Clinical Research Associate

Latis is hiring an experienced CRA preferably located in Lombardia, Emilia Romagna or Liguria

Job Overview

Perform monitoring work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions:

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking, recruitment and enrollment, case report form (CRF) completion, and data query generation and resolution.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Center File (ICF) is maintained in accordance with GCP and local regulatory requirements.
• Submit regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.

Qualifications:

• Bachelor's and Master's Degree in scientific discipline or health care
• Requires at least 2 years of on-site monitoring experience
• In possession of CRA Certification according to Ministerial Decree dated 15.11.2011
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.