Johnson & Johnson Careers
CRA (Monitor de ensayos clínicos)
Descripción del Trabajo
Requisition ID: 7045171214
The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g., multiple myeloma and prostate cancer), immunology (e.g., rheumatoid arthritis, irritable bowel disease and psoriasis), neuroscience (e.g., schizophrenia, dementia and pain), infectious disease (e.g., HIV/AIDS, Hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g., diabetes). Passionate about our dedication to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare partners, based on partnerships of trust and transparency.
You will be the primary contact point between the sponsor and the investigation site. A Site Manager is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through data-base lock. Your responsibilities include site selection, pre trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out. Partner with the CTA/IDA, LTM and GTM to ensure overall site management while performing tasks for assigned protocols. Contribute to process improvement, training and mentoring of other Site Managers.
- Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
- Acts as primary local company contact for assigned sites for specific trials.
- Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out.
- Ensures site partners are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
- Ensures site study supplies are adequate for trial conduct and that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented. Also arranges the appropriate destruction of clinical supplies.
- Ensures accuracy, validity and completeness of data collected at trial sites.
- Maintains complete, accurate and timely data and essential documents in systems utilized for trial management.
- Writes visit reports and uploads into eTMF within 5 working days for review and approval. Complete follow-up letter to communicate relevant information and required corrective action to the investigator and his/her team with 15 working days.
- Reviews TCF for completeness and ensures archiving retention requirements, including storage in a secure area at all times.
- You will work closely with LTM to ensure CAPA is completed for QA site audits.
- Prepares trial sites for close out, conduct final close out visit.
- You can negotiate investigator budgets at site level, if applicable.
- You will usually br assigned as a coach and mentor to less experienced site managers. May assume additional responsibilities or special initiatives.
What skills are looking for?
- Bachelor's degree. A degree in a health or science related field is preferred.
- A minimum of 3 years of clinical trial monitoring experience.
- Good knowledge of ICH-GCP, company SOP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
- Strong IT skills in appropriate software and company systems.
- Willingness to travel with occasional overnight stay away from home.
- Proficient in speaking and writing in English.
BE VITAL in your career, Be seen for the talent you bring to your work. Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. J&J is committed to delivering a respectful, inclusive and accessible work environment where all employees have equal opportunities to achieve their potential.
Argentina-Buenos Aires-Capital Federal
Janssen Cilag Farmaceutica Srl (fka Pharma Farmace (7425)
Clinical Trial Administration