PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Post: Clinical Research Associate II
Job Description:
- 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
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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
Candidate Profile
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 language
Additional Information:
Experience: min. 2 years
Education: degree level
Location: USA
Industry Type: Pharma/ Biotech/Clinical Research
Req ID: 00022878
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