Senior CRA: Site Monitoring & Coordination

IQVIA

Ciudad de México

On-site

MXN 450,000 - 750,000

Full time

8 days ago

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Job summary

IQVIA in Ciudad de México is seeking an experienced Clinical Research Associate to perform monitoring and site management across multiple protocols and therapeutic areas. You will ensure GCP/ICH compliance and data integrity at each site.

Responsibilities include conducting monitoring visits, supporting recruitment plans, training site staff, managing TMF/ISF, and mentoring clinical personnel to drive project success while safeguarding patient safety.

Qualifications

Bachelor's degree in scientific discipline or health care preferred.
Requires at least 5 years of on-site monitoring experience, MINIMUM 1 year as a SR CRA.
In depth knowledge of GCP and ICH guidelines.
Strong protocol knowledge as provided in company training.
Strong computer skills: Excel and PowerPoint.
Written and verbal communication skills including good command of English.
Organizational and problem-solving skills.
Effective time and financial management skills.
Ability to establish and maintain effective working relationships.

Responsibilities

Perform site monitoring visits (selection, initiation, monitoring and close-out visits).
Work with sites to drive and track subject recruitment plans.
Administer protocol training to sites and maintain regular communication.
Evaluate site practices for protocol conduct and regulatory adherence.
Track regulatory submissions, recruitment, CRF completion and data queries.
Ensure TMF/ISF documents are filed and maintained.
Create and maintain documentation of site management and visit findings.
Mentor clinical staff including co-monitoring and training visits.
Collaborate with study team for project execution and support recruitment planning.
May support startup activities and site financial management where applicable.