MSI is looking for Experienced Clinical Research Associates who are looking to grow with a Global CRO based in the USA.
It is a homebased role with regional travel and the CRO is offering roles within exciting therapeutic areas!
Education and Experience:
- Minimum 3+ year of Independent, on-site monitoring experience in a Pharmaceutical or Clinical Research Organisation
- Ability to manage required travel of up to 60% on a regular basis
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
What you'll do
- Leverage your expertise. Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit/contact reports.
- Build relationships. Oversee integrity of the study and utilize problem-solving skills to promote rapport with the site and staff.
- Protect patients. Review the performance of the trial at designated sites, ensure the rights and well-being of human subjects are safeguarded and are in accordance with protocol.
- Drive productivity. Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines while also Ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s).
- Ensure quality. Evaluate the quality and integrity of the reported data, site efficacy and drug accountability.
- Execute. Monitor completeness and quality of Regulatory Documentation and perform site document verification.