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Clinical Operations Project Coordinator

USC Alzheimer's Therapeutic Research Institute San Diego, California

The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California, is an academic institute comprised of an expert panel of scientific collaborators, committed to advancing the development of new treatments for Alzheimer’s Disease (AD) through innovative clinical trials.

The ATRI is seeking a skilled, dependable, and detail-oriented Project Coordinator to support the ATRI Clinical Operations team in managing the implementation, maintenance and closeout of Alzheimer’s disease clinical trials at multiple national and international ATRI clinical trial study sites. 

The ATRI Project Coordinator serves a key study support role on the Clinical Operations team.  Responsibilities include, but are not limited to: 

  • Consult with the Clinical Operations Project Manager to assist study leadership in the planning and administration of all phases of multi-site clinical trials
  • Assist with setting and maintaining priorities and timelines for project completion
  • Assist with taking meeting minutes, logging action items and decisions, and tracking action items to completion
  • Participate in the development of various study materials including training and procedures manuals, source documents, and work instruction documents
  • Design and generate analytical, comparative, and tracking reports for the refinement of operational activities and aid in the strategic planning of new research initiatives
  • Executes work deliverables in a manner that is compliant with FDA regulations and ICH-CGP guidelines

The ideal candidate will have strong organizational capabilities, excellent written and oral communications skills, and demonstrated ability to work independently with minimal oversight to support research activities.  

Two to three years of experience in clinical trials is preferred but not required.

Location:  San Diego, CA

Salary is dependent on education and experience.

Minimum Education: Bachelor's Degree Combined experience/education as substitute for minimum education Minimum Experience: 2 years Minimum Field of Expertise: Bachelor’s degree in life sciences or similar field, or a combination of experience and an Associate’s degree as substitute for minimum education. Industry experience in a pharmaceutical, biotechnology, clinical research organization and/or nursing setting, with at least two or more years’ experience in on-site clinical trial monitoring. Demonstrated experience using medical devices and terminology. Experience applying policies and procedures, with some familiarity with ICH-GCP guidelines and working knowledge of HIPAA and FDA guidance documents. Skilled at technical documentation and writing, and at assembling, organizing and conceptualizing numerical data in spreadsheets, databases, reports and presentations. Lead/guidance skills, with the ability to manage and prioritize different tasks and projects. Deft interpersonal skills for communicating with all levels of staff and diverse individuals and groups coordinating and executing study activities.

REQ20093351 Posted Date: 09/22/2020 - Thru date - 2020-12-31

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