• Administer protocol training and establish regular site communication.
• Assess site practices for protocol adherence and regulatory compliance.
• Track regulatory submissions, recruitment, CRF completion, data queries, and resolutions.
• Maintain Trial Master File and Investigator Site File documentation.
• Generate visit reports, follow-up letters, and study documentation.
• Coordinate with study team for project execution and support startup activities.
• Support development of recruitment plans per site and assist site finance as needed.

Conoscenze

On-site monitoring

Clinical trial management

GCP/ICH knowledge

Regulatory requirements

Travel flexibility

English communication

MS Word

MS Excel

MS PowerPoint

Formazione

Bachelor's Degree in scientific discipline or healthcare

Strumenti

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Descrizione del lavoro

IQVIA Inc is seeking an experienced Clinical Research Monitor in Mexico City to ensure sites conduct studies per protocol and regulatory guidelines. You will monitor sites, manage recruitment plans, train site staff, and maintain essential study documentation with regular communication to the study team.

The role requires 4+ years of on-site monitoring, travel flexibility, and strong English communication. Knowledge of GCP/ICH and regulatory standards is essential.