Clinical Study Associate

1 month ago

Oro Valley, United States Compass Consulting Full time
Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies.

Overview:

As a Clinical Study Associate (CSA) you are part of the Clinical Services Management team and will support the Clinical Services Project Management Team through a varying packet of tasks linked to Sponsors Monitoring Visits (Study/site Qualification and Initiation Visits, Monitoring Visits, Closure Visits, Ad hoc Visits, Monitoring Ad Hoc requests), and/or Pharma Partners audit. Your day will be filled with on site administrative tasks to always keep the Sponsors monitoring visits (before, during and after visits) and /or Pharma Partners audit requests on Task, on Track and on Time.

Roles & Responsibilities:
  • The CSA is responsible for the delivery of specific tasks, generally overseen by the study Project and/or Program Managers. The specific tasks are time sensitive and will be followed up accordingly.
  • The CSA ensures that the activities and tasks are accomplished within the CDx CAP/CLIA Laboratory quality system.
  • Work closely with Quality, CDx CAP/CLIA Laboratory, and Pathologist.
  • Calendar Management: Coordinates with applicable functions times for SIV, Monitoring Visits, Closing Visits, and/or Audits times.
  • Laboratory and/or Study Document Maintenance and Preparation for Auditors: Ensures Delegation of Authority (DOA) Logs are up to date, applicable personnel listed on DOA has applicable trainings completed, device accountability logs are completed on time, good documentation practices (GDP) is performed by laboratory personnel in paper documentation, device registration study binders are up to date and completed as per study requirements.
  • Work closely with Lab Manager and/or representative to ensure documentation is provided on time (e.g. get from Lab instruments maintenance records, logs, etc) and new personnel are up to date on DOAs.
  • Facilitate and/or attend Monitoring visits activities.
  • Supplier Questionnaire Document Management: Complete supplier questionnaire using already captured information, ensures follow up with applicable functions Subject Matter Experts to complete documents on time.
  • Maintain and manage questionnaires dates and document maintenance.
  • Participate in process improvement initiatives.

Education:
  • 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 entry level CRA (clinical research associate), CTA experience, or a history of working with histo-technology laboratories preferred but not required.
  • Strong communication skills, proficient in English language, both written and oral communications; other languages desirable.
  • Proficient in Microsoft Office (Word, Excel, PowerPoint) and Google Tools.
  • Excellent organizational skills and able to multi-task • Positive and energetic attitude.
  • Able to take initiative, be adaptable, and strive in a dynamic environment.
  • Customer and Project Manager service oriented.
  • Communicate effectively with various internal stakeholders in a positive and professional manner.
  • t's a bonus if you have: Experience in cancer research and/or have a working knowledge of ICH-GCP guidelines related to clinical trials.

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