Regulatory Compliance Specialist

3 dni temu


Warszawa, Mazovia, Polska Comac Medical Pełny etat

Are you a detail-oriented and organized individual with experience in clinical research? Do you have a passion for building and maintaining strong relationships with investigators and site staff? If so, we may have the perfect opportunity for you

About the Job

We are seeking a highly skilled Clinical Research Associate to join our team at Comac Medical. As a critical member of our clinical research department, you will play a key role in ensuring the success of our clinical trials.

Your primary responsibility will be to develop and maintain strong relationships with sites participating in our clinical trials. This involves:

  • Gaining In-Depth Understanding: Develop an in-depth understanding of the study protocol and related procedures to effectively communicate with investigators and site staff.
  • Study Documentation: Prepare study documentation, including draft protocols and CRFs, to ensure accurate and compliant data collection.
  • Regulatory Compliance: Collect, review, and monitor required regulatory documentation to ensure compliance with regulatory requirements.

You will also be responsible for performing remote and on-site monitoring and oversight activities, identifying and assessing site performance, quality, or compliance problems, and escalating these issues as necessary.

Requirements

To succeed in this role, you will need to possess:

  • Strong Communication Skills: Excellent communication and interpersonal skills to build and maintain strong relationships with investigators, site staff, and other stakeholders.
  • Regulatory Knowledge: In-depth knowledge of regulatory requirements and guidelines related to clinical trials.
  • Organizational Skills: Strong organizational and time management skills to prioritize tasks and meet deadlines.

We offer a competitive salary and benefits package to attract and retain top talent. If you are passionate about clinical research and possess the skills and qualifications outlined above, we encourage you to apply.



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