• Study Start Up In-house CRA - Bridgewater, NJ

    Job Locations - | US-NJ
    Posted Date 6 days ago(6 days ago)
  • 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 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 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 Study Start Up In House CRA, 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.



    What will you be doing?


    As a Study Start Up In House CRA, you will perform investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and 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.  At the Senior level, the IHCRA will manage and lead all activities listed above and will ensure that all activities meet Sponsor and PRA expectations and are delivered in accordance with the contract, trial protocol, ICH/GCP and applicable SOPs.


    • Demonstrates good working knowledge of PRA systems and work environment
    • Demonstrates thorough knowledge of clinical research industry standards, practices, and regulations.
    • Exhibits good decision making skills utilizing all available resources for determining positive outcomes.
    • Successfully interacts with both internal and external customers, representing the organization on specific projects.
    • Liaises with internal and external customers to meet project specific goals including participation in sponsor and project
    • related meetings
    • Acts as a liaison with clinical supply/service vendors and other functional area team members to meet project team
    • Identifies, monitors, documents, and tracks out-of-scope activities.
    • Supports Clinical Team Manager (CTM)/Start Up Lead (SUL) and Clinical Research Associate (CRA) in the management
    • of investigational sites to ensure compliance with study timelines, the trial protocol, ICH/GCP and applicable regulations.
    • Assists with Investigational Product accountability, subject screening/enrollment, Case Report form retrieval and query
    • distribution to/from investigational sites.
    • Proficient in the development and review of Informed Consent Form templates.
    • May serve as an Independent Essential Document Reviewer and/or perform second review of Essential Documents .
    • Assists in the creation and maintenance of clinical project documents including, but not limited to Clinical Management
    • Plans, monitoring Guidelines, Site Operations Manuals, Monitoring Visit Letter templates and Project Start-up Plans
    • under the guidance of the SUL/CTM.
    • Supports the CTM/SUL/CRA to resolve internal and external clinical issues for client research projects managed by PRA.
    • Interacts with site, clients, vendors and PRA functional areas as secondary project contact for site issues and questions.
    • Supports CTM/SUL/CRA in the management of clinical budget and evaluation of study processes.
    • Evaluates metric data to identify process improvements.
    • Assists with managing and training staff.
    • Manages time and project requirements based on study contract.




    What do you need to have?

    Education: Undergraduate degree or its international equivalent in clinical, science, or health related field



    • Read, write, and speak fluent English; fluent in host country language required
    • 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.


    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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