PRAHS

Returning Candidate?

2017-41164

2017-41164

Title 
In-house CRA - Blue Bell, PA
Job Locations 
-
US-PA-Blue Bell
Posted Date 
11/17/2017

More information about this job

Overview

Who are we?

We Are PRA.

 

We are 13,000+ employees strong, operating in more than 80 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 help get life-saving drugs into the hands of those who need them most.

 

Who are you?

 

Whether you work at a research site, with a sponsor or at another CRO, you are known to friends and colleagues alike as the “go-to” person.  You have excellent communication & follow-up skills.  With your commitment to executing projects in accordance with the highest standards, you hold a certain reverence for the regulatory processes, SOPs and document trails that map out a pathway to compliance. But most of all, you are someone with tremendous potential who wants to apply your many talents in a role that will expand your fundamental knowledge of clinical research and provide you with the options and training to continue to grow in your career. 

 

Responsibilities

What will you be doing?

 

As an IHCRA, you are the primary point of contact/liaison for the sites, Sponsor and internal stakeholders during the study life cyle.  You will perform investigative site recruitment/feasibility, essential document collection and review, maintenance and close-out in-house site management activities in accordance with the Sponsor and/or PRA protocol, standard operating procedures (SOPs), ICH/GCP guidelines and all applicable regulatory requirements.  Senior-level IHCRAs will manage all activities listed above, ensure that they meet Sponsor & PRA expectations, and deliver them in accordance with the contract, trial protocol, ICH/GCP and applicable SOPs. 

Qualifications

What do you need to have?

  • 2+ years of study start-up or related experience preferred
  • HS diploma required; 4 year degree is preferred
  • Experience using computerized information systems and standard application software (Windows, MS Office)
  • Excellent written and oral communication skills
  • Knowledge of ICH and local regulatory authority drug research and development regulations preferred
  • Clinical trials support or pharmaceutical industry experience strongly preferred

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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