Job Description

The responsibility of the Clinical Research Associate is to coordinate with prospective clinical researchers in NMC facilities by assisting them in their clinical research application, study design, study progress and conclusion. The role involves close coordination between doctors and internal Scientific and Ethics committees as well as with regulatory bodies, pharma companies and contract research organisations to ensure efficient conduct of the clinical research activities within the NMC Group.



A highly analytical mid-level clinical research associate, with experience in the development of clinical protocol and data management for a number of clinical trials at multiple sites, ensuring compliance with regulatory and ethical bodies. Candidates with relevant experience in a hospital setting would be the first choice. Candidates who have experience in a pharmaceutical company as a CRA can also be considered. Knowledge of regulatory requirements of the Department of Health (DOH) - Abu Dhabi & Al Ain, DHA - Dubai and MOH - Sharjah is desirable not essential.


• Assist the Principal Investigator (PI) in preparing the Study Protocol, Informed Consent Forms, Case Records Forms and study related documents.
• Liaise with the Principal Investigator (PI) for the preparation of the research study application forms to be presented to the Central Scientific Committee, Research & Ethics Committee, and the regulatory departments for review and approval.
• Coordinate with the Contract Research Organisations (CROs) for the planning, setup, and management of clinical trials sponsored by pharma companies in NMC study sites.
• Perform data reconciliation and ensure compliance with SOPs and local regulations, and ICH and GCP guidelines.
• Monitor clinical trials to ensure sponsor and investigator obligations are being met and compliant with applicable local regulatory requirements and ICH-GCP guidelines.
• To be an active part of Protocol Development, Case Records Form Development and Regulatory communications.
• Responsible for the development, maintenance, and periodic updating of Standard Operating Procedures (SOPs) and policies pertaining to the NMC Central Scientific Committee (CSC) and Regional Research and Ethics Committees (RREC).
• Prepare and maintain the IRB submissions and Regulatory documents.
• Provide subject matter expertise for process improvements and quality initiatives.
• Periodic monitoring and reporting of research projects carried out in the NMC Group.


Education

• Bachelor's or Master's degree in biological science or a related field.

Experience

• 3 - 6 years of experience as a Clinical Research Associate (CRA).
• At least 2+ years of CRA experience in a hospital setting.

Skills

• Knowledge of the pharmaceutical industry, terminology, and practices.
• Strong knowledge of guidelines and regulations applicable to conduct clinical research
• Good written and verbal communication skills.
• Proficient with Microsoft Office Word, Excel, and PowerPoint.
• Good understanding of the importance of Good Clinical Practice (GCP)
• Knowledge of statistical data collection and analysis techniques