Start-up Associate Georgia

Start-up Associate

Join our team as a Start-up Associate in Georgia.

Start-up Associate is responsible for biomedical research is started within targeted country start up timelines and client satisfaction, good quality of submission dossiers and good communication.

Position is in Georgia (Tbilisi).

Responsibilities:

• Participate (provide SSU feedback) in the evaluation and selection of qualified investigators and sites for clinical trial conduct
• Negotiate clinical trial contracts with Investigational sites, Institutions, Investigators to ensure that local regulations are met
• TMF filing preparation and maintenance site contracts and related documentation to store and archive them
• Confirm submission strategy and timelines for the initial study submission/approval and amendments submission/approval during the study duration. Keep initially agreed timelines
• Prepare and submit required clinical trial applications, reports, and other documentation to applicable Authorities (CA/LEC) for initial clinical trial approval and amendments approval, notifications submission during the study duration
• Prepare submission documents and share with the site for LEC submission
• Follow up with the site and ensure that submission is done, and approval is received
• Coordinate communication with applicable Authorities and respond to their queries
• Prepare clinical trial documents and maintain correspondence and files, store and archive them
• Track changes in the legal framework regulating all aspects of the conduct of biomedicinal research and update about the changes
• Support CRA in preparation and negotiation of clinical trial agreements with investigators and institutions
• Collect/support CRA with the collection of the site essential documents required for IP release approval and compile the IP pack of good quality which corresponds to local regulations to initiate the study in the specific country
• Collaborate on other projects related to the company activities

Requirements:

• University degree in Life Science field (Medicine, Pharmacy and etc.)
• Fluent English language
• 2+ year’s experience in Clinical Research field and at least 1 year experience in CA/LEC submissions in Georgia
• Good knowledge of local biomedical trial regulatory requirements and ICH-GCP
• Time management and problem-solving skills
• Ability to work independently and in a team

Benefits of being a part of our team:

• Professional growth and career opportunities
• Supportive work environment
• Additional benefits (bonus system, additional health insurance and etc.)
• International team

 

Job Category: Clinical Research
Job Type: Full Time
Job Location: Georgia
Job Specification: R2

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