Clinical Trial Associate

1 week ago


Waltham, Massachusetts, United States Beacon Hill Life Sciences - Boston Full time
Job Description

Beacon Hill Life Sciences - Boston is seeking a highly skilled Clinical Trial Associate to join our team. As a Clinical Trial Associate, you will play a critical role in the execution of clinical trials, working closely with our Clinical Trial Managers to ensure the successful conduct of studies.

Key Responsibilities:

  • Organize and maintain tracking systems to support the conduct of clinical studies from start-up to close-out.
  • Assist with the development and review of clinical documents, including protocols, ICFs, and clinical study plans.
  • Schedule and coordinate study meetings, materials, and agendas, recording and disseminating decisions and actions.
  • Coordinate and manage version control of clinical documents, prioritize multiple tasks and/or projects with limited supervision.
  • Facilitate vendor engagement from RFP distribution through to final contracting and PO setup.
  • Setup and organize Sharepoint and central study files.
  • Coordinate training for assigned clinical studies.
  • Manage study laboratory sample tracking and vendor management support.
  • Assist in coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation Packages.
  • Support Clinical Operations team with specific projects.
  • Effectively communicate with study team members and work closely to address challenges.

Requirements:

  • BS/BA degree or equivalent and at least one year of experience in clinical operations in a Sponsor company with 1+ years strongly preferred.
  • Knowledge of drug development, clinical operation processes, and documentation, including study start-up procedures, maintenance phase, and study close-out procedures.
  • Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations.
  • Experience with eTMF; ability to directly apply essential document knowledge to file documents.
  • Effective communication, organizational, and interpersonal/team skills.
  • Proficient in MS Excel, Word, and PowerPoint. Knowledge of MS Project and SharePoint preferred.
  • Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines.
  • Participate in inter-departmental workgroups to create or enhance processes.
  • Strong attention to quality/detail.
  • Good organizational and time management skills.
  • Willingness to work in a flexible environment.

Preferred Qualifications:

  • Experience with global studies, using an outsourced CRO model.
  • Experience in clinical drug development with knowledge of First in Human trials.
  • Experience with regulatory affairs, including IND/CTA submissions.
  • Experience working on dermatology.


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