Clinical Research Associate II

il y a 2 semaines

Paris, Île-de-France Allucent Temps plein
Job Title: Clinical Research Associate II

We are seeking a highly skilled Clinical Research Associate II to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for ensuring the successful execution of clinical trials.

Key Responsibilities:
  • Monitor and control investigation sites to ensure compliance with study protocols and regulatory requirements.
  • Perform site initiation, monitoring, and closure visits to ensure data quality and integrity.
  • Track and supervise the collection of study data to ensure timely and accurate reporting.
  • Review and collect regulatory documents as required.
  • Prepare and submit site visit reports and telephone contact reports.
  • Maintain and update the Clinical Trial Management System (CTMS) in accordance with SOPs and study-specific directives.
  • Act as the main point of contact between the project team and site staff.
  • Collaborate with the Centralized Monitoring Team to evaluate risk-based monitoring activities and prevent issues.
  • Identify and address logistical and practical problems, and develop contingency plans to ensure study success.
  • Ensure the continuous maintenance of the Trial Master File and Investigator Site File.
  • Assist the Project Manager and Clinical Team Leader with the generation of study-specific forms and follow-up with the teams to ensure timely completion and submission.
Requirements:
  • At least 2 years of experience in clinical research.
  • Strong therapeutic background and knowledge of clinical trials.
  • Ability to travel for up to 8 days per month, depending on project needs.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Strong problem-solving and analytical skills.
  • Ability to define and meet project requirements.
  • Flexibility and adaptability in a fast-paced environment.
Benefits:
  • Comprehensive benefits package.
  • Competitive salary.
  • Departmental study/training budget for professional development.
  • Flexible working hours.
  • Opportunity for remote/hybrid working.
  • Leadership and mentoring opportunities.
  • Participation in our Buddy Program.
  • Internal growth opportunities and career progression.
  • Financially rewarding internal employee referral program.
  • Access to online soft-skills and technical training.

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