Associate Clinical Research Contracts Specialist

Kelly Science and Clinical FSP is currently seeking an Associate Clinical Research Contracts Specialist for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical clients. This position is hybrid. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. 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. Associate Clinical Research Contracts Specialist ESSENTIAL DUTIES AND RESPONSIBILITIES

Under General Direction Of Clinical Research Management, And In Accordance With All Applicable Regional, State And Local Laws/regulations And Corporate Client Procedures And Guidelines, This Position Will

• Initiate agreement requests per company SOPs and legal requirements.
• Manage the end-to-end contracting process for agreements including, but not limited to, NDA, consulting, and vendor agreements.
• Serve as the primary point of contact between Clinical Research, Legal, HCC/Compliance, Privacy, and external parties
• Track agreement status, approvals, and execution timelines to ensure alignment with study milestones
• Ensure all agreements are fully executed prior to engagement or information exchange
• Maintain accurate and audit?ready records of executed agreements and related documentation
• Support fair market value (FMV) confirmation and documentation, as applicable
• Communicate agreement status and timelines to study teams and stakeholders
• Participate in inspection readiness activities by providing agreement documentation as requested
• Actively participate in study team meetings and project updates.
• May assist in processing consulting/HCP payments
• May participate in process improvement activities within the department.
• May perform other related duties assigned as needed.
• Responsible for communicating business-related issues or opportunities to next management level.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  
  

REQUIRED EDUCATION/TRAINING And/or EXPERIENCE

• Bachelor’s Degree or higher with 0-4 years of work-related experience
• Prefer a degree in the sciences
• Prefer knowledge of clinical research
• Prefer medical device experience in the cardiovascular field
  
  

REQUIRED KNOWLEDGE, SKILLS, ABILITIES And CERTIFICATIONS/LICENSES

• Ability to use PC and associated software.
• Excellent PowerPoint, Word, Excel skills.
• Excellent written and oral communications skills.
• Ability to multi-task, excellent attention to detail, and organizational skills.
• Working knowledge of Good Clinical Practices (GCP) is desirable.
• Knowledge of project management tools is desirable.
  
  

Posted By: Karli Minor