Clinical Research Specialist

1 semana atrás

Recife, Brasil Bebeeregulatory Tempo inteiro

Job OverviewThe successful candidate will be the primary point of contact for investigative sites during site start-up activities and maintenance.
This role involves the collection of required investigator and essential documents for a study, ensuring timely submission to EC/IRB/Third body/Regulatory Authorities and compliance with applicable regulations and sponsor specifications.The individual in this position will proactively interact with EC/IRB/Third body/Regulatory Authorities to provide guidance on requirements and maintain awareness of current regulatory standards related to submissions.
Additionally, they will serve as a local expert in project start-up activities for a particular country or region, acting as a 'knowledge resource' to mentor and train new hires and less-experienced department colleagues if suitable.ResponsibilitiesMaintain awareness of regulatory legislation, guidance, and practice in the assigned countries.Coordinate, collect and organize data and information required by EC/IRB/Third body/Regulatory Authority, including the preparation of study documentation such as the country application form and cover letter for sponsor review as applicable.Compile and prepare routine submission filed to IRB/IEC/Third body/Regulatory Authorities (e.g., INDs/CTAs) and liaise with them as applicable regarding submission/approval.Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).
Perform a review of final submission documents as applicable.Ensure that all assigned start-up and maintenance activities are on track, in accordance with client expectations and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs and quality standards.Prevent and escalate study issues appropriately and in a timely fashion.QualificationsUniversity/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology), AND 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations.Fortrea may consider relevant and equivalent experience in lieu of educational requirements.In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations will be considered.ExperienceMinimum of 3 years of experience in clinical development or start-up/regulatory process.Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites.Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them.Work EnvironmentGeneral Office Environment.

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