Employer Industry: Medical Device Manufacturing

Why consider this job opportunity:
- Opportunity for career advancement and growth within the organization
- Supportive and collaborative work environment
- Chance to make a positive impact on patient outcomes in the field of orthopedic surgery
- Competitive pay and benefits package
- Flexibility to travel as needed for site visits and clinical trials

What to Expect (Job Responsibilities):
- Oversee clinical trial activities at investigational sites, ensuring compliance with study protocols and regulations
- Conduct remote and in-person site visits for qualification, initiation, monitoring, and close-out of clinical studies
- Generate high-quality reports for site visits in accordance with the Clinical Monitoring Plan
- Contribute to the development of study protocols, informed consent forms, and clinical study reports
- Ensure the protection of human subjects and maintain data quality by reviewing adverse events and implementing corrective actions

What is Required (Qualifications):
- Minimum of 5 years of experience in clinical research, specifically in medical device trials and orthopedics
- Working knowledge of Good Clinical Practices (GCPs), FDA regulations, and IRB requirements
- Strong project management skills with attention to detail and reliability
- Proficiency in Microsoft Office Suite and experience with electronic data capture (EDC) and electronic Trial Master File (eTMF) systems
- Ability and willingness to travel up to 50%

How to Stand Out (Preferred Qualifications):
- SUCRA/ACRP Certification
- Bachelor’s degree in a science or related field
- Familiarity with medical and anatomical terminology
- Experience interfacing with physicians and clinical staff in hospital environments

#MedicalDevices #ClinicalResearch #Orthopedics #CareerOpportunity #ProjectManagement

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