Clinical Research Associate

2 giorni fa


Roma, Lazio, Italia Allucent A tempo pieno
Job Title: Sr. Clinical Research Associate

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies navigate the complex world of clinical trials. We are seeking a Sr. Clinical Research Associate to join our team.

Key Responsibilities:
  • Govern quality standards for trial monitoring activities.
  • Perform selection, initiation, monitoring, and closure visits at investigator sites.
  • 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 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.
  • Participate in start-up process, including preparing informed consent forms, developing study documents, EC/CA submissions, and/or site contract management.
Requirements:
  • At least three years of clinical monitoring experience and/or relevant clinical trial experience.
  • Relevant life science degree/healthcare/nursing background and/or related degree.
  • Sound knowledge of medical terminology and clinical monitoring process.
  • Strong communication skills in local and English language in both written and verbal.
  • Strong interpersonal and organizational skills.
  • Ability to translate guidelines, rules, and regulations into clear and usable recommendations.
  • Representative, outgoing, and client-focused.
  • Ability to work in a fast-paced, challenging environment of a growing company.
  • In-depth therapeutic and protocol knowledge.
  • Ability to travel for up to 8 days on site per month, depending on project needs.
Benefits:
  • Comprehensive benefits package per location.
  • Competitive salaries per location.
  • Departmental Study/Training Budget for furthering professional development.
  • Flexible working hours (within reason).
  • Opportunity for remote/hybrid working depending on location.
  • Leadership and mentoring opportunities.
  • Participation in our Buddy Program as a new or existing employee.
  • Internal growth opportunities and career progression.
  • Financially rewarding internal employee referral program.
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms.
  • Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects.
  • Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees.


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