Clinical Research Associate
2 giorni fa
Company Overview: Mil Fortrea Clinical Development Ltd Filiale Italiana is a leading global contract research organization with a passion for scientific rigor and decades of clinical development experience.
Job Summary: We are seeking a highly motivated Clinical Research Associate to join our team in site monitoring responsibilities for clinical trials. As a key member of our site management team, you will be responsible for conducting site initiation visits, routine monitoring visits, and close-out visits according to Fortrea's Standard Operating Procedures (SOPs), ICH guidelines and GCP.
Key Responsibilities:
- Conduct site initiation visits to ensure that the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study.
- Perform eligibility review, verify that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
- Ensure the integrity of the source data reported by careful source document review.
- Monitor data for missing or implausible data.
- Prepare and submit accurate and timely trip reports.
- Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems.
- Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management.
Requirements:
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
- A minimum of 2 years of Clinical Monitoring experience.
- Mandatory CRA certification as per Ministerial Decree.
- Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
Benefits:
- Estimated salary: €45,000 - €60,000 per year, depending on experience.
- Travel opportunities to over 90 countries.
- Collaborative work environment with a passionate team.
Others:
- This role requires 60% travel time.
- The ideal candidate will have excellent communication and problem-solving skills.
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