Clinical Quality Control (Clinical Research Associate)

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

About the role

An Offshore Compliance Specialist ensures adherence to regulatory standards, ethical guidelines, and clinical study protocols. The Offshore Compliance Specialist plays a critical role in maintaining the integrity of clinical studies conducted and protecting the rights and welfare of participants.

Key responsibilities

• Ensure compliance with regulations like FDA, EMA, and ICH GCP

• Evaluate study protocols for regulatory and ethical compliance

• Conduct initial audits and inspections during study visits within a 24-48-hour timeframe to assess compliance with protocol and regulatory requirements, including screening, baseline, treatment, end of study, follow-up visits, and safety contacts/e-diary visits

• Identify issues and provide guidance to clinical staff on quality control practices and compliance by raising queries and comments through the primary and secondary tagging system in CRIO regarding corrective actions

• Ensure completion of data entry and relevant sections

• Report missed procedures, missed visits, and out-of-window visits

• Confirm proper documentation and uploading of source documents

• Conduct final audits by examining updates, resolving addressed queries, checking on unresolved queries, and evaluating newly updated sections and uploaded source documents

• Collaborate with the team lead and supervisor to communicate compliance issues and provide feedback

About you

• Strong understanding of Source and EDC systems

• Experience in Source Data Verification (SDV) and Clinical Research (CRA experience preferred)

• Exceptional attention to detail and consistency in process execution

• Amenable to work onsite and on shifting schedule (following US time zone)

• Collaborative - able to follow existing processes initially without trying to change them immediately

• Pleasant and professional communication style

• Open to suggesting improvements after fully understanding the current systems

• Open to improving efficiency through constructive discussions