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Clinical Research Associate / Sr. Clinical Research Associate (In-House)

If interested and qualified, please include Requisition # 2017-237 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 In-House Clinical Research Associate (CRA) will support the Clinical Trial Manager (CTM), the regional clinical monitoring team and clinical site personnel 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. The candidate will be a critical member of the study team and will interface with multiple functional groups internally including research, CMC, DM/Biostatistics, supply chain and regulatory.

Responsibilities

  • Able to lead day to day support of study operations, including tracking and creating overviews of subjects, sites, study status, milestones and performing quality check activities across components of the clinical study and in conjunction with the CRO and other project associated vendors.
  • Perform verification and quality control of essential regulatory documents and oversee CRO delegated to manage trial master file.
  • Responsible for cellular product traceability and sample tracking from sites to central labs.
  • Develop clinical trial materials for sites, e.g., mini-protocols, study information sheets, checklists, and other documents).
  • Review clinical trial documents, including protocols, informed consent forms, and other documents.
  • Manage the process of setting up vendors in financial systems, and track vendors through set-up, purchase orders, and invoice tracking.
  • Rout documents for Legal review and track status, including Confidentiality Disclosure Agreements, Clinical Trial Agreements, and other documents.
  • Be able to navigate EDC systems and review data as needed to meet project objectives. Co-monitor as required for important data related timelines.
  • Create and maintain study specific tracking tools and project files as needed.
  • Develop and maintain a good level of scientific knowledge within the Project’s therapeutic area.
  • Effectively communicate with study team members and work closely to address challenges.
  • Help identify, create, and maintain study tools for department
  • Consistently perform duties within established SOPs, and in accordance with GCP.
  • Provide support to the Head, Clinical Operations with ad-hoc tasks as required.

Minimum Qualifications

  • Required Bachelor’s degree, in a health science related field is preferred
  • 3-4 years of CRC/CRA experience at a CRO or Pharmaceutical company
  • Solid understanding of study trial design, trial execution and operations (including creating study tools)
  • Excellent computer skills (Microsoft Office Word, Excel, Outlook) required
  • Good organizational & time management skills
  • Willingness to work in a flexible environment
  • Sound working knowledge of knowledge of the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines and other applicable regulatory guidelines required
  • Some travel required (as needed basis; not continuous)

Preferred Qualifications

  • Experience with global studies, using an outsourced CRO model
  • Experience in clinical drug development including phase 1
  • Ability and experience to work with an electronic case report form (eCRF)
  • Experience with drug development in rare genetic disease/hematology/oncology or transplant
  • Experience with regulatory affairs, including BLA and IND submissions

Competencies

  • 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.
  • Effective Planning - Embedding discipline and thoroughness in our approaches.
  • Results Oriented - Drives issues to closure and gets the job done.
  • Risk and Compliance Management - Demonstrates great attention to detail and assures appropriate output. Identifies situations where risk may arise and implements risk mitigation processes and strategies.

If interested and qualified, please include Requisition # 2017-237 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.