Clinical Research Procedures & Documentation Specialist

Clinical Research Procedures & Documentation Specialist

Medical Device – Orthopedics Required
Contract Role Through End of 2026 (Potential Extension)

Position Overview

We are seeking an experienced Clinical Research Procedures & Documentation Specialist with direct experience supporting orthopedic medical device clinical trials.

This role is focused on clinical study execution processes, SOP development, and work instruction writing within orthopedic device studies. The selected candidate will work closely with Clinical Operations, Biostatistics, and Data Management teams to revise and harmonize clinical procedures to reflect real-world orthopedic study execution workflows.

This is not a medical writing role (CER/PMCF/PMS).

Key Responsibilities

• Collaborate with Clinical Operations SMEs to review and update clinical research procedures specific to orthopedic device studies
• Draft, redline, and finalize SOPs and work instructions that govern study execution activities
• Ensure procedures align with actual orthopedic trial workflows (site start-up, enrollment, device accountability, monitoring, close-out)
• Facilitate cross-functional discussions to gather feedback and drive alignment
• Develop and manage project timelines to keep procedural updates on track
• Route finalized documents through appropriate document management and approval systems
• Support inspection readiness and ensure compliance with FDA, ICH-GCP, and applicable medical device regulations
• Contribute to procedural harmonization initiatives related to organizational changes

Required Qualifications

• Minimum 5+ years of experience in clinical research within the medical device industry
• Direct experience supporting or managing orthopedic device clinical trials
• Demonstrated experience drafting or revising:
• Clinical Operations SOPs
• Work Instructions
• Study execution processes
• Strong understanding of the orthopedic device study lifecycle (start-up through close-out)
• Experience working cross-functionally with Clinical Operations teams
• Experience using document management systems and routing documents for approval
• Strong organizational and project coordination skills

Preferred Qualifications

• Experience with joint replacement, spine, trauma, or sports medicine device trials
• Experience supporting audit and inspection readiness
• Familiarity with FDA and MDR requirements for orthopedic devices
• Experience in change management or procedural harmonization initiatives

This Role Is Not:

• Not a CER / PMCF / PMS medical writing role
• Not a site-only CRC position
• Not a pharmacovigilance-only position

Job Type: Contract

Pay: $34.39 - $41.41 per hour

Expected hours: 40 per week

Work Location: Remote