Sobre a vaga
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Johnson & Johnson Consumer Health is recruiting for a R&D Assistant Scientist - Clinical Operations (12 months fixed term contract), located in São José dos Campos, Brazil.
This position will assist in clinical operations study activities for Consumer health products, focused mainly on OTC drugs. Operations activities includes study management and monitoring under GCP compliance, and this person will contribute to the development, planning, startup, conduct, and closure of clinical studies as well as site/CRO qualification and management.
- Act on OTC projects for clinical operations activities, acting as regional focal point to global study teams.
- Execute activities within site initiation and start-up, site/study monitoring, site/study management and site/study close-out per internal SOPs.
- Participates in site assessments, collaborates in pre-trial site assessment visits.
- Ensures site staff have current GCP, protocol and systems trainings to conduct the clinical trial.
- Develop/reviews/approves clinical trials documents, such as study protocol, informed consents, CRF, monitoring plan, investigator brochure, study reports.
- Maintains and archives clinical trial documentation (Trial Master Files) in the v-TMF system.
- Ensures that all Adverse Events (AEs), Serious Adverse Events (SAEs), Product Quality Complaints (PQCs) and Special Situations (SSs) are reported within reporting timelines and documented appropriately.
- Initiates and ensure completion of contracts, clinical study agreements, clinical supply distribution and returns, internal purchase orders.
- Ensures compliance with all applicable GCP regulations and company procedures.
Experiência e competências desejadas
- Bachelor degree in Pharmacy, Biomedical Science or another relevant science field
- Proven experience in Clinical trial activities for drug products
- Basic understanding of clinical research science and processes, and global clinical trial regulations
- Intermediate English
- Advanced English
- Experience on Bioequivalence, Bioavailability or PK studies
- Experience on study management systems as iMedidata-RAVE, oneCTMS, CEDMS, v-TMF Link para vaga: https://www.linkedin.com/jobs/view/2482805146/