Main tasks:

Applies knowledge of ICON’s policies and procedures

Demonstrates excellent written and oral communication

Demonstrates excellent knowledge of ICH/GCP

Displays ability to manage investigative sites to facilitate trial deliverables

Demonstrates ability to escalate issues appropriately

Conducts monitoring to confirm subject safety and data ntegrity

Describes and demonstrates the principals of IP accountability

Identifies scientific misconduct at the site level

Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS/IWRS and Electronic Data Capture platforms

Mentors CRAs new to the position or company

Serves as an observation visit leader

Conducts monitoring evaluation visits

Assists team lead in the development of trial tools or documents

Requirements:

· Read, write and speak fluent English; fluent in host country language required.

· 1+ years of clinical monitoring experience required

· Knowledge of ICH and local regulatory authority regulations regarding drug

· Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required

· Clinical research experience

· Knowledge of ICH and local regulatory authority regulations regarding drug

· An advanced degree (e.g., M.S., M.B.A., PharmD, etc)

· Experience in monitoring all trial components (PSSV to COV)

· Experience in coaching/mentoring other CRAs