Clinical Trial Associate

Beacon Hill - Job Details
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Clinical Trial Associate

Cambridge, Massachusetts

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Full Time Temporary/Contract

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NA

Cambridge, Massachusetts

Full Time Temporary/Contract

NA

November 09, 2022

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Job ID: P1314582BOSJB_1668022643

November 09, 2022

Job ID: P1314582BOSJB_1668022643

Job Summary

Job Id: P1314582BOSJB_1668022643 Apply Now

The CTA position will assist with daily clinical trial execution activities including the coordination of documents associated with the conduct of investigational clinical studies in accordance with applicable regulations, GCP, and company's standard operating procedures (SOPs). The CTA will support the Director of Clinical Operations and Clinical Trial Managers in day to day activities for managing clinical trial conduct. The ideal candidate will have keen attention to detail and has the ability both to prioritize and handle multiple tasks effectively in a rapidly growing company environment.

Responsibilities

  • Collect trial information and disseminate it to the internal project team, the CRO, and other stakeholders
  • Organize/maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out
  • Coordinate training for the assigned clinical study
  • Schedule and coordinate study meetings, materials and agendas; recording and disseminating decisions and actions
  • Responsible for internal meeting agendas/minutes as applicable
  • Responsible for updating, maintaining and quality control of the eTMF, SharePoint site and shared drive
  • Responsible for study laboratory sample tracking and vendor management support
  • Set up, manage, and track new vendors and purchase orders in financial system
  • Assist in coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation Packages
  • Coordinate and manage version control of clinical documents, prioritize multiple tasks and/or projects with limited supervision
  • Support Clinical Operations team with specific projects
  • Effectively communicate with study team members and work closely to address challenges


Minimum Qualifications

  • BS/BA degree or equivalent and at least one year experience in clinical operations in 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
  • Knowledge of transplant, oncology or cellular therapies
P1314582BOSJB_1668022643

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About Beacon Hill

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

We look forward to working with you.

Beacon Hill. Employing the Future™