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Shoulder Innovations is a medical device startup revolutionizing shoulder replacements with a disruptive shoulder replacement system. The company is led by a seasoned team with over a century of orthopedic expertise and has secured substantial funding to drive rapid growth (NYSE: SI).
The Clinical Trial Associate will provide comprehensive administrative and operational support for clinical studies conducted by Shoulder Innovations. This role requires a solid understanding of clinical study processes and regulatory standards including Good Clinical Practice (GCP) and FDA regulations. The associate will communicate with Principal Investigators and their research staff, support site onboarding, participate in data monitoring, and execute tasks under the direction of the Associate Director of Clinical Affairs.
Key responsibilities include:
- Provide comprehensive administrative support for clinical trial operations, organizing and maintaining study documentation to ensure accuracy and completeness within the Trial Master File (TMF)
- Manage documentation processes, ensuring all regulatory and compliance requirements are met and files adhere to GCP standards
- Assist in preparation, review, and submission of Institutional Review Board (IRB) documents, ensuring timely approvals and compliance with ethical standards
- Monitor adherence to study protocols and regulatory guidelines, proactively identifying and addressing compliance gaps
- Support day-to-day trial operations and collaborate with cross-functional teams to resolve operational issues
- Track and manage study data, including accurate handling of Case Report Forms (CRFs) and timely data entry
- Monitor trial progress and performance metrics, maintain effective communication with study sites, draft status reports, and escalate issues as needed
- Coordinate site communications, serve as a point of contact for inquiries and updates, and ensure timely information dissemination to stakeholders
- Perform additional tasks as assigned by the Associate Director of Clinical Affairs
The company culture emphasizes People First (authentically human), One Team (empowered and aligned), Innovation (bold, creative, and daring), and Growth Mindset (always curious). The role offers opportunities for professional growth in a pioneering and evolving industry.
REQUIREMENTS:
- Bachelor's degree or equivalent combination of experience, education, and training
- 2+ years experience at the Sponsor or CRO level, OR 5 years at the SMO or site level
- Experience with medical device clinical studies preferred
- Experience with shoulder arthroplasty or orthopedics beneficial but not essential
- Familiarity with clinical development standards and regulatory requirements (GCP, FDA)
- Knowledge of current industry standards (GCP, ICH, CDISC/CDASH)
- Proficiency with Microsoft Office (Excel, Word); strong Excel skills required
- Experience working in cross-functional, multi-site clinical trial teams
