Clinical Research Associate II

6 giorni fa

Roma, Lazio, Italia Allergan A tempo pieno
Job Summary

We are seeking a highly skilled Clinical Research Associate II to join our team at Allergan. As a key member of our site monitoring and management team, you will be responsible for ensuring the successful execution of clinical studies at investigative sites.

Key Responsibilities:
  1. Study Site Monitoring: Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Allergan Standard Operating Procedures (SOPs) and business processes.
  2. Site Management: Oversee the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives. Proactively manage the site and ensure action plans are put into place as needed to ensure compliance.
  3. Regulatory Compliance: Ensure regulatory inspection readiness at assigned clinical sites and ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
  4. Study Subject Safety: Ensure safety and protection of study subjects through compliance with the study monitoring plan, Allergan SOPs, ICH Guidelines, and applicable regulations.
  5. Training and Development: Train study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
  6. Financial Management: Manage investigator payments as per executed contract obligations and negotiate investigator/hospital agreements with stakeholders.
Requirements:
  1. Appropriate tertiary qualification, health-related (e.g., Medical, Scientific) preferred.
  2. Minimum of 1 year of clinically-related experience. A previous experience in Oncology is a plus.
  3. Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
  4. Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines, and applicable regulations.
  5. Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
  6. Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity.
  7. Demonstrated business ethics and integrity.
  8. Fluency in English and Italian.
  9. Availability to travel.

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