Clinical Research Specialist II, Orthopedic

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

Job Description - Clinical Research Specialist II, Orthopedic (260002MN)

Clinical Research Specialist II, Orthopedic - (260002MN)

A Brief Overview

Works with the Principal Investigator to coordinate all aspects of implementation of assigned multiple and/or complex clinical research trials.

What You Will Do

• Responsible for submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files. (10%; Competency 1, 2)
• Performs all activities related to clinical research studies including but not limited to: screening participants for eligibility and recruitment, obtains informed consent, educates participants regarding study requirements and completes case report forms (CRF). (20%; Competency 1, 2)
• Responsible for in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) guidelines. (10%; Competency 1, 2)
• Documents, records and assimilates accurate participant records and study records to ensure documentation compliance with sponsor guidelines, standard operating procedures (SOP) and internal and external regulatory agencies. (20%; Competency 1, 2)
• Assists with SOP, grant and protocol development and active participant in preparation of manuscripts and presentations for scientific meetings. (10%; Competency 2,3)
• Establish and maintain communications with Investigator, Sponsor and internal constituents. (10%; Competency 1, 2)
• Mentorship of the clinical research process to the junior clinical research staff. (10%; Competency 3)
• Performs other related duties as assigned or required. (10%; Competency 1, 2, 3)

Additional Responsibilities

• Performs other duties as assigned.
• Complies with all policies and standards.
• For specific duties and responsibilities, refer to documentation provided by the department during orientation.
• Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.

Education

• Bachelor's Degree (Required)

Work Experience

• 2+ years clinical research experience (Required) and
• Experience in a team setting (Required)

Knowledge, Skills, & Abilities

• Ability to prioritize the work of multiple projects. (Required proficiency)
• Knowledge of GCP and FDA guidelines. (Required proficiency)
• Knowledge of Electronic Data Capture Programs. (Required proficiency)
• Medical & Research Terminology. (Required proficiency)
• DOT/IATA Training (Preferred proficiency)
• Ability to train and mentor junior staff. (Required proficiency)
• Detail-oriented person with the ability to collect, compile, and analyze information. (Required proficiency)
• Ability to understand and communicate research protocol requirements to others. Able to work independently on multiple tasks and manage time effectively. (Required proficiency)
• Demonstrates customer service excellence with internal and external customers (Required proficiency)
• Excellent verbal, written, interpersonal and communication skills. (Required proficiency)
• Computer skills (Outlook, Excel, PowerPoint, Word). (Required proficiency)

Licenses and Certifications

• Certification in Human Subjects Protection (CITI) (Required within 30 Days)
• Society of Clinical Research Associates (SoCRA) (Preferred) or
• ACRP Certified Professional (ACRP-CP) (Preferred)

Physical Demands

• Standing Frequently
• Walking Frequently
• Sitting Rarely
• Lifting Frequently up to 50 lbs
• Carrying Frequently up to 50 lbs
• Pushing Frequently up to 50 lbs
• Pulling Frequently up to 50 lbs
• Climbing Occasionally up to 50 lbs
• Balancing Occasionally
• Stooping Frequently
• Kneeling Frequently
• Crouching Frequently
• Crawling Occasionally
• Reaching Frequently
• Handling Frequently
• Grasping Frequently
• Feeling Constantly
• Talking Constantly
• Hearing Constantly
• Repetitive Motions Constantly
• Eye/Hand/Foot Coordination Constantly

Travel Requirements

• 10% Travel may be required