Clinical Trial Associate

Shoulder Innovations•Grand Rapids, MI

About The Position

Shoulder Innovations is seeking a Clinical Trial Associate to provide administrative and operational support for the company’s clinical studies. The role requires an understanding of clinical study processes and regulatory standards, including Good Clinical Practice (GCP) and FDA regulations. The Clinical Trial Associate communicates with Principal Investigators and research staff, supports site onboarding, participates in data monitoring, and performs other duties under the direction of the Associate Director of Clinical Affairs. The position supports clinical trial documentation, regulatory compliance, IRB submissions, study data management, site communications, and day-to-day trial operations. It works with cross-functional teams and study sites to help maintain study progress, data integrity, and compliance with protocols and applicable standards. The company offers competitive wages, benefits, a supportive company culture, and opportunities for professional growth.

Requirements

Bachelor’s degree, or an equivalent combination of experience, education, and training.
At least 2 years of experience at the Sponsor or CRO level, or 5 years at the SMO or site level.
Familiarity with clinical development standards and regulatory requirements, including GCP and FDA regulations.
Knowledge of current industry standards, such as GCP, ICH, and CDISC/CDASH.
Proficiency with Microsoft Office, including Excel and Word; strong Excel skills required.
Experience working in cross-functional, multi-site clinical trial teams.

Nice To Haves

Experience with medical device clinical studies is preferred.
Experience with shoulder arthroplasty or orthopedics is beneficial but not essential.

Responsibilities

Provide administrative support for clinical trial operations, including organizing, maintaining, and updating study documentation in the Trial Master File (TMF).
Manage documentation processes to meet regulatory and compliance requirements and GCP standards.
Assist with preparing, reviewing, and submitting Institutional Review Board (IRB) documents.
Monitor adherence to study protocols and regulatory guidelines, 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 handling Case Report Forms (CRFs) and ensuring accurate, timely data entry.
Monitor trial progress and performance metrics; communicate with study sites, draft status reports, and escalate issues as needed.
Coordinate site communications and respond to inquiries and updates, ensuring timely information-sharing with stakeholders.
Perform additional tasks assigned by the Associate Director of Clinical Affairs.