Protocol Analyst Trainee II
QIMA Life Sciences (ICF) is a fast-growing division of the QIMA Group, dedicated to providing comprehensive services for the life sciences industry – from R&D to market launch.
In Brazil, we operate through 5 entities – ICF, Apex Science, Labmass, Lychnoflora, and CP Quali – with 450 talented professionals providing services ranging from clinical trials to quality control. QIMA is more than a testing, inspection, certification, and compliance company. Our mission is to offer clients smart solutions to create products that consumers can trust. With a global reach spanning over 100 countries, QIMA serves the consumer goods, food, and life sciences industries, supporting more than 30,000 brands, retailers, manufacturers, and food producers. The company combines local expertise with digital solutions to bring precision and visibility to quality, safety, and compliance data. What sets QIMA apart is its unique culture: 6,000 employees live and make decisions every day according to QIMA's values. With customer passion, integrity, and a commitment to simplifying things, QIMA continues to revolutionize the testing, inspection, and certification industry.
Perform temperature and humidity control of the clinical unit pharmacy; assist in receiving medications to be used in the clinical stage; assist in preparing the unitization schedule according to the hospitalization schedule; participate in and organize the unitization (preparation and separation) of medications to be administered to research participants, following the hospitalization schedule; support the organization of the clinical unit pharmacy; perform the design of bioequivalence/relative bioavailability studies through critical analyses (including the first and second stages of the process); draft the bioequivalence protocol (Portuguese and English); draft the pharmacology of the medication; submit to the CEP all documents related to the study: protocols, TCLEs, infrastructure letter, and principal investigator declaration; amendment letter (when applicable), notifications (when applicable), response letters (when applicable), monitoring reports (partial and final), media; draft and send, when necessary, study-related documents to the sponsor: notifications (pregnancy and/or serious adverse event); draft and send to ANVISA protocols (when necessary) and serious adverse event notifications; draft and send inquiries to ANVISA to clarify doubts related to a specific protocol and/or related to a critical analysis (studies in general); confirm the protocol drafting task in Microsiga; attach documents in the Microsiga data management system; collect, within the Plataforma Brasil, the opinions related to the project; perform the evaluation of documentation and respond to protocol inquiries sent by sponsors; keep the Protocol department's document spreadsheet updated.
Research and reading of scientific articles; drafting of protocols and documents related to bioequivalence studies; assistance in drafting responses to Anvisa requirements and Ethics Committee (CEP) pending issues; submission of protocols to the CEP; contact with the commercial team and clients for discussion and alignment of protocols.
Degree completed in Pharmacy; Intermediate to advanced English, with a focus on reading and interpreting scientific articles; Proficiency in reading and researching scientific articles; Knowledge of legislation applicable to bioequivalence and clinical research; Knowledge of scientific methodology; Basic knowledge of pharmacology; Basic knowledge of statistics; Knowledge of IT and Office Package; Experience in drafting protocols and documents related to bioequivalence studies; Knowledge of protocol submission to the Ethics Committee (CEP); Experience in addressing Anvisa requirements and CEP pending issues; Contact with commercial teams and clients for discussion and alignment of protocols. Benefits:
Day off Health Plan Dental Plan Food Voucher Transport Voucher Breakfast and Afternoon Snack Wellhub
Clinical Unit – Aparecida de Goiânia/GO