Specialist- Medica Research Section

• Develop, review, and update research policies, guidelines, standards, and procedures in alignment with organizational and regulatory requirements.
• Analyze internal and external research audit reports to identify gaps, risks, and areas for improvement in research governance and compliance.
• Prepare detailed audit summary reports, including findings, root cause analysis, and actionable recommendations.
• Design, implement, and monitor Quality Improvement Plans (QIPs) to address audit findings and enhance research processes and regulatory compliance.
• Track progress of QIPs and ensure timely implementation of corrective and preventive actions (CAPA).
• Support the enhancement of research regulatory frameworks and contribute to strengthening institutional research governance.
• Conduct periodic reviews of research practices and processes to ensure adherence to approved policies and standards.
• Collaborate with internal stakeholders to ensure effective implementation of research policies and audit recommendations.
• Maintain accurate documentation of policies, audit reports, QIPs, and related research governance records.
• Prepare analytical reports, dashboards, and presentations for management on research compliance, audit outcomes, and quality performance indicators.
• Participate in research-related committees and provide input on policy development, audit findings, and quality improvement initiatives.
• Support awareness and training initiatives related to research policies, audit processes, and quality standards.
• Contribute to continuous improvement initiatives aimed at enhancing research efficiency, compliance, and regulatory effectiveness.
• Support and oversee clinical trial processes, including protocol review, ethical submissions, regulatory documentation, and study lifecycle tracking.
• Ensure proper documentation, record keeping, and maintenance of research and clinical trial files in compliance with regulatory standards.
• Support inspection and audit readiness for research and clinical trials, ensuring adherence to regulatory requirements.
• Ensure confidentiality, integrity, and proper handling of all research-related data and documentation.
• Perform any other duties as assigned by the line manager.

Qualifications

Minimum Qualification

Master’s degree in healthcare, research, public health, or related field.

Minimum Work Experience

Minimum 3–5 years of experience in research administration, policy development, audit, or quality improvement

Experience in research governance, compliance, or regulatory environments