Operations Coordinator

Operations Coordinator

Kelly Science and Clinical FSP is seeking an Operations Coordinator for a long-term engagement in Irvine, CA. This position is hybrid. The role is full-time with benefit options through Kelly FSP, a managed solution provider and business unit of Kelly Services, Inc. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from.

You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

Performs a variety of activities within the Clinical Sciences department in support of various clinical trials and projects. To be successful in this role an individual must manage the details of contracts and sponsor ships and liaise with stakeholders in the Professional Education and Marketing departments to coordinate contract specifics and identify materials for sponsorship deliverables.

• Education: Bachelor’s degree or higher from an accredited institution; preferred degree in the sciences.
• Computer
  
  Skills:
  
  Microsoft Office products – Word, Excel, PowerPoint, Project, and SharePoint.
• Regulatory Knowledge: Knowledge of FDA guidelines, regulations and/or Good Clinical Practice.
• Communication: Good communication via written, verbal and listening skills; ability to understand written work instructions and follow the requirements.
• Soft Skills: Strong organizational skills; ability to work with minimal supervision in a team environment.
• Preferences: Prefer a degree in the sciences.
• Prefer knowledge of clinical research.
• Prefer medical device experience.

• Clinical Department Support: Contract requests and due diligence.
• Periodic meeting scheduling/support.
• Document support.
• Study Development: Support the development of clinical studies working directly with study teams.
• Meeting Coordination: Assists with scheduling and organizing meetings, as requested; actively participate in study team meetings and project updates.
• Cross-Functional Collaboration: Works with internal cross-functional representatives and external partners to meet Clinical Sciences department needs.
• Contract Processing: Prepare and process contracts and sponsor ships for team.
• Documentation Management: Provides general documentation support to project teams (Formatting, tracking, finalizing protocols, literature reviews, and other necessary study/project documentation).
• Compliance: Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

• Gives no supervision to others.
• Under general or minimum supervision, performs duties in terms of stated objectives.
• Generally works out details within broad guidelines and exercises considerable initiative and judgment.