Parexel International Work Values

Daily Duties at Parexel International:

• Conducted all aspects of site monitoring including qualification, initiation, active-phase, and termination visits in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products. • Conducted study-specific site staff and CRA training visits at global study sites. • Built client relations via frequent teleconferences, study status updates, trouble-shooting. • Prepared, participated in, and followed-up on site audits/inspections. • Monitored clinical trials in both EDC and paper-based environments. • Assisted with all aspects of site regulatory document review and preparation required prior to and following site initiation. Including but not limited to Informed Consent design and review, site regulatory package review and approval. Coordinated submission to Central IRBs on behalf of sites. • Tracked study drug supply, distribution, and re-supply needs between ex-North America depots and sites. • Reviewed study-specific peer site visit reports, provided feedback, and finalized for submission to client.

What they like about Parexel International:

Working in an organization that is technologically advanced, creative, and innovative is critical in your assessment of hiring companies. Less important to you are stability of the organization, the length of time an organization has been in business, and the business' plans for the future. You prefer a fast-moving company that will take risks to achieve its goals and objectives. The length of time the company has been in business is irrelevant. Maintaining status quo is unnecessary. You thrive on change, uncertainty and the upside of potential business risks, especially those associated with innovation. Stability for the long haul is not nearly as important as is working in an atmosphere that is charged with a sense of urgency and constant change.

Tags

CCRA, Florida, southeast, oncology, manager, IMPACT, RAVE, Phase I, Phase II, Phase III, CTMS, audit, CRA, clinical, research, associate, senior, experienced, management

Skills

Clinical Trial Management, Audit Response, Clinical Trial Management Systems, Electronic Data Capture, Contracts and Budgets - Creation and Management, Monitoring, Pharmacokinetics and Pharmacogentics, Investigator Payments - Schedule and Management, Data Lock Timelines, Recruitment Plans and Contingencies, Monitoring Plan Development and Execution, Corrective and Preventive Action Plan(s) - CAPA(s), Blinded Trial Management, Oral and IV Drug Accountability, Informed Consent Development

These are some of the questions we asked our climbers about their experiences with Parexel International: