DESCRIPTION

Job Purpose:

The Manager of Research Compliance for Clinical Trials is responsible for overseeing and ensuring adherence to all regulatory requirements and ethical standards related to clinical research conducted at the University. This individual will collaborate with researchers, administrators, and regulatory bodies to develop, implement, and monitor compliance programs and policies. The Manager will also provide guidance and support to ensure that all clinical trials are conducted ethically, safely, and in compliance with relevant laws and regulations.

Key Roles & Responsibilities:

Strategic Responsibilities:

• Contribute to the development of the Department's strategy with respect to research compliance systems and processes.
• Contribute to the development of the Department's policies and procedures, in line with the overall business objectives of the University, ensuring they promote leading practices and excellence.
• Contribute to the development and management of the Department’s KPIs and report back on a timely basis to ensure that the KPIs are being met.

Operational Responsibilities:

• Manage and oversee research compliance function, including research conflict of interest, animal welfare, export control and human subjects.
• Develop and implement policies, procedures, and training programs to ensure compliance with regulatory requirements, including but not limited to Good Clinical Practice (GCP), and institutional policies.
• Coordinate with local government agencies including SEHA and the DOH to ensure KU is meeting their regulatory and reporting requirements, and to ensure KU is made aware of changes to the regulations.
• Collaborate with Principal Investigators (PIs), research teams, and regulatory agencies to ensure that clinical trials are conducted in accordance with approved protocols and regulatory standards.
• Review and assess protocols, informed consent forms, and other study-related documents to ensure compliance with applicable regulations and ethical principles.
• Provide guidance and support to researchers on regulatory requirements, study design, protocol development, and informed consent processes.
• Monitor ongoing clinical trials to ensure compliance with regulatory requirements and institutional policies, including conducting audits and site visits as needed.
• Investigate and respond to reports of non-compliance or research misconduct, in collaboration with appropriate stakeholders and regulatory bodies.
• Develop and maintain systems for tracking and reporting clinical trial activities, including maintaining study documentation and records in accordance with regulatory requirements.
• Stay abreast of changes in regulations, guidelines, and best practices related to clinical research compliance, and ensure that policies and procedures are updated accordingly.
• Serve as a resource for faculty, staff, and students on issues related to research compliance, providing guidance and education as needed.
• Collaborate with other compliance offices and departments within the University to ensure coordinated efforts and consistency in compliance activities.
• Ensure adherence to the University's information security policies and procedures, and report breaches or other security risks accordingly.
• Ensure coordination with other departments to facilitate the accomplishment of tasks and responsibilities, as and when needed.
• Perform any other tasks assigned by Line Manager.

Supervisory Responsibilities:

• Provide coaching, guidance and mentoring as required to enhance the internal capabilities of the team and ensure the achievement of established objectives and plans.
• Recommend appropriate training courses as per the pre-determined training needs, evaluate their effectiveness, and monitor their results.
• Carry out performance appraisals for subordinates according to planned schedules and recommend necessary actions as per the applied practices.
• Conduct periodic meetings with subordinates to ensure that priorities are clear and workflow is running smoothly.
• Follow-up on employees' administrative affairs such as vacations, leaves and other administrative and related affairs.

QUALIFICATIONS

Qualifications:

• Advanced degree in a relevant field required; (e.g., Master's, JD, or PhD) preferred. Strong understanding of regulatory requirements and ethical principles governing clinical research.

Required Experience:

• Expats: A minimum 12 years of relevant experience.
• UAE Nationals: A minimum 8 years of relevant experience.

Should you require further assistance or if you face any issue with the online application, please feel to contact the Recruitment Team (recruitmentteam@ku.ac.ae).