Clinical Research Procedures & Documentation Specialist

Kelly Science and Clinical FSP is currently seeking a Clinical Research Procedures and Documentation Specialist for a long-term engagement with one of our Global Medical Device clients. 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.

Clinical Research Procedures & Documentation Specialist
Position Summary
The Clinical Research Procedures & Documentation Specialist will be responsible for developing, drafting, revising, and maintaining clinical operations processes and procedures related to the execution of clinical studies for medical devices. The ideal candidate will have a background in clinical operations, procedure documentation, and process improvement within the medical device sector—preferably orthopaedics, though candidates with broader medical device experience will be considered. This individual will collaborate closely with clinical research, clinical operations, biostatistics, and data management teams, acting as a liaison to gather requirements and feedback from subject matter experts (SMEs), and ensuring that all clinical procedures are clear, compliant, and reflect current best practices.
Primary Responsibilities

• Collaborate with cross-functional teams (Clinical Research, Operations, Biostats, Data Management) and subject matter experts to collect feedback on clinical operations processes and procedures.
• Draft, redline, and revise standard operating procedures (SOPs), work instructions, and process documents related to clinical study execution for medical devices.
• Incorporate multidisciplinary feedback, resolve comments, and route revised documents for appropriate review and electronic approval in relevant document management systems.
• Assist with the development and optimization of documentation templates to ensure clarity, consistency, and compliance with global medical device regulatory requirements.
• Ensure all clinical research and study execution documentation aligns with applicable Good Clinical Practice (GCP), FDA, and EU MDR requirements.
• Lead cross functional teams to evaluate process improvements by identifying gaps and proposing enhancements to procedures for clinical study planning, execution, oversight, and data management.
• Provide training or guidance on updated procedures and documentation to relevant staff.
• Support project management activities to ensure document deliverables are completed on time, including timeline development, meeting planning, milestone tracking, and stakeholder communications.
• Maintain organized records of all procedure versions, approvals, and feedback, ensuring audit readiness.

Qualifications

• Bachelor’s degree in Biological/Biomedical Science, Life Sciences, or a related discipline.
• Minimum 4 years of experience in clinical research or clinical operations in the medical device industry (orthopaedic device experience preferred; other device backgrounds considered).
• Demonstrated experience drafting, maintaining, and implementing clinical study processes and procedures.
• Experience implementing process improvement initiatives within clinical research or operations.
• Advanced technical/medical writing and strong documentation skills.
• Familiarity with clinical documentation requirements for FDA and EU Medical Device Regulation (MDR).
• Strong project management and organizational skills; able to develop and manage timelines, coordinate meetings, and track progress against goals.
• Excellent written and verbal communication skills; able to work collaboratively with diverse teams.
• Proficient in Microsoft Office Suite, including Excel and SharePoint.
• Understanding of Good Clinical Practices and medical device regulatory requirements pertaining to clinical research.
• Experience with document management systems is desirable.

• Experience implementing process improvement initiatives within clinical research or operations.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.

As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.