When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health.
From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient.
We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel are Senior Clinical Research Associates for UK based sponsor dedicated roles.
Experience in oncology trials and RECIST criteria is essential.
A minimum of 4 years' experience in CRO or Pharma trials environments is also essential.
The Senior CRA will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local.
Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for the majority of activities to supplement on site visit requirements.
The Senior CRA will collaborate with the Site Manager to assure that the site complies with the protocol and is inspection ready and will coordinate with institutions and investigators at the local level.
Some specifics.
Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject as.