Clinical Research Associate

vor 1 Monat

Köln, Nordrhein-Westfalen, Deutschland Allucent Vollzeit
About the Role

We are seeking a highly skilled and experienced Clinical Research Associate to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for ensuring the smooth execution of clinical trials, from site initiation to close-out.

Key Responsibilities
  • Conduct site initiation, monitoring, and close-out visits to ensure compliance with Good Clinical Practice (GCP) and regulatory requirements.
  • Review and verify site documentation, including informed consent forms, case report forms, and study protocols.
  • Collaborate with site staff to resolve issues and ensure timely completion of study activities.
  • Develop and maintain strong relationships with site investigators, research coordinators, and other stakeholders.
  • Participate in the development and implementation of clinical trial protocols, including study design, patient recruitment, and data management.
  • Contribute to the development and maintenance of clinical trial documentation, including study protocols, informed consent forms, and case report forms.
  • Ensure compliance with regulatory requirements, including ICH-GCP, 21 CFR Part 11, and HIPAA.
  • Participate in the review and approval of clinical trial documentation, including study protocols, informed consent forms, and case report forms.
  • Collaborate with cross-functional teams, including clinical operations, data management, and regulatory affairs.
Requirements
  • At least 5 years of experience in clinical research, including experience in clinical trials management, site monitoring, and regulatory compliance.
  • Relevant life science degree or healthcare background.
  • Strong knowledge of GCP, ICH, and regulatory requirements.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Strong analytical and problem-solving skills.
  • Proficiency in Microsoft Office, including Word, Excel, and PowerPoint.
What We Offer
  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.
  • Recognition and rewards for outstanding performance.

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