Radius Health, Inc.

  • Clinical Research Associate

    Job Locations US-MA-Waltham
    Posted Date 2 months ago(3/20/2018 12:12 PM)
    Job ID
    2018-1701
    # of Openings
    2
    Category
    Clinical Ops - Dept
  • Overview

    The in-house Clinical Research Associate (CRA) will assist the clinical operations project lead and the clinical team with day to day clinical study conduct activities per project team objectives. The ideal candidate will have keen attention to detail and the ability to both prioritize and handle multiple tasks effectively in a rapidly growing company environment. The CRA will support the development programs for the osteoporosis or oncology therapeutic area.

    The CRA will be expected to participate in the processing and performance of quality assurance checks of clinical trial data to ensure data integrity and consistency across clinical programs and in accordance with Radius standard operating procedures and Good Clinical Practices (GCP).  

    Responsibilities

    • Co-monitors or performs sponsor visits to the study sites with the assigned CRAs as required
    • Reviews monitoring visit report reviews and escalates issues to clinical operations project lead as appropriate.
    • Leads day to day support activities, including tracking and creating overviews of subject, site, study status, milestones; performs quality check activities across components of the clinical study including progress of internal and external stakeholder activities (i.e. PV, Supply Chain, CRO, third party vendors, etc.)
    • Navigates EDC and IRT systems and completes data reviews as needed to meet project objectives
    • Performs verification and quality control of essential regulatory documents and is well versed in the organization of a trial master file.
    • Assists with the set-up of the clinical database (UAT Testing)
    • Creates & maintains study specific tracking tools and project files as needed.
    • Assist in managing investigational product supplies at the country (where applicable) and trial site level, keeping sites informed of drug lots/batches and expiration dates. Ability to review and perform drug accountability if required.
    • Assist in the preparation of site and in-house Sponsor inspections.
    • Maintains/develops a good level of scientific knowledge within the Project’s therapeutic area.
    • Effectively communicates with study team members and works closely to address challenges.
    • Assists with NDA activities as needed.
    • Helps to identify, create & establish study tools for department
    • Consistently performs duties within established Standard Operating Procedures, and in accordance with Good Clinical Practices.

     

    Qualifications

    • Required Bachelor’s degree, in a health science related field is preferred
    • 2-4 years of clinical research experience at a CRO or Biotech/Pharmaceutical company, at least 1 year of on site clinical trial monitoring or clinical study coordinator experience is preferred.
    • Oncology or osteoporosis experience a plus

     

    • Solid understanding of study trial design, trial execution and operations (including creating study tools).
    • Excellent computer skills (Microsoft Office Word, Excel, Outlook) required.
    • Good organizational & time management skills
    • Willingness to work in a flexible environment
    • Sound working knowledge of knowledge of the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines and other applicable regulatory guidelines required.
    • Global trial experience a plus.
    • Some travel required (as needed basis; not continuous).

    Radius is a science-driven biopharmaceutical company focused on developing new therapeutics for patients with osteoporosis as well as other serious endocrine-mediated diseases.

    Radius is committed to the research and development of new therapeutics for the large and underserved osteoporosis market. The Company's lead investigational drug product candidate, abaloparatide (BA058), is in development, in both injection (Abaloparatide-SC) and transdermal (Abaloparatide-TD) methods of administration, for the potential prevention of fractures in post-menopausal women at risk of fracture from osteoporosis.

     

     

     

     

     PM18

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