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Start-Up Associate

2 months ago

California, United States Biomapas Full time

Join our global team as a freelance Start-up Associate

Start-up Associate

is responsible for biomedical research start within a targeted country start-up timelines and client satisfaction, good quality of submission dossiers, and good communication with EC and CA and investigators. We have various freelance, part-time, remote vacancies for Local Safety Officers (LSO) for studies we are running in Europe or CIS region. Location:

Various (EU or CIS regions) Responsibilities:

Participate (provide SSU feedback) in the evaluation and selection of qualified investigators and sites for clinical trial conduct 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.) 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 International team Biomapas is a functional and full outsourcing solution provider to the global life science industry. As a trusted partner for biopharmaceutical and medical device companies, we have one-stop-shop clinical research capabilities in high recruiting countries, delivering regulatory, pharmacovigilance and medical information excellence across Europe, CIS, EAEU, MENA, LATAM regions and the US throughout the entire product lifecycle. Leave us your resume.

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