Job Title: Clinical Research Assistant
Location: San Diego, CA
Duration: 12 Months
 
Responsibilities:
Clinical Study Coordination & Execution

• Coordinate end-to-end clinical study activities including subject scheduling, informed consent, visit execution, and device insertions/removals
• Serve as the primary point of contact during study sessions to ensure
• protocol adherence, subject safety, and data quality
• Manage visit flow, staffing, and real-time issue resolution during active study conduct

Protocol Review & Development

• Review clinical protocols for feasibility, operational impact, and compliance with regulatory and internal requirements
• Draft and revise protocol language, study procedures, and supporting documentation in collaboration with cross-functional partners
• Provide operational input to improve clarity, efficiency, and execution readiness

IRB Submissions & Regulatory Support

• Prepare, submit, and manage IRB applications, amendments, continuing reviews, and study close-out documentation
• Ensure timely responses to IRB queries and maintain compliance with regulatory timelines and requirements
• Track approvals and coordinate regulatory readiness prior to study initiation

Job Aid & Process Documentation

• Draft, review, and maintain job aids, SOP-adjacent tools, and training materials to support consistent study execution
• Translate complex study procedures into clear, user-friendly guidance for clinical staff
• Update documentation based on protocol changes, process improvements, and study learnings

Program & Study Session Management

• Provide program management support for individual study sessions, including planning, execution tracking, and post-session follow-up
• Coordinate cross-functional stakeholders to ensure alignment on timelines, roles, and deliverables
• Monitor session-level risks and proactively implement mitigation strategies

Global Collaboration & Enablement

• Partner with global and regional teams to support onboarding, training, and study completion activities
• Ensure alignment across time zones and regions for study readiness, execution, and close-out tasks
• Facilitate knowledge transfer and consistency in processes across global study teams

Continuous Improvement & Lessons Learned

• Compile, document, and analyze lessons learned from completed studies and study sessions
• Identify opportunities to improve efficiency, quality, and scalability of clinical operations
• Drive process enhancements and best practices to optimize future study execution

 
Required Experience

• 2-3 Years coordinating/ CRA

 
Required Skills (top 3 non-negotiables)

• Face to face study coordination tasks
• IRB Submissions/navigations
• Program management

 
Preferred Skills

• Medical background
• Medical device experience (GCMs)
• Protocol curating

 
Education Requirements: Bachelor in Science
Software Skills Required: EDC systems, CTMS systems
Required Certifications: GCP, AED (preferred)
 
  
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 40.00/hr.