Clinical Research Associate, Site Management - Italy
IQVIA Inc
Italy
Good clinical practice (gcp)
Ich guidelines
Protocol requirements
Engage in structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits
Job Summary
Engage in structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits.
Under close supervision, perform site monitoring visits (selection, initiation, monitoring and close out visits) in accordance with contracted scope of work and good clinical practices.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
Matching Summary
Engage in structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits.
Skills & Requirements
Must-have
Good Clinical Practice (GCP)
ICH guidelines
protocol requirements
site monitoring visits
clinical research regulatory requirements
Nice-to-have
therapeutic knowledge
project execution support
recruitment plan development
Key Requirements
Bachelor's Degree in scientific discipline or health care preferred
Equivalent combination of education, training and experience may be accepted
Local ministerial decree as per Italian requirements
Prior clinical experience preferred
Computer skills including proficiency in Microsoft Word, Excel and PowerPoint
Written and verbal communication skills including good command of English language
Organizational and problem-solving skills
Effective time and financial management skills
Ability to establish and maintain effective working relationships