The Johnson &Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide.
Our portfolio ranges across several distinct business units : Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and non-
prescription pharmaceutical products.
Our mission is to care for people around the world by developing innovative products and solutions that are grounded in deep human insights, backed by science that is intuitive, and provide irresistible experiences.
To support our Worldwide Research & Development operation, we are building a complex R&D support center in Warsaw, Poland, to be fully integrated in the global R&D footprint and strategy, helping consumers live healthy and vibrant lives.
Clinical Research Associate (CRA)
Location : Warsaw, Poland
Full time permanent contract
Role Overview :
Aid to initiate, manage and monitor operational aspects of global company sponsored clinical trials in accordance with Johnson & Johnson global standards / guidelines and international regulations (GCP / ICH), including tracking clinical path activities, oversight, budget and timelines, reporting and acting as liaison with study sites and external service providers.
You will have the following areas of responsibility :
Assist Study Manager to prepare study-specific documents.
Assist the Study Manager to manage and provide guidance to working groups as needed.
Assist or represent the Study Manager as department representative in assigned cross functional teams.
Manage preparation of Clinical Trial Agreements, Transfer of Obligations, purchase orders and site contracts.
Actively participate in the evaluation and selection of qualified external service providers (ESP).
Ensure Sponsor oversight by monitoring the progress of studies and performance of ESPs on a continual basis.
Ensure that clinical trials are conducted in compliance with the study protocol and all contractual agreements to ensure patient safety, quality data and accurate study timelines, budgets and quality standards are met.
Set-up and proactively maintain Trial Master Files to ensure inspection readiness.
Oversee and track subject recruitment and retention.
Qualifications and experience of the successful candidate :
Education : Minimum of a Bachelor of Science degree in Nursing, Pharmacy or scientific field, or equivalent required
Experience : Minimum 2 years direct industry experience or 1 year with PhD or Pharm D
Fluent level of Polish and English
Structured and well-organized way of work with attention to detail
Must have good communication skills (both oral and written) and be able to work effectively in cross-functional teams both internally and externally to the organization
Demonstrated working knowledge of the principles of drug and device development
Proficiency in GCP and ICH regulations
Previous experience with Phase 1 clinical studies is preferred
Experience writing and maintaining SOPs
We Offer :
Unique opportunity to become part of a global consumer healthcare market leader
Versatile and fulfilling role in a dynamic and international corporation
Work in a supportive and highly professional team
Further opportunities for professional development and career growth
Motivating financial remuneration & numerous employee benefits
If you are interested in this role and you fulfill the requirements set above, do not hesitate to send us your CV and cover letter in English.