Clinical Trial Associate

Bicycle Therapeutics

Lexington, MA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 04/20/2021
  • Website: bicycletherapeutics.com
  • Company Address: B900, Babraham Research Campus, Cambridge, U.K. , CB22 3AT

About Bicycle Therapeutics

Bicycle Therapeutics is developing a new class of medicines to treat cancer and other debilitating diseases. Bicycle Drug Conjugates are designed to rapidly and selectively penetrate the tumor, delivering toxins directly to where they are needed while minimizing exposure to normal tissue and associated toxicities.

Job Description

    The Clinical Trial Associate will be responsible for administering, coordinating, and maintaining the logistical aspects of Bicycle’s clinical study programs. In this role, they will be responsible for communicating effectively with internal and external study personnel and in facilitating the activities associated with the successful execution of Bicycle’s clinical programs.

Key Responsibilities

    •    Support the clinical study team(s) with the oversight of CROs and management of studies, including planning, execution, and closeout of clinical trials
    •    Assist the Clinical Trial Manager (CTM) in preparing Protocols, Investigator Brochures and other study documents, and track revisions
    •    Support the CTMs in the set up and maintenance of the internal electronic filing systems compliant with regulations and in audit ready state, as well as general study filing
    •    Ensure that tracking tools are developed and maintained throughout the trials for the Clinical Operations teams
    •    Perform lab sample tracking, utilizing the central lab database
    •    Support clinical operations functions during audits e.g BIMO, FDA
    •    Participate in the review and approval of clinical monitoring visit reports in conjunction with the CTM and track outstanding follow up items as requested
    •    Participate in the review and finalization of study plans and circulate for approval
    •    Day-to-day contact with counterpart at CRO; daily review and identification of potential issues or problems with the sites and communicate/escalate to CTM or senior Clinical Operations staff
    •    Perform QC of electronic Trial Master Files
    •    Fully understand the need for and importance of being inspection ready and diligently follow Clinical Operations SOPs; identify and communicate any gaps
    •    Accountable for ensuring that agendas for meetings are clear and distributed in advance; take comprehensive and precise minutes for internal and external meetings
    •    Assist CRO with planning of Investigator Meetings and associated travel
    •    Under the guidance and direction of the Clinical Study Manager, interface with other internal functions to coordinate relevant and timely exchange of information / materials to support clinical trials
    •    Support invoice and budget activities for clinical trials

Key Skills and Competencies

    •    Bachelor’s degree in scientific, biological, life sciences, or related field
    •    At least 2 years supporting clinical studies at a CRO or biopharmaceutical company
    •    Early phase and/or Oncology experience
    •    Familiarity with ICH, GCP, and FDA requirements, as applicable, for clinical trial management
    •    Strong analytical and problem-solving skills
    •    Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment
    •    Excellent written and oral communication skills
    •    Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint)

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.