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Job description
* Develop and execute a multi-year clinical research strategy aligned with organizational objectives.
* Establish annual research goals, performance metrics, and growth initiatives.
* Identify emerging trends and opportunities within spine surgery, orthopedic surgery, biologics, robotics, navigation technologies, and medical devices.
* Build and maintain strategic partnerships with academic centers, industry sponsors, CROs, and key opinion leaders.
* Lead efforts to expand the organization's research portfolio and clinical trial pipeline.
* Direct all phases of clinical research studies, including feasibility assessments, protocol implementation, patient recruitment, data collection, monitoring, and study closeout.
* Oversee a portfolio of industry-sponsored, investigator-initiated, and multicenter clinical studies.
* Ensure research projects are completed on time, within budget, and according to protocol requirements.
* Develop and implement SOPs to improve efficiency, quality, and compliance.
* Monitor study enrollment, retention, and performance metrics.
* Ensure compliance with FDA regulations, Good Clinical Practice (GCP), HIPAA, IRB requirements, and applicable federal, state, and institutional guidelines.
* Maintain readiness for sponsor audits, FDA inspections, and regulatory reviews.
* Oversee adverse event reporting, protocol deviations, and corrective action plans.
* Establish quality assurance and quality improvement initiatives for research operations.
* Collaborate with spine and orthopedic surgeons to identify clinically relevant research opportunities.
* Provide guidance on study design, protocol development, statistical methodologies, and publication strategies.
* Support manuscript preparation, abstracts, presentations, and peer-reviewed publications.
* Promote dissemination of research findings at national and international scientific meetings.
* Foster a culture of inquiry, innovation, and evidence-based practice.
* Develop and manage departmental budgets, research revenue forecasts, and study-related financial plans.
* Lead sponsor contract negotiations and clinical trial budgeting activities.
* Ensure accurate financial tracking, invoicing, and reimbursement for research activities.
* Identify funding opportunities through grants, foundations, and industry partnerships.
* Recruit, mentor, and develop research coordinators, managers, data specialists, and research staff.
* Establish performance objectives and professional development plans.
* Foster a collaborative and high-performing research environment.
* Serve as a trusted advisor to physicians, executives, and operational leaders.
Qualifications
* Master's degree in Clinical Research, Public Health, Healthcare Administration, Life Sciences, Nursing, or related field.
* Advanced degree (PhD, MD, DO, PharmD, or equivalent) preferred.
* 10+ years of progressive clinical research experience.
* 5+ years of leadership experience managing clinical research programs and teams.
* Significant experience in spine surgery, orthopedic surgery, musculoskeletal medicine, medical devices, or related clinical specialties.
* Demonstrated success managing industry-sponsored and investigator-initiated studies.
* Experience with multicenter clinical trials and registry-based research.
* Certified Clinical Research Professional (CCRP)
* Certified Clinical Research Coordinator (CCRC)
* Clinical Research Associate Certification (CCRA)
* Good Clinical Practice (GCP) Training
* Deep understanding of orthopedic and spine surgery procedures, technologies, implants, and outcomes research.
* Advanced knowledge of FDA regulations, IRB processes, GCP standards, and human subject protections.
* Strong clinical trial design, biostatistics, and scientific writing capabilities.
* Proven ability to develop high-performing research teams.
* Excellent project management and organizational skills.
* Strong financial acumen related to clinical trial budgeting and contract negotiations.
* Exceptional communication and stakeholder management skills.
* Proficiency with electronic data capture systems, CTMS platforms, REDCap, and statistical software.
Preferred Qualifications
* Spine implants and instrumentation
* Orthopedic trauma, sports medicine, joint reconstruction, or deformity correction
* Robotic-assisted spine or orthopedic surgery
* Medical device clinical trials
* FDA IDE and post-market surveillance studies
* Outcomes research and patient-reported outcome measures (PROMs)
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Worksite address
california, MO, 65018, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.