Job Description
Clinical Research Associate at NMC Healthcare will be 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 organizations to ensure efficient conduct of the clinical research activities within the NMC Group. This is an Intermediate level full time job. And salary can range between 7000-15000 AED/month.
Responsibilities of Clinical Research Associate
- 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 Organizations (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.
Requirements for Role of Clinical Research Associate
- Bachelor’s or Master’s degree in biological science or a related field.
- 3 – 6 years of experience as a Clinical Research Associate (CRA).
- At least 2+ years of CRA experience in a hospital setting.
Skills And Knowledge Desired
- 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.
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