Clinical Trial Associate

Shoulder Innovations•Grand Rapids, MI

2d•$60,000 - $70,000

About The Position

Shoulder Innovations is a medical device startup developing shoulder replacement systems. The Clinical Trial Associate provides 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 associate communicates with Principal Investigators and research staff, supports site onboarding, participates in data monitoring, and performs other duties at the direction of the Associate Director of Clinical Affairs. The position supports clinical trial documentation, regulatory submissions, protocol compliance, trial operations, data handling, performance tracking, and communications with study sites and stakeholders. The associate also contributes to cross-functional study operations and completes additional tasks as assigned. Shoulder Innovations states that it offers opportunities for professional growth, competitive wages, and benefits within a supportive company culture.

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 are 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 Good Clinical Practice (GCP) standards.
Assist with preparing, reviewing, and submitting Institutional Review Board (IRB) documents.
Monitor adherence to study protocols and regulatory guidelines, identify compliance gaps, and help address them.
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, respond to inquiries, provide updates, and disseminate information to stakeholders.
Perform additional tasks assigned by the Associate Director of Clinical Affairs.
Support site onboarding, participate in data monitoring, and communicate with Principal Investigators and research staff.