• In-house CRA - East Hanover, NJ

    Job Locations (All) | US-NJ
    Posted Date 2 weeks ago(10/4/2018 10:40 AM)
  • Overview

    Who are We?

    We Are PRA. 


    We are over 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 help get life-saving drugs into the hands of those who need them most. 


    Who are you? 


    You are the TMF subject matter expert in your field, and yet, people contact you with questions that fall outside your jurisdiction because they know you will leverage every resource you have to get them the answers they need.  You have excellent communication & follow-up skills, you dot your “i’s” and cross your “t’s,” and there’s just something about tasks that tap into your innate process orientation that make your heart go pitter-patter. 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. 


    Still here? Good. Because if this is you, we’d really like to meet you.


    What will you be doing?  


    • The In House CRA  is accountable for the overall quality, completeness and timely processing of core regulatory documents, the overall electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS) from Site Selection until Site Close. The ideal candidate will drive optimization of efficiency to reduce study start-up time, ensure audit-ready eTMF preparedness and compliance with regulations. Timely delivery of high quality regulatory documents in accordance with timelines and compliance to internal standards and external GCP/ICH guidelines and FDA regulations.


    What do you need to have?

    • 0 – 2 years of related experience
    • 1-3 years’ experience or equivalent competencies in clinical research including a working knowledge of clinical/regulatory development process; study start-up experience preferred
    • 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 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
    •  Good understanding of TMF document types and the ability to distinguish and segment these documents, 

    • Experience with document management repository systems including workflows, scanning and imaging 
    • Proven strong Microsoft Office skills (i.e. Excel, PowerPoint) 
    • Proven ability to meet timelines and manage work independently by working unilaterally or within teams
    • Detail oriented with superior organization and documentation skills
    • Knowledge of Process Improvement Methodology preferred. 
    • Ability to multi-task and prioritize multiple high-priority projects
    • Strong capability in working in a matrixed environment
    • Provide excellent communication and interpersonal skills/experience with strong customer service orientation.

    • Strong interpersonal, negotiation and conflict resolution skills

    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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