Clinical research specialist vs quality specialist

Differences between clinical research specialist and quality specialist duties and responsibilities

Clinical research specialist example responsibilities.

• Manage the input of the subjects' data among various management database including iMedidata, EDC.
• Develop and project manage a staffing program model to support inpatient oncology.
• Manage all planning and execution of oncology clinical trials, domestic and international, including decision impact and companion diagnostic trials.
• Review and edit clinical documentation for FDA submission and approval.
• Prepare investigator initiate and industry study protocol for IRB review and approval.
• Participate in study developments to ensure compliance with FDA regulations and guidelines.
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Quality specialist example responsibilities.

• Manage CMOs that provide Endo with API, bulk, packaging services, and/or finish goods, including clinical material.
• Manage PPAP sample dimensional verification activities.
• Recommend changes to organizational committee structure to achieve higher level of accountability and oversight.
• Manage document control including initiating and revising procedures, QA approval and implementation of documents.
• Manage performance improvement and quality improvement projects design to assess and improve health outcomes for Medicaid members.
• Manage hospital core measures abstraction, registry abstractions and review services to assist healthcare organizations in improving performance.
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