PRAHS

  • Sr. In-House CRA -Early Development Oncology (Home-Based)

    Job Locations (All) | US-Remote
    Posted Date 2 weeks ago(12/4/2018 7:10 PM)
    ID
    2018-50883
  • Overview

    Would you like to assist in the maintenance of Clinical Drug Studies for one of the largest pharmaceutical companies in the world?

     

    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 an experienced In-House CRA who is responsible for collaborating with the Clinical Project Manager and cross-functional Clinical Study Team to drive successful planning, execution, and analysis of clinical studies.  You will coordinate development of various critical study documents, plans, reports and trackers, including but not limited to clinical planning tools, feasibility, protocol development, case report form development, IRB submissions, investigator agreements, informed consent forms (ICF) development, Investigator Selection, systems (e.g. CTMS, IXRS etc), clinical trial related operational manuals, training materials, and various clinical trial plans (e.g., monitoring, risk mitigation, communication plans, etc) site selection and budget planning.  You 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.

    Responsibilities

    What will you be doing?

     

    The In House Clinical Research Associate (IHCRA) performs 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.

    • Collaborates with Clinical Project Manager and cross-functional Clinical Study Team to drive successful planning, execution, and analysis of clinical studies
    • Coordinates development of various critical study documents, plans, reports and trackers, including but not limited to clinical planning tools, feasibility, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent forms (ICF) development, Investigator Selection, systems (e.g. CTMS, IXRS etc), clinical trial related operational manuals, training materials, and various clinical trial plans (e.g., monitoring, risk mitigation, communication plans, etc) site selection and budget planning.
    • Focus within Early Development (Phase 1) Oncology Studies

    Qualifications

    • Minimum of 2+ years of related experience
    • Substantial experience using computerized information systems, electronic mail, word processing and electronic spreadsheets required.
    • Proven clinical research experience required.
    • Through knowledge of ICH and local regulatory authority drug research and development regulations required.
    • Experience leading a team in a clinical research environment highly preferred
    • Experience leading a team on global clinical trials preferred
    • Experience with study start-up required
    • Oncology experience highly preferred
    • Abilility to travel 10-20%
    • Bachelor's degree in scientific discipline, RN or BSN equivalent
    • 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.



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

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