Clinical Research Associate II

Job Description

PAREXEL provides monitors with world class technology, training resources, and limited protocol load. You will also be rewarded for your hard work through our CRA bonus incentive program and career advancement opportunities.

Your Key Accountabilities:

Perform all clinical monitoring/site management activities for assigned projects in accordance with PAREXEL's standard operating procedures
Act as PAREXEL's direct contact with assigned clinical sites, and use judgment to assess and ensure overall integrity of study implementation, as well as adherence to study protocol
Conduct qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites
Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Function as a mentor and role model for other CRA team members
Manage clinical monitoring activities, including:
Arranging on-site visits and logistics
Establishment of a site recruitment plan in collaboration with site staff during QV
Monitoring completeness and quality of Regulatory Documentation
Performing site documentation verification
Data collection and drug accountability in accordance with ICH GCP guideline
Monitoring patient safety on-site and addressing any violations in a timely manner

Our Offer:

We offer you a fascinating and diversified insight into PAREXEL and an exciting journey through the world of clinical research.

You can expect to work with a successful, highly-qualified and dynamic team as you develop your individual scientific profile. You can also look forward to a flexible working environment and a pleasant atmosphere.
Job Requirements
Your Skillset:

Minimum 2 years of monitoring experience in clinical research
Educated to degree level (biological science, pharmacy or other health related discipline)
Strong working knowledge of EDC systems and IVRS
Experience of CTMS preferred
Competent in written and oral English and French
Employer Contact Information
Karolina Madejska


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