Clinical Trial Associate

Shoulder Innovations LLC; Grand Rapids (MI); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Great company culture

Professional growth opportunities

Competitive wages

Benefits

Job summary

Shoulder Innovations is a medical device startup focused on innovative shoulder replacements. We seek a Clinical Trial Associate to support trial operations, regulatory compliance, and documentation under the guidance of the Associate Director of Clinical Affairs.

The role involves TMF management, IRB document handling, cross-functional team coordination, data tracking, and site communications to ensure timely and compliant study progress.

Qualifications

• Bachelor's degree or equivalent combination of education and training.
• 2+ years experience at Sponsor or CRO level, or 5 years at SMO/site level.
• Experience with medical device clinical studies preferred.
• Experience with shoulder arthroplasty or orthopedics is a benefit but not essential.
• Familiarity with clinical development standards and regulatory requirements (GCP, FDA).
• Knowledge of industry standards (GCP, ICH, CDISC/CDASH).
• Proficiency with Microsoft Office (Excel, Word); strong Excel skills.
• Experience working in cross-functional, multi-site clinical trial teams.

Responsibilities

• Provide comprehensive administrative support for clinical trial operations and TMF documents.
• Oversee documentation processes to meet GCP standards and regulatory requirements.
• Assist in preparing and submitting IRB documents and approvals.
• Monitor adherence to study protocols and regulatory guidelines.
• Support day-to-day trial operations with cross-functional teams.
• Track and manage study data, including CRF handling and data entry.
• Monitor trial progress, draft status reports, and escalate issues as needed.
• Coordinate site communications and disseminate information to stakeholders.
• Perform additional tasks as assigned by the Associate Director of Clinical Affairs.

Skills

GCP knowledge

FDA regulations

MS Excel

Cross-functional teams

Data management

Education

Bachelor's degree

Tools

Microsoft Office

Job description

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. This position will communicate with Principal Investigators and/or their research staff, support onboarding sites to the clinical study, participate in data monitoring and other tasks at the direction of the Associate Director of Clinical Affairs.

Your responsibilities will include, but are not limited to the following:

• 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.
• Perform additional tasks and responsibilities as assigned by the Associate Director of Clinical Affairs, contributing to the overall success of the study and supporting team objectives.

We believe to be successful as a Clinical Trial Associate, you will have the following:

• 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

We value and appreciate our employees and will support you with great company culture, opportunities for professional growth, competitive wages, and benefits. To learn more about us, visit us online at https://shoulderinnovations.com.