Orthopedic Clinical Research Specialist II

University Hospitals; Cleveland (OH); On-site; USD 65,000 - 90,000; Full time

Job summary

University Hospitals in Cleveland, OH seeks a Clinical Research Specialist II for Orthopedic trials. You will coordinate trial activities, manage regulatory submissions, and ensure GCP compliance while supporting protocol development and manuscript preparation.

The role requires 2+ years of clinical research experience and a Bachelor’s degree. Strong teamwork, mentoring, and communication skills are essential for success in a busy, multi-site environment.

Qualifications

• Bachelor's degree required.
• 2+ years clinical research experience required.
• Experience working in a team setting required.
• Knowledge of GCP and FDA guidelines required.
• Familiarity with Electronic Data Capture (EDC) systems essential.
• Able to train and mentor junior staff.

Responsibilities

• Coordinate implementation of complex clinical trials with the Principal Investigator.
• Submit regulatory documents and maintain regulatory files.
• Screen participants, obtain informed consent, educate participants, and complete CRFs.
• Maintain protocol and GCP knowledge; ensure compliance with sponsor SOPs.
• Assist with SOP/grant/protocol development and manuscript preparation.
• Establish and maintain communications with investigators, sponsors and internal teams.
• Mentor junior staff in the clinical research process.
• Perform other duties and ensure PHI safety and compliance.

Skills

GCP knowledge

FDA guidelines

EDC programs

Medical terminology

Mentor junior staff

Time management

Communication skills

MS Office

DOT/IATA training

Education

Bachelor's Degree

Tools

Outlook

Excel

PowerPoint

Word

Job description

University Hospitals in Cleveland, OH seeks a Clinical Research Specialist II for Orthopedic trials. You will coordinate trial activities, manage regulatory submissions, and ensure GCP compliance while supporting protocol development and manuscript preparation.

The role requires 2+ years of clinical research experience and a Bachelor’s degree. Strong teamwork, mentoring, and communication skills are essential for success in a busy, multi-site environment.