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Clinical Research Associate II/ Clinical Site Manager II - Midwest at Parexel

Posted in Other 30+ days ago.

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Type: Full Time
Location: Waltham, Massachusetts

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
- Build strong working relationships with investigators and site staff
- 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 mannerQualifications
Your Skillset:
- At least 2 years of on-site monitoring experience
- Educated to degree level (biological science, pharmacy or other health related discipline)
- Strong written and verbal communication skills in 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!EEO DisclaimerPAREXEL is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.