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Clinical Study Associate (H/F/X)

January 22nd 2024

cellcaCellCarta is a rapidly growing, stable company. We are a leading provider of pre-clinical and clinical trial services to pharmaceutical and biotechnology companies. Our laboratory service offerings include immunohistochemistry, FISH, CTC isolation and characterization, chemosensitivity testing, tissue procurement, flow cytometry, ELISA, mutation testing, cell expansion, and colony-forming assays. CellCarta is a CLIA-licensed and CAP-accredited laboratory, and we perform studies in compliance with the relevant portions of Good Laboratory and Good Clinical Practices.

Mission Description

Summary

As a CellCarta Clinical Study Associate (CSA) you are part of the Clinical Operations team and will support the Project manager through a varying packet of tasks linked to sample review, querying and release for testing as well as tasks linked to study conduct and/or set-up. Your day will be filled with administrative tasks thereby embodying 3T’s i.e. always keep the project on Task, on Track and on Time.

Roles & Responsibilities

Below is a non-limitative list of accountabilities.

  • Sample review and release
    • Review of patient sample documentation to check if sample conforms to study-specific guidelines
    • Preparation of data queries in case missing or conflicting information is found
    • Follow up of answered queries
    • Release samples in the correct testing flow
    • Collaborate close with the biosample management and project management team
  • Study conduct
    • Keep study account information up to date within a Laboratory Inventory Management System (LIMS - StarLIMS) and Customer Portal 
    • Prepare shipment requests through LIMS (StarLIMS) 
    • Support with image transfer requests
    • Prepare BioAnalytical Reports for review by the Project Manager
    • Support with study closure activities 
    • Support with Data Entry in systems like Medrio
    • Support with signature collection, audits, document filing, etc
  • Study set-up
    • Preparation of applicable study documentation ensuring that all processes from sample accessioning up to result reporting can run smoothly.
    • Completion of the study set-up within a Laboratory Inventory Management System (LIMS - StarLIMS). This includes but is not limited to: preparation of flows for automated test assignment, devising of quality controls to check that samples meet study-specific requirements.
  • Participate in process improvement initiatives

Candidate profile

Required education 

  • A Bachelor degree preferably in life sciences, nursing or a related field of study; Business Administration or similar expertise through experience.

Qualification and Skills

  • 2+ years of administrative management, and/or CRA (clinical research associate), CTA experience, or a history of working with histo-technology laboratories preferred
  • Strong communication skills, proficient in English language, both written and oral communications; other languages desirable
  • Proficient in Microsoft Office (Word, Excel, PowerPoint)
  • Excellent organizational skills and able to multi-task
  • Positive and energetic attitude
  • Able to take initiative, be adaptable, and strive in a dynamic environment
  • Strong attention to detail and commitment to delivering accurate results
  • Diligent and conscientious
  • Ability to work independently and as a member
  • Possesses critical thinking and problem solving skills
  • Customer and Project Manager service oriented
  • Communicate effectively with various internal stakeholders in a positive and professional manner

It's a bonus if you have: 

  • Experience in cancer research 
  • Have a working knowledge of ICH-GCP guidelines related to clinical trials
  • Worked in global locations

Offer

  • 1 year interim contract position
  • Full-time, 38 hour work week
  • CellCarta is made up of dedicated professionals who are focused on achieving our mission of impacting the future of patient therapy. We make a difference in the lives of patients around the world!
  • A competitive salary and benefits
  • A dynamic and rapidly changing global environment allowing personal growth
  • Training and personal development in a variety of areas
  • True career opportunities as the company grows
  • A healthy work life balance with on-site and remote working
  • A company that is fit for the future
  • A great team you can work with 

Contact Details

https://caprion.applytojob.com/apply/jobs/details/LMJNLBS7y0?&