- | US-NJ | US-NY
5 days ago
Study Start Up CPA - Office Based (New Jersey)


You will be helping to support the management and oversite of Clinical Drug Studies for one of the largest pharmaceutical companies in the world.


Are you still interested?


Who are we?

We Are PRA.


We are 13,000+ 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 Project Assistant who is responsible for operational support of Clinical Studies. You help with the oversite of vendor management, study reports and site follow-up. You can 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.


What will you be doing?

You will be responsible for supporting clinical trials related to study start up activities. You must have a strong backround and knowledge of study start up activities and regulatory documents. You will be responsible for supporting multiple clinical trials in North America. You will have a wide variety of responsibilities - we are including some of the biggest:

  • Shipping SSU binders and CDs to sites within appropriate amount of time
  • Assist with the review of SSU templates completed by study manager
  • Create records and tracking
  • Supports SSU team with any other tasks in order to improve the timelines and the overall SSU experience


What do you need to have?

  • 0 – 2 years of related experience
  • 2+ years of Study Start Up Experience preferred 
  • Proficient with Excel- ability to create pivot tables 
  • Experience with Sharepoint required
  • Prior experience using computerized information systems
  • Read, write, and speak fluent English; fluent in host country language required 
  • Undergraduate degree or its international equivalent in clinical, science, or health related field from an accredited institution or a licensed healthcare professional
  • 4 year degree preferred 
  • Clinical trials support or pharmaceutical industry experience preferred
  • Experience with PC-Windows, word processing, and electronic spreadsheets preferred
  • Office based or clinical employment experience preferred.
  • Knowledge of ICH and local regulatory authority drug research and development regulations preferred
  • Organized, flexible, able to prioritize and adapt with competing tasks
  • Team-centric and self-motivated; go-getter

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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.


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