Clinical Research Associate II Position

3 settimane fa

Milano, Lombardia, Italia Allucent A tempo pieno

Clinical Research Associate II Role Overview

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies navigate the complex world of clinical trials. We are seeking a Clinical Research Associate II to join our team and contribute to the success of our clients. This position will be responsible for independently controlling and monitoring investigation sites, detecting issues, and providing solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and Good Clinical Practice.

Key Responsibilities:

  • Govern Quality Standards for trial monitoring activities.
  • Perform Selection, Initiation, Monitoring, and Closure Visits at Investigator Sites according to project schedule.
  • Adhere to project guidelines and Allucent SOPs for monitoring requirements.
  • Monitor activities at clinical study sites to ensure adherence to GCP, ICH, SOPs, and study protocols.
  • Track and supervise collection of ongoing study data for purpose of regular project status reporting.
  • Collect and review regulatory documents as required.
  • Prepare site visit reports and telephone contact reports.
  • Maintain and update CTMS in compliance with SOPs and study-specific directives.
  • Act as Document Owner for collected documents.
  • May participate in the start-up process including preparing Informed Consent forms, developing study documents, EC/CA submissions, and/or site contract management.

Requirements:

  • At least 2 years experience in clinical trials.
  • Skills to mentor and train other CRAs in a positive and effective manner.
  • In-depth knowledge of clinical trials and the critical elements for success in clinical trials.
  • Ability to travel for up to 8 days on site per month, depending on the project needs.
  • Strong therapeutic background.
  • Mature management skills demonstrated by calm and thorough review of situations.
  • Proactively identifies and addresses problems.
  • Excellent organizational abilities, and excellent written and oral communication and presentation skills.

Benefits:

  • Comprehensive benefits package per location.
  • Competitive salaries per location.
  • Departmental Study/Training Budget for furthering professional development.
  • Flexible Working hours (within reason).
  • Leadership and mentoring opportunities in a dynamic work environment.
  • Loyalty Award Program in recognition of loyalty and commitment of longstanding employees.
  • Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects.

We offer an exciting opportunity to join a growing company and contribute to the success of our clients. If you are a motivated and experienced Clinical Research Associate II, please submit your application.

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