Senior Clinical Research Associate (CRA)
Johnson & Johnson
Warsaw, Poland
17 d. temu

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.

Senior Clinical Research Associate (CRA)

Role Overview :

With minimal direction and supervision : 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 but not limited to tracking clinical path activities, oversight, budget and timelines, reporting and acting as liaison with study sites and external service providers) and / or support more senior managers with operational tasks needed in management of global clinical trials.

You will have the following areas of responsibility :

  • Ensure preparation of / prepare study-specific documents.
  • Ensure review of case report forms (CRFs), CRF completion guidelines, data management plans, statistical analysis plans, inspection readiness plans, and patient-
  • reported outcome scales and questionnaires.

  • Ensure preparation of Clinical Trial Agreements / site contracts, Transfer of Obligations & Compliance actions.
  • 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.
  • Ensure maintenance of Trial Master Files for inspection readiness.
  • Oversee and track subject recruitment and retention.
  • Generate protocol-specific documents required for registry / posting of clinical studies on public registries.
  • Qualifications

    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 5 years direct industry experience or 3 years with PhD or Pharm D
  • Prior experience with Phase 1 clinical studies
  • 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
  • Experience writing and maintaining SOPs
  • Demonstrated working knowledge of the principles of drug and device development
  • Proficiency in GCP and ICH regulations
  • 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.

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