Clinical Trials Compliance Lead

Accel Research Sites; Florida; On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, vision

401k with safe harbor match

Job summary

Accel Research Sites in the United States seeks a Clinical Research Regulatory Specialist to manage regulatory compliance, documentation, and GCP/SOP training across multiple sites. This role ensures QA readiness and supports ongoing quality improvement initiatives.

You will maintain regulatory binders, coordinate IRB communications, assist with regulatory filings, and ensure readiness for audits while supporting team training and process improvements.

Qualifications

• Bachelor’s degree required and 1 year regulatory experience.
• Knowledge of GCP/ICH guidelines required.
• Strong organizational, written and verbal communication skills.

Responsibilities

• Maintain regulatory documents/binders for audits and filings.
• Follow SOPs and guide staff for compliance.
• Coordinate IRB communication and sponsor interactions.
• Assist with regulatory filings and development of supporting documents.
• Distribute IND safety reports to investigators and team.
• Archive technical documents and reproduce as needed.
• Track sponsor and IRB approvals and renewals.
• Ensure tasks comply with federal regulations and ICH/GCP.
• Support training programs and other duties as assigned.

Skills

Typing 40 wpm

Organizational skills

Attention to detail

Math proficiency

Written communication

Verbal communication

Interpersonal skills

Listening skills

Independent work

HIPAA compliance

Problem-solving

Education

Bachelor’s degree

Job description

Accel Research Sites in the United States seeks a Clinical Research Regulatory Specialist to manage regulatory compliance, documentation, and GCP/SOP training across multiple sites. This role ensures QA readiness and supports ongoing quality improvement initiatives.

You will maintain regulatory binders, coordinate IRB communications, assist with regulatory filings, and ensure readiness for audits while supporting team training and process improvements.