Clinical Research Associate II/ Clinical Site Manager II - Southeast at Parexel
Posted in Other 30+ days ago.
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Type: Full Time
Location: Waltham, Massachusetts
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 mannerQualificationsYour 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 local languageOur 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.