Clinical Operations Project Coordinator

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

The hourly rate range for this position is $29.73 - $39.16. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate’s work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.

Minimum Education: Bachelor's degree in related field(s) Addtional Education Requirements Combined experience/education as substitute for minimum education Minimum Experience: 2 years in on-site clinical trial monitoring. Minimum Skills: Industry experience in a pharmaceutical, biotechnology, clinical research organization and/or nursing setting. 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. Preferred Education: Bachelor's degree And Master's degree In Neurosciences Or Public Health Or Pharmacology Or in related field(s) Preferred Certifications: Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC). Preferred Experience: 4 years Preferred Skills: Experience in data management. Excellent written and verbal communication skills to express complex ideas to study staff at research and clinical institutions. Excellent organizational skills, and ability to interact with all levels of staff to coordinate and execute study activities. Ability to handle several priorities within multiple, complex clinical trials. An understanding of current GCP guidelines applicable to the clinical research conduct. Proficient in OmniPlan or other timeline applications. Familiarity with academic medical centers.