Clinical Research Regulatory Specialist
Translated automatically from the original posting. Read the original in Georgian →
Joint Stock Company "National Center for Lung Health" is announcing a vacancy for the position of Clinical Research Regulatory Specialist (CRA / Clinical Research Associate).
Main functions and responsibilities:
Clinical Research Regulatory Specialist will be responsible for coordinating regulatory and administrative processes related to clinical trials, including managing procedures for importing medical devices required for the study into Georgia.
The activity includes:
Researching and gathering information on current regulations, requirements, and procedures related to importing medical devices within the framework of clinical trials Determining the necessary documentation and requirements for importing/exporting medical devices within the study Preparing, organizing, and submitting regulatory and administrative documentation to relevant authorities Preparing applications, letters, forms, and attached documents related to importing medical devices Communicating with relevant government agencies and other involved parties Monitoring the status of submitted applications and documentation, and timely submission of additional information/documentation if necessary Coordinating with the study sponsor, CRO, principal investigator, research team, logistics, and other relevant partners Administrative coordination of the process of delivering, importing, and receiving medical devices at the research center Archiving and maintaining orderly storage of regulatory documentation related to the study Continuously updating study documentation and maintaining relevant records Monitoring changes in regulatory requirements during the study and adjusting processes as needed Ensuring compliance of study documentation and procedures with current regulations, study protocol, and Good Clinical Practice (GCP) principles.
Research activities:
Close collaboration with the research team to effectively implement administrative and regulatory processes Participating in preparing, managing, and updating clinical trial documentation Controlling deadlines for necessary documents within the study and planning corresponding actions Preparing and submitting documentation according to the sponsor's and other stakeholders' requirements Participating in organizing regulatory documentation for monitoring visits and audits Identifying, investigating, and organizing solutions for administrative issues related to the study's progress Ensuring quality control of the study and compliance with GCP requirements
Main areas of responsibility:
- Research - Searching and analyzing regulatory requirements related to clinical trials and import of medical devices
- Preparation - Preparing necessary applications, letters, forms, and supporting documentation
- Submission - Submitting documentation to relevant authorities and organizations
- Monitoring - Constantly controlling applications, permits, responses, and process status
- Coordination - Ensuring communication between the research team, sponsor, CRO, government agencies, and other involved parties
- Documentation - Proper recording of all stages, organizing and archiving documents.
Qualification Requirements:
- Higher education in medicine, biology, pharmacy, healthcare, or related fields
- Experience working in clinical trials - desirable
- Good Clinical Practice (GCP) certificate - desirable
- Interest in regulatory requirements for clinical trials and ability to research/study them;
- High sense of responsibility and attention to detail
- English language skills - essential
- Knowledge of office programs (MS Word, Excel, Outlook, etc.)
- Ability to communicate effectively with various authorities and professional groups
Additional advantages:
- Experience in clinical trial administration or regulatory affairs
- Experience working on projects related to medical devices
- Experience with import or regulatory procedures related to medical devices
- Experience in managing clinical trial documentation and regulatory processes
- Experience collaborating with research sponsors or CROs.
Work Schedule and Conditions:
Remuneration: hourly agreement
Application deadline: 1 week
Interested parties, please send your CV to the following emails:
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