Compliance Officer, IHD Office

Role Overview

The Research Ethics and Regulatory Compliance Officer provides independent, risk-based oversight of human-participant studies across IHD, helping research teams meet ethics and regulatory requirements from initial approval through study close-out. The role reviews study practices and records, identifies areas for improvement, and advises investigators on corrective steps while leaving study leadership with Principal Investigators and committee authority with ISERC.

Key Responsibilities

• Track approvals, permits, authorizations, expiry dates, and study conditions in a central register; confirm required approvals are in place before research activities begin.
• Check regulatory files for completeness and accuracy, and monitor whether approved protocols and amendments are being followed.
• Plan and carry out routine, risk-based compliance reviews, including checks against approved protocols and Standard Operating Procedures; document deviations and violations and follow up on corrective and preventive actions.
• Prepare written monitoring reports that summarize findings, actions taken, compliance patterns, and recommendations for improving research conduct.
• Review consent forms and observe consent processes to advise on participant understanding, appropriate documentation, privacy, and confidentiality.
• Assess governance of biological samples, including consent, collection, labelling, processing, inventory, transport, shipment, receipt, and long-term storage.
• Review essential study records such as investigator files, training and delegation logs, screening and enrolment records, regulatory correspondence, protocol version histories, and archiving arrangements.
• Advise on data protection practices and audit or inspection readiness, and identify training needs, deliver compliance sessions, and help orient new research staff.

Requirements & Qualifications

• Master’s degree in public health, clinical research, epidemiology, health sciences, pharmacy, nursing, medicine, or a related field.
• At least five years of experience in research ethics, regulatory affairs, research governance, clinical research management, or quality assurance.
• Working knowledge of research ethics, regulatory requirements, and governance frameworks, together with current ICH-GCP certification.
• Experience supporting an institutional ethics review committee, research audit, or regulatory inspection is an advantage.
• Strong analytical and organizational skills, close attention to detail, and the ability to handle confidential information with integrity.
• Clear written communication, sound professional judgement, and the tact to advise diverse research stakeholders constructively.
• Able to work independently with minimal supervision while contributing effectively to a collaborative team, including in demanding situations.