Clinical Trials Regulatory Coordinator

10 Children's Healthcare of Atlanta, Inc.; United States; On-site; USD 65,000 - 90,000; Full time

Job summary

Children’s Healthcare of Atlanta is seeking a regulatory research professional to support the approval process for clinical research projects and trials in the subspecialty area. You will liaise with the IRB, develop study protocols, and manage regulatory documentation to ensure compliance.

The role requires a Bachelor’s degree in a scientific/health-related field or equivalent experience, with 3 years of research experience and knowledge of regulatory requirements.

Qualifications

• High degree of clerical accuracy with attentiveness to detail
• Excellent written and verbal communication skills
• Ability to organize data and manage documentation

Responsibilities

• Manages departmental regulatory aspects for clinical trial and research activities.
• Serves as the Institutional Review Board liaison for all regulatory activities within the department.
• Develops, maintains, utilizes, and updates protocols, data collection sheets, spreadsheets, and databases for each research process.
• Develops consent forms compliant with federal and institutional guidelines to inform patients/guardians.
• Serves as site regulatory contact for sponsored projects.
• Maintains regulatory documents for study personnel (CVs, licenses, certifications).
• Develops lay summaries for protocols for IRB review.
• Collaborates to prepare documentation for initial review, renewals, amendments, and modifications; writes consents; reviews enrollment data and DSMR reports.
• Supports day-to-day regulatory reporting activities for patients on research protocols.
• Ensures compliance with organizational and regulatory standards; assists in policy development and audits.

Skills

Attention to detail

Communication skills

Independent work

Regulatory knowledge

Education

Bachelor’s degree in a scientific/health-related or business administration program

Tools

Microsoft Office

Regulatory databases

Job description

Children’s Healthcare of Atlanta is seeking a regulatory research professional to support the approval process for clinical research projects and trials in the subspecialty area. You will liaise with the IRB, develop study protocols, and manage regulatory documentation to ensure compliance.

The role requires a Bachelor’s degree in a scientific/health-related field or equivalent experience, with 3 years of research experience and knowledge of regulatory requirements.