Clinical Research Associate Role Clinical research associates play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
The primary goal is to ensure the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations, and SOPs.
Key Responsibilities Complete onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs, and study processes.Verify the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to applicable regulations.Ensure proper management and accountability of Investigational Product (IP).
Write and submit reports of investigational site findings and updates applicable tracking systems.Evaluate site performance, identify inconsistencies, and assess risk.Required Skills and Qualifications To excel in this role, you should possess an undergraduate degree or international equivalent in clinical, science, or health-related field from an accredited institution.
A health care professional licensure, such as registered nurse, is also required.
Additionally, previous experience supporting clinical trials, including solid on-site monitoring experience in CROs or pharma companies, is essential.
Travel requirements are significant, with
Fluency in English and host country language is mandatory for effective communication.
Clinical Research • Ituiutaba, Minas Gerais, Brasil