Job Description

Clinical Trials Regulatory Specialist

This individual is responsible to apply knowledge of clinical trial operations, Good Clinical Practice (GCP), and ICH guidelines to assure regulatory compliance in all clinical trials conducted at CTNx. Primary focus to prepare study documents for trial start up including Investigator Agreements, initial IRB submissions and electronic regulatory binder creation.

Responsibilities:

• Complete, collect, store, and distribute regulatory documentation required by regulatory agencies, sponsors and local SOPs.
• Utilizes electronic regulatory platform, Florence Healthcare, to route and maintain regulatory documents.
• Troubleshoots and provides system training to users in the Florence system.
• Communicates with sponsors, monitors and researchers to assure the compliance of the study files with regulatory requirements, company SOPs and GCP guidelines.
• Demonstrated data entry skills within a regulated field.
• Assists with preparation for audits and response to audits.
• Maintains study personnel certification records (License, CV, GCP).
• Maintains professional relationships, including frequent and open effective communication with internal and external customers.
• Aides sites with the study feasibility process.

Minimum Qualifications

• Bachelor's degree in an appropriate area of specialization. Degree requirement may be substituted with an equivalent combination of education, training and experience.
• Excellent communication, organization and presentation skills are required.
• Candidate must be able to read, analyze and concisely summarize scientific protocols, regulatory documentation, and applicable law.
• Ability to manage a busy schedule with multiple demanding projects and frequently shifting priorities.
• Must be able to handle confidential and/or sensitive information in an appropriate and professional manner.
• Ability to actively participate as a team player

Preferred Qualifications

• Bachelor’s Degree in Healthcare related field.
• Professional compliance experience in healthcare or research
• Experience working with physicians, staff and administrators, preferably within a research setting.
• Past study coordinating experience as a Clinical Research Coordinator

A background check will be completed for the right candidate prior to employment.

For more information about CTNx: '

Work Location:

• One location

Work Remotely

• No

Job Type: Full-time

Salary: $50,000.00 - $60,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Cleveland, OH: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• Study Coordinating: 1 year (Preferred)

Work Location: In person

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