Description

Job Description

Job Description

Ensures that all research activities are conducted in compliance with approved study protocols, ICH-GCP guidelines, institutional policies, and local regulatory requirements, while safeguarding participant safety and data integrity. Supports investigators, manages research staff, and strengthens research governance, quality, and performance across the organization.

Responsibilities

Research Governance and Regulatory Compliance

• Ensures all research studies and clinical trials are conducted in full compliance with ICH-GCP, approved protocols, institutional policies, and applicable regulatory requirements.
• Acts as the operational interface with regulatory authorities, including DHA, MOHAP, and EDE, for research-related reporting and compliance matters.
• Prepares for and supports internal and external audits, inspections, and monitoring visits.
• Drafts, reviews, and maintains Standard Operating Procedures (SOPs) related to research activities to ensure regulatory readiness and consistency of practice.
• Maintains complete, accurate, and audit-ready documentation for all study-related activities.

Clinical Study and Trial Management

• Oversees the end-to-end conduct of clinical research studies and trials, from feasibility assessment through study close-out.
• Acts as the central point of contact for sponsors, CROs, and external stakeholders during study set-up, conduct, and closure.
• Leads and coordinates feasibility assessments in collaboration with internal departments to confirm operational readiness.
• Oversees study initiation, monitoring, and close-out meetings, ensuring timely resolution of issues and findings.
• Reviews recruitment strategies, study tools, and timelines to ensure enrolment targets are realistic and achieved.
• Oversees the reporting and management of adverse events in accordance with study protocols and SOPs.

Data Integrity and Operational Oversight

• Oversees the collection, recording, and maintenance of accurate participant and study data in accordance with protocol and regulatory requirements, ensuring data integrity and confidentiality.
• Oversees study databases, including data entry, validation, and quality controls.
• Oversees the collection, processing, storage, and shipment of biological samples as required by study protocols.
• Ensures the maintenance of complete and compliant Site Files and study-related inventories.

Investigator and Academic Research Support

• Provides operational and methodological support to Principal Investigators for academic and sponsored research projects.
• Supports study design, protocol development, and preparation of essential study documentation.
• Oversees regulatory submissions and approvals for investigator-initiated and sponsored research.
• Supports data collection, analysis activities, and the preparation of abstracts, manuscripts, and research reports.
• Leads and coordinates grant application submissions with internal and external investigators.

Financial and Contractual Oversight

• Reviews study contracts and budgets in collaboration with internal departments and external sponsors.
• Oversees research invoicing activities and monitors financial milestones to ensure alignment with contractual agreements.

People Management and Performance Oversight

• Line manages Research Associates and Trial Administrators.
• Provides guidance, coaching, and training to research staff to ensure high performance and regulatory compliance.
• Conducts performance development reviews, implements personal development plans, and addresses performance issues.
• Reviews the overall study portfolio to identify risks, gaps, and opportunities for improvement or growth, escalating concerns to the Director of Research Operations as required.

Communication, Collaboration and Education

• Serves as a key liaison with investigators, clinicians, sponsors, CROs, and multidisciplinary teams to support successful study execution.
• Leads discussions with external partners to support and expand institutional research collaborations.
• Trains and mentors staff on clinical trial procedures, GCP principles, and best practices.
• Actively promotes research awareness and opportunities across the organization and participates in ongoing professional development activities.

Qualifications

• Bachelor’s Degree in Life Sciences, Nursing, Medicine, Pharmacy, or a related field
• Master’s Degree or higher qualification in Life Sciences, Clinical Research, Healthcare Management, or a related field preferred
• Minimum of five (5) years’ experience as a Clinical Study Coordinator or equivalent role within a hospital or clinical trials environment with at least two (2) years’ supervisory or line-management experience within a research or clinical environment.
• Knowledge of International Council for Harmonization – Good Clinical Practice (ICH-GCP) guidelines, including their application to the conduct, monitoring, documentation, and regulatory compliance of clinical research studies.
• Knowledge of ICH-GCP, clinical research regulations, and research governance requirements.
• Knowledge of clinical trial operations, documentation standards, and data integrity principles.
• Skills in research coordination, stakeholder management, and regulatory documentation.
• Skills in Microsoft Office applications and clinical trial databases.
• Skills in managing Phase I–IV clinical trials, including participant recruitment, data management, and regulatory compliance.
• Skills in grant application writing and research funding submissions.
• Ability to manage complex research portfolios and multiple stakeholders simultaneously.
• Ability to lead teams, influence collaboration, and drive compliance and performance.