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    Summer Internship, Clinical Operations - Cambridge, United States - Beacon Therapeutics (USA) Inc

    Beacon Therapeutics (USA) Inc
    Beacon Therapeutics (USA) Inc Cambridge, United States

    4 weeks ago

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    Description

    Job Description

    Job Description

    Mission

    The Clinical Operations Summer Intern will be a remote position working on understanding the role of clinical operations in initiating and managing clinical trials within ophthalmology. The intern will be expected to gain operational knowledge regarding current clinical trials at Beacon Therapeutics and apply learnings towards initiating/tracking of clinical site activities and associated clinical documentation.

    2024 Internship Program Dates (one of the following options):

      • Monday, May 20 - Friday, August 9
      • Tuesday, May 28 - Friday, August 16
      • Monday, June 3 - Friday August 23

    Reporting Relationship

    • The Clinical Operations Intern will report to the Senior Clinical Operations Manager or designee.

    Duties and Responsibilities

    • Supports the Clinical Operations team in the review, maintenance, distribution, and archiving of clinical study documents and reports.
    • Assists with the maintenance of the Trial Master File (TMF) in compliance with ICH, GCP and the Company's SOPs. This may include the review and tracking of clinical trial documents in coordination with vendors and the CRO.
    • Updates the Essential Document Tracker in a timely manner ensuring study and site documents are filed within the TMF upon receipt.
    • Assist in the creation and maintenance of internal tracking tools used to manage assigned studies/sites.
    • Assist with the processing of purchase orders, invoicing and other vendor/site documents as needed.
    • Assists with the management of site study supplies, including the ordering, tracking and shipment of study equipment/materials and investigational product.
    • Will attend company meetings, clinical operations meetings, and any other meetings as needed.
    • Will attend 1:1 weekly meeting with mentors/supervisor.
    • Assisting with special projects and/or tasks, as required.
    • Intern will be expected to work M-F, 8 am to 5 pm with a 1-hour lunch break, not to exceed 40 hours per week. This position is not benefits eligible.
    • This job description is subject to change at any time.

    Educational Qualifications

    • A currently enrolled university or college student that has completed at least their second year working towards a Science, Engineering or Business degree.

    Additional Qualifications

    • Attention to detail; good planning and organizational skills.
    • Ability to maintain confidentiality.
    • Experience with Microsoft Office Suite and SharePoint (preferred).
    • Excellent written and oral communication skills, as well as time management skills.
    • Demonstrates the ability to multitask under compressed deadlines across several projects, each with unique requirements.

    Physical Requirements

    • Physical demands: (check one)

    ☒ sedentary (< 10 lbs.)

    ☐ light work (< 20 lbs.)

    ☐ medium work (< 50 lbs.)

    ☐ heavy work (< 100 lbs.)

    ☐ very heavy work (>100lbs.)

    • Physical activity: (check all that apply)

    ☒repetitive motion

    ☐ balancing

    ☐stooping

    ☐lifting

    ☐climbing

    ☐kneeling/crouching

    ☐crawling

    ☐reaching

    ☒standing

    ☒ typing/grasping

    ☒walking

    ☐pushing/pulling

    ☒hearing

    • Visual acuity (preparing/analyzing data, transcribing, reading, and writing)
    • Working conditions (indoor office environment)


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