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Investigation Specialist

Akebia Therapeutics

Investigation Specialist

Cambridge, MA
Internship
Paid
  • Responsibilities

    Clinical Development Department at Akebia Therapeutics is seeking an intern to be play an integral role in many ongoing activities. This opportunity shall serve as a learning opportunity to drug development in the pharmaceutical industry. The intern will be exposed to clinical trials design, execution as well as involvement in New Drug Application (NDA) activities. Although being based within Clinical Development, cross-functional activities may include interactions with Biostatistics, Drug Safety and Pharmacovigilance, Regulatory Affairs and Clinical Operations.

    Required Skills

    • Participate in the development and quality review of study protocols, protocol synopses, abstracts, clinical data presentations, and manuscripts
    • Retrieve, synthesize and interpret the scientific literature and generate evidence as needed
    • Support medical monitoring activities of ongoing clinical trial
    • Assist in the preparation of clinical development presentations used at internal and external meeting forums
    • Participate in reviewing, summarizing and presenting clinical trials results from TLFs of completed and ongoing trials.
    • Participate in weekly 1 on 1 meetings with the clinical development mentor
    • Present an intern experience presentation at end of program

    Required Experience

    • Advanced degree (MD, PhD, Masters) preferred. Master and doctoral candidates who have at least 3-5 years of clinical research experience are welcome to apply
    • Experience in clinical trials, epidemiologic or clinical research is required
    • Master and doctoral candidates, GPA of 3.0 or above is required
    • Must have completed at least 20 credit hours of epidemiology, biostatistics, data analysis or other related coursework.
    • Legally authorized to work in the U.S. with ease of access to reliable internet, zoom, and phone as this will be a remote internship

     

    Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people with kidney disease. The company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com.

     

    Akebia Therapeutics is an equal opportunity employer and welcomes all job applicants.  All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

  • Qualifications
    • Participate in the development and quality review of study protocols, protocol synopses, abstracts, clinical data presentations, and manuscripts
    • Retrieve, synthesize and interpret the scientific literature and generate evidence as needed
    • Support medical monitoring activities of ongoing clinical trial
    • Assist in the preparation of clinical development presentations used at internal and external meeting forums
    • Participate in reviewing, summarizing and presenting clinical trials results from TLFs of completed and ongoing trials.
    • Participate in weekly 1 on 1 meetings with the clinical development mentor
    • Present an intern experience presentation at end of program
  • Industry
    Transportation / Trucking / Railroad