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.
Typical Accountabilities: • Contributes to the selection of potential investigators.
• In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance.
Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
• Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
• Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study.
• Actively participates in Local Study Team (LST) meetings.
• Contributes to National Investigators meetings, as applicable.
• Initiates, monitors and closes study sites in compliance with client’s Procedural Documents.
Shares information on patient recruitment and study site progress (site quality/performance) within the LST • Drives performance at the sites.
Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
• Updates CTMS and other systems with data from study sites as per required timelines.
• Manages study supplies (ISF, etc), drug supplies and drug accountability.