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Clinical Trial Associate

If interested and qualified, please include Requisition # 2017-240 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.

Position Summary

Reporting to the Head of Clinical Operations. The Clinical Trial Associate (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, Good Clinical Practice (GCP), and CRISPR Therapeutics standard operating procedures (SOPs). The CTA will support the Head of Clinical Operations and Clinical Trial Managers (CTM) 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
  • Schedule and coordinate study meetings, materials and agendas; recording and disseminating decisions and actions
  • Responsible for quality control of the eTMF including maintenance and oversight
  • Coordinate training for the Clinical Operations department
  • Responsible for study laboratory sample tracking and vendor management support
  • Set up, manage, and track new vendors and purchase orders in financial system
  • Coordinate and manage version control of clinical documents, prioritize multiple tasks and/or projects with limited supervision
  • Assemble pharmacy and lab manuals as appropriate
  • Assist in coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation Packages
  • Organize and maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out
  • Support Clinical Trial Managers and Head of Clinical Operations 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 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 & 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 trial
  • Experience with regulatory affairs, including IND/CTA submissions
  • Knowledge of transplant or cellular therapies

Competencies

  • Perseverance – Pursues tasks with energy, drive and initiative, even in the face of adversity.
  • Results Oriented – Drives issues to closure and gets the job done.
  • Effective Planning - Embedding discipline and thoroughness in our approaches.
  • Adaptability/Flexibility - The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands.
  • Communication and Teamwork - The ability to effectively express ideas in written and oral context. The ability to work co-operatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals.

If interested and qualified, please include Requisition # 2017-240 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.