Global Clinical Compliance Specialist

One CoreDev IT Inc. (CORE); Philippines; On-site; PHP 600,000 - 900,000; Full time

Job summary

One CoreDev IT Inc. (CORE) seeks an Offshore Compliance Specialist to ensure regulatory and ethical standards in clinical studies and protect participant welfare.

You will audit study documents, verify data, and collaborate with team leads to resolve compliance issues in line with CRIO tagging workflows and source documents. This role requires onsite work and willingness to align with US time zones for study activities.

Qualifications

• SDV and regulatory experience is essential.
• Strong attention to detail and accuracy in data handling.
• Willingness to work onsite and adapt to US hours.

Responsibilities

• Ensure adherence to FDA, EMA, ICH GCP and protocol requirements.
• Perform Source Data Verification and auditing during study visits.
• Identify issues and provide guidance to staff on quality controls.

Skills

SDV

Clinical Research

Regulatory Compliance

Attention to detail

US time zone shift

Communication

Collaboration

Job description

One CoreDev IT Inc. (CORE) seeks an Offshore Compliance Specialist to ensure regulatory and ethical standards in clinical studies and protect participant welfare.

You will audit study documents, verify data, and collaborate with team leads to resolve compliance issues in line with CRIO tagging workflows and source documents. This role requires onsite work and willingness to align with US time zones for study activities.