PRAHS

SAM Clinical Trial Associate - Boston, MA

Job Locations (All) | US-MA-Boston
Posted Date 1 month ago(6/3/2020 2:21 PM)
ID
2020-63630

Overview

Do you want to watch clinical development change, or do you want to be the one to shape it?

Because we’re hoping you’re here for the latter.

Who are we?

We Are PRA.

We are 17,000+ 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 life saving drugs into the hands of those who need them most.

Who are you?

You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a SAM Clinical Trial Assistant, you want to change the future.  You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. 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.

Responsibilities

What will you be doing? 

The CTA will provide support to the Site Activation Manager (SAM) in the processing and management of regulatory documents during study start-up and amendment release. 

 

  • Exhibits critical thinking skills and the ability to multi-task effectively across multiple protocols
  • Demonstrates a working knowledge of ICH GCP Guidance and study start-up processes
  • Ability to interact well with various team members and provide value added support to project
  • Displays ability to independently solve routine problems following standard policies/procedures
  • Collaborates closely with the SAM to assist in the activation of all assigned study sites according to project timelines
  • Provides support to the SAM at the time of amendment release to ensure all associated documents are collected
  • Collects and reviews site regulatory documents for quality and completeness
  • Ensures regulatory documents are filed to the Trial Master File (TMF) prior to site activation and update Regulatory Greenlight Checklist, as applicable
  • Manages incoming documents through an investigator portal, including linking site-shared documents across studies
  • Responsible for data entry of site-specific metrics and information into internal database
  • Customizes site level documents such as regulatory packages, selection letters, etc.
  • Creates and maintains tools and trackers
  • Attends study team meetings/teleconferences and other department meetings
  • Performs other administrative tasks as delegated

Qualifications

What do you need to have?

Education: Undergraduate degree or its international equivalent in clinical, science, or health related field from an accredited institution or a licensed healthcare professional

 

Skills:

  • Minimum of 2 years of related experience
  • Experience with PC-Windows, word processing, and electronic spreadsheets required.
  • Knowledge of ICH and local regulatory authority drug research and development regulations required.
  • Clinical trials support or pharmaceutical industry experience required
  • Read, write, and speak fluent English; fluent in host country language required
  • Prior experience using computerized information systems.

 

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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