Clinical Research Assistant

McLaren Health Care•Mount Clemens, MI

About The Position

The Clinical Research Assistant provides support to a clinical research coordinator or clinical research nurse. The role includes administrative assistance, organization and maintenance of research materials, data entry, and support for documenting study requirements in accordance with protocol guidelines and applicable internal and external regulations. The assistant updates the Clinical Trials Management System (CTMS), obtains required signatures on clinical trial documents, and returns documents within specified time frames. The role also involves responding to customer requests, assisting with sponsor visits, and performing data quality checks. The employee receives supportive mentoring for skills development after orientation. Assignments are set by a supervisor according to skills, training, and competence, and may increase in complexity and self-direction as experience grows.

Requirements

  • High school diploma.

Nice To Haves

  • Six months of experience with data entry.
  • Office experience in a medical setting.

Responsibilities

  • Provide general administrative assistance, including support for organizational processes, materials management, and data entry.
  • Maintain files, logs, and other materials in an organized and efficient manner.
  • Assist clinical research staff in documenting study requirements in accordance with protocol guidelines and internal and external regulations.
  • Update the Clinical Trials Management System (CTMS).
  • Obtain required signatures on clinical trial documents and return documents within specified time frames.
  • Respond to internal and external customer requests in a timely fashion.
  • Assist with the coordination of sponsor visits.
  • Perform data quality checks as needed.
  • Perform other related duties as required and directed.
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