Our clinical monitoring department defines and develops clinical programs. We ensure the highest-quality review of data and effective interaction with study sites, including on-site monitoring throughout a study. Our clinical research associates (CRAs), remote site monitors (RSMs), clinical trial coordinators (CTAs), and client-dedicated teams oversee and administer the health and efficacy of treatments during trials. We support the logistics and organization of clinical sites — ensuring that patients receive needed care, as well as identifying and treating clinical trial participants.
Every person on our team works with our systems and communicates with the central project team and many colleagues in various departments.
As part of our traveling team of clinical research associates (CRAs), you will visit medical staff at different sites checking the documentation and process quality at each site to make sure patients are protected and that data are correct. Our CRAs work closely with our sites and study teams to ensure quality study data, and that the quality of our work can withstand scrutiny. You probe data, inspect root causes of any issues, seek clarification, develop a clear plan of action and communicate internally and externally.
As the in-office point of contact for medical staff, remote site monitors (RSMs) ensure that site staff have quick answers to their questions. In this challenging role, you will monitor activities on assigned projects in accordance with federal, local, industry and PPD regulations, guidelines and procedures. You will remotely review study data from various sources, contact study sites to collect study documentation, proactively seek customers’ perspectives, anticipate needs, identify root causes and resolve issues. You will be empowered to make decisions for the good of PPD and our clients, and to freely share information and resources.
As a clinical trial coordinator (CTA), you will handle clinical monitoring documentation — confirming that the correct documents are where they should be. You provide administrative and technical support to your project team, perform PPD investigator file reviews, draft meeting minutes, prepare communications to sites, process regulatory documents, perform clinical trial management system data entry, update vendor trackers and maintain data repositories.
Work exclusively for one of our strategic pharmaceutical partners to collaborate with the client’s teams, systems and processes on behalf of PPD. As part of our functional service provider (FSP) team, you will interact directly with clients. You might be fully integrated into a client’s team, systems and processes, working to their way of delivering projects. Or you might be placed on an FSP project, to which you’ll contribute to meeting the client’s needs and to the wider FSP group. In all instances, you will be customer focused and represent PPD, in addition to receiving our support and management.