Senior CRA: Site Monitoring & Study Oversight

IQVIA LLC

Milano

In loco

EUR 34.000 - 67.000

Tempo pieno

14 giorni+

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Descrizione del lavoro

IQVIA LLC is seeking a Clinical Research Associate responsible for site monitoring and study management to ensure protocol adherence, data quality, and regulatory compliance across assigned sites in Italy. You will conduct monitoring visits, manage recruitment plans, and coordinate with site staff, with IQVIA's global leadership in clinical research services.

The role requires solid GCP/ICH knowledge, 3+ years on-site monitoring experience, and strong communication skills in English; proficiency

Competenze

Bachelor's and Master's Degree in scientific discipline or health care.
At least 3 years of on-site monitoring experience.
CRA Certification according to Ministerial Decree dated 15.11.2011.
GCP and ICH guidelines knowledge.
Strong written and verbal English communication.
Microsoft Word, Excel and PowerPoint proficiency; basic device familiarity.

Mansioni

Perform site monitoring visits (selection, initiation, monitoring and close-out).
Drive and track subject recruitment plan to enhance predictability.
Administer protocol training and maintain site communications.
Evaluate site adherence to GCP/ICH and regulatory requirements.
Track regulatory submissions, recruitment, CRF completion and data queries.
Maintain TMF and ISF documents per regulatory requirements.
Document findings and action plans; prepare visit reports and follow-up letters.
Collaborate with study team for project execution; support startup if needed.