Clinical Trial Associate

Shoulder Innovations

. Provide comprehensive administrative support for clinical trial operations, including organizing, maintaining, and updating study documentation within the Trial Master File (TMF) .

Posted 10/23/2026full-timeRemote • Michigan • United StatesJuniorMid-Level💰 $60,000 - $70,000 per yearWebsite

About the role

Key responsibilities & impact

Provide comprehensive administrative support for clinical trial operations, including organizing, maintaining, and updating study documentation within the Trial Master File (TMF)
Manage documentation processes to meet regulatory and compliance requirements and Good Clinical Practice (GCP) standards
Assist with preparation, review, and submission of 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 Case Report Forms (CRFs), ensuring data integrity and timely system entry
Monitor trial progress and performance metrics, communicate with study sites, draft status reports, and escalate issues
Coordinate site communications and serve as a point of contact for inquiries and updates
Perform additional tasks assigned by the Associate Director of Clinical Affairs

Requirements

What you’ll need

Bachelor's degree, or an 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 a benefit but not essential
Familiarity with clinical development standards and regulatory requirements (GCP, FDA)
Knowledge of current industry standards (e.g., GCP, ICH, CDISC/CDASH)
Proficiency with Microsoft Office (Excel, Word); strong Excel skills required
Experience working in cross-functional, multi-site clinical trial teams

Benefits

Comp & perks

Great company culture
Opportunities for professional growth
Competitive wages
Benefits