Clinical Trials Regulatory Specialist

ActivMed Practices & Research, LLC.; Burlington; On-site; CAD 65,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Health savings accounts

Supplemental insurances

401k plan with safe harbor match

Job summary

Alcanza Clinical Research is seeking a Regulatory Specialist to ensure GCP/SOP compliance across multiple sites. You will manage regulatory documents, liaise with IRB and sponsors, and lead quality control and staff training on regulatory processes.

Responsibilities include maintaining study files, coordinating regulatory filings, distributing safety reports, and supporting audits to keep essential documents up-to-date and audit-ready. A strong attention to detail is essential.

Qualifications

• Bachelor’s degree and a minimum of 2 years in clinical research; 1+ year regulatory experience preferred.
• Knowledge of GCP/ICH guidelines is required.
• Excellent documentation and compliance focus.
• Ability to communicate with IRB, sponsors, and study teams.

Responsibilities

• Maintains regulatory documents/binders for audits and regulatory filings when required.
• Follows SOPs and provides guidance to staff on compliance.
• Facilitates communication with IRB and Sponsors.
• Assists with development of clinical trial support documents and regulatory filings.
• Ensures IND safety reports are distributed for review.
• Assembles and archives technical documents as appropriate.
• Collaborates with the team to support protocol operations.
• Tracks sponsor and IRB approvals and renewals.
• Generates and reviews regulatory data reports.
• Ensures compliance with federal regulations and ICH/GCP.

Skills

Strong organizational skills

Attention to detail

Written & verbal communication

Interpersonal skills

Independent work ability

Integrity & dependability

HIPAA compliance awareness

Education

Bachelor's degree or equivalent in related field

2+ years clinical research regulatory experience

Tools

Microsoft Office

EHR systems

Web applications

Typing 40 wpm

Job description

Alcanza Clinical Research is seeking a Regulatory Specialist to ensure GCP/SOP compliance across multiple sites. You will manage regulatory documents, liaise with IRB and sponsors, and lead quality control and staff training on regulatory processes.

Responsibilities include maintaining study files, coordinating regulatory filings, distributing safety reports, and supporting audits to keep essential documents up-to-date and audit-ready. A strong attention to detail is essential.