Posted to MedZilla on 11/18/2017


Parexel

United States-, Clinical Research Associate II (Agency Submittals) post_00023139-MZ


 
 

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 guidelines
    • Monitoring patient safety on-site and addressing any violations in a timely manner

Qualifications

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 with CTMS preferred
  • Competent in written and oral English and local language
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.

If you are ready to join PAREXEL s Journey, please apply!



MZ-103

EEO Disclaimer

PAREXEL complies with all applicable federal, state, and local laws prohibiting discrimination in employment. All qualified applicants will receive consideration for employment without regard to gender, age, race, color, religious creed, marital status, sexual orientation, national origin, ethnicity, ancestry, citizenship, genetic information, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.

Please visit our website at parexel.com

 
 


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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.