Clinical Trial Operations Specialist

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 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.