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Regulatory Compliance Coordinator

1 tydzień temu

Warszawa, Mazovia, Polska Johnson & Johnson Pełny etat

Our Team

Johnson & Johnson is committed to building a diverse and inclusive workplace that reflects the communities we serve. We are seeking a Regulatory Compliance Coordinator to join our team and support our mission to provide innovative medical solutions that improve health and well-being around the world.

In this role, you will be responsible for ensuring the successful execution of clinical trials from start to finish. Your primary responsibility will be to serve as the primary contact point between the Sponsor and the Investigational Site. You will be assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure.

You may participate in site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. The Associate, Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and TDL (Trial Delivery Leader) to ensure overall site management while performing trial related activities for assigned protocols.

Main Responsibilities:

  • Acts as primary local company contact for assigned sites for specific trials.
  • May participate in site feasibility and/or Site Qualification Visit.
  • Attends/participates in investigator meetings as needed.
  • Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies.

Qualifications

  • A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences, or related scientific field (or equivalent experience).
  • A minimum of 1 year of clinical trial monitoring experience is required.