
Clinical Research Compliance Professional
Há 5 dias
Job Title: Regulatory Compliance Specialist
This role involves coordinating with investigators, regulatory authorities, and other stakeholders to ensure compliance with relevant regulations and guidelines. The ideal candidate will possess a strong understanding of ICH, RA, IRB/IEC regulations and have experience in clinical research.
About the Role:
- Coordinate site start-up activities and maintenance, ensuring timely submission of required documents to regulatory authorities.
- Maintain awareness of regulatory legislation, guidance, and practice in assigned countries.
- Liaise with internal and external vendors regarding Regulatory Authority submissions.
Key Responsibilities:
- Review and prepare routine submissions filed to IRB/IEC/Third body/Regulatory Authorities.
- Ensure assigned start-up and maintenance activities are on track, in accordance with client expectations and applicable laws and guidelines.
Qualifications and Requirements:
- University/College degree or certification in a related allied health profession from an accredited institution.
- 2 years' work experience in clinical research, including a strong working knowledge of ICH guidelines and RA, IRB/IEC regulations.
Desirable Qualifications:
- Minimum 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 negotiation process.
-
Curitiba, Brasil Bebeeregulatory Tempo inteiroJob Title: Regulatory Compliance SpecialistThis role involves coordinating with investigators, regulatory authorities, and other stakeholders to ensure compliance with relevant regulations and guidelines.The ideal candidate will possess a strong understanding of ICH, RA, IRB/IEC regulations and have experience in clinical research.About the Role:Coordinate...
-
Clinical Research Professional
2 semanas atrás
Curitiba, Paraná, Brasil beBeeClinicalResearchAssociate Tempo inteiro R$120.000 - R$165.000Job OverviewParexel FSP is currently seeking to fill the position of Senior Clinical Research Associate. This role will involve site management, monitoring and close-out of assigned clinical trials investigator sites.The successful candidate will be responsible for ensuring patient safety and quality study execution in accordance with applicable prevailing...
-
Senior Clinical Research Associate I
2 semanas atrás
Curitiba, Paraná, Brasil Parexel International Tempo inteiroParexel FSP is hiring multiple Sr CRAs in Brazil The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the...
-
Veeva Specialist _ Veeva Clinical
Há 3 dias
Curitiba, Brasil Hcltech Tempo inteiroInternational Opportunity for Veeva Specialist – Veeva Clinical / Limfinity / JMP Are you a professional ready to take your expertise global?HCLTech is hiring for a high-impact international project in Mexico City, and we're looking for talented individuals with experience in Veeva Clinical, Limfinity LIMS, and JMP.This is your opportunity to work at the...
-
Clinical Operations Specialist
Há 18 horas
Curitiba, Brasil Bebeeregulatory Tempo inteiroJob Title: Clinical Operations SpecialistThe clinical operations specialist plays a vital role in ensuring the safety, efficiency, and compliance of pharmacovigilance systems.Main Responsibilities:Collaborating with cross-functional teams to gather requirements and implement solutions for pharmacovigilance systems and workflowsPartnering with regulatory...
-
Clinical Development Specialist
Há 7 dias
Curitiba, Brasil beBeeRegulatory Tempo inteiroJob Title Key Responsibilities: Act as a primary contact for investigative sites and ensure all documents required are collected in a timely manner. Collect and track all the necessary documents, perform quality reviews, format and compile final documents for effective and compliant site activation and maintenance without supervision. Ensure high-quality...
-
Clinical Trial Manager
2 semanas atrás
Curitiba, Paraná, Brasil NonStop Consulting Tempo inteiroClinical Trial ManagerMy Client who is a full-service clinical CRO is currently looking for a Clinical Trial Manager (PM) to join their team in Buenos Aires, Argentina or San Paolo, Brazil. They provide Phase I to IV clinical development services to biotechnology, pharmaceutical and medical devices companies. They offer an industry recognised 2 month...
-
Clinical Quality Specialist
Há 7 dias
Curitiba, Brasil Remote Jobs Tempo inteiroAbout Grow Therapy Grow Therapy is on a mission to serve as the trusted partner for therapists growing their practice, and patients accessing high-quality care. Powered by technology, we are a three-sided marketplace that empowers providers, augments insurance payors, and serves patients. Following the mass increase in depression and anxiety, the need for...
-
Field Clinical Representative CRM
4 semanas atrás
Curitiba, Paraná, Brasil Boston Scientific Corporation Tempo inteiro**Additional Location(s)**: N/A**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance**At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the...
-
Business Research Specialist
2 semanas atrás
Curitiba, Paraná, Brasil beBeeResearch Tempo inteiro R$69.000 - R$91.500Job OverviewAs a Research Professional, you will be instrumental in driving the research and development of high-demand forms across multiple countries. Your primary role will involve researching and identifying forms and templates that meet specific requirements.You will analyze search trends, competitor offerings, and market data to prioritize forms based...