Would you like to assist in the maintenance of Clinical Drug Studies for one of the largest pharmaceutical companies in the world?
Who are we?
We Are PRA.
We are 15,000+ employees strong, operating in more than 85 countries. We are committed to saving lives, and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.
Who Are You?
You are an experienced Clinical Study Assistant who is responsible for tracking and maintening study activities including in-house management of documentation generated by the clinical sites. You handle regulatory documents and help to review Clinical Study Contracts and Budgets. You provide excellent support to not only your project teams but also to clients. You are excited and enthusiastic. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.
Still here? Good. Because if this is you, we’d really like to meet you.
Provide support to the trial team in all phases of the clinical study conduct, including maintaining key information in clinical study systems in accordance with ICH-GCP guidelines, US Food and Drug Administration requirements, and Quality System documents. This position closely collaborates with other team members in addition to the Trial Management Team -Documentation Group, Global Clinical Operations Administrative Support, CRAs, Clinical Monitoring Managers.
• Updates and maintains clinical study systems
• Assists Global Trial Manager clinical study site payments and invoices processing
• Prepares site related documents e.g., Investigator Site Files
• Prepares, handles, distributes, and files clinical study documentation and reports
• Orders, distributes/ships, and tracks study related non-clinical supplies
• Works closely with Administrative Support Group for shipments and other routine tasks (e.g., ISF binder preparation)
• Handles and processes site contracts, including obtaining signatures
• Files/uploads documents into systems
• Maintains and updates site and user contact lists for External Service Providers
• Performs administrative tasks to support Trial Management team members with clinical study execution (e.g., Schedule meetings, assist with Investigator meetings, prepare agendas, and meeting minutes)
• May act as a central contact for the trial team for designated project communications, correspondence, and associated documentation
• Reviews study reports
• Performs quality checks of the (e)TMF or other study documents
• Assists at Investigation meetings
• Performs quality checks and review of the TMF in accordance with QS docs
• Audits and resolve issues of redundancy, currency, and consistency of documents on shared drives and portal
• Performs other duties as assigned
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.