Clinical Trial Associate

Shoulder Innovations•Grand Rapids, MI

About The Position

Shoulder Innovations is a medical device startup that is revolutionizing shoulder replacements. Led by a seasoned team with over a century of orthopedic expertise, we’ve developed a disruptive shoulder replacement system and secured substantial funding to drive rapid growth. (NYSE: SI) . We’re seeking entrepreneurial talent to join us on this exciting journey. Our culture is built on: People First : Authentically human. One Team : Empowered and aligned. Innovation : Bold, creative, and daring. Growth Mindset : Always curious. Ready to make an impact in orthopedics? Let’s grow together! We are seeking a Clinical Trial Associate who is responsible for administrative and other support related duties for clinical studies conducted by Shoulder Innovations . This position requires a good understanding of clinical study processes and regulatory standards such as Good Clinical Practice (GCP) and FDA regulations. In addition , your responsibilities wi ll include, but are not limited to the following:

Requirements

Bachelor’s degree or an equivalent combination of experience , education and training considered
2+ years’ experience at the Sponsor or CRO level, or 5 years at the SMO or site level
Familiarity with clinical development standards and regulatory requirements (GCP, FDA)
Excellent communication, organization, and problem-solving skills
Detail-oriented and dependable, with the ability to manage multiple priorities under tight deadlines
Excellent analytical and problem-solving skills
Proficient written and verbal communication skills
Solid organizational and time management skills
Ability to be independently motivated

Nice To Haves

Experience with medical device clinical studies preferred
Experience with shoulder arthroplasty or orthopedics is a benefit but not essential

Responsibilities

Provide comprehensive administrative support for clinical trial operations, including organizing, maintaining, and updating study documentation to ensure accuracy and completeness within the Trial Master File (TMF)
Manage and oversee documentation processes, ensuring all regulatory and compliance requirements are met and that files adhere to Good Clinical Practice (GCP) standards
Assist in the 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 to maintain the integrity of the trial
Support day-to-day trial operations, collaborating with cross-functional teams to resolve operational issues and maintain smooth study progress
Track and manage study data, including accurate handling of Case Report Forms (CRFs), ensuring data integrity and timely entry into relevant systems
Monitor trial progress and performance metrics, maintaining effective communication with study sites, drafting detailed status reports, and escalating issues as needed
Coordinate site communications, serving as a point of contact for inquiries and updates, and ensuring timely dissemination of information to stakeholders