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Title

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Clinical Research Associate

Description

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We are looking for a Clinical Research Associate to join our team and play a pivotal role in the execution and monitoring of clinical trials. As a Clinical Research Associate, you will ensure that clinical studies are conducted in compliance with regulatory requirements, protocols, and ethical standards. You will act as a liaison between the sponsor and the clinical trial sites, ensuring the integrity of data and the safety of participants. This role requires a detail-oriented professional with strong organizational skills and a passion for advancing medical research. Your primary responsibilities will include monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. You will be responsible for verifying that data collected is accurate, complete, and verifiable against source documents. Additionally, you will assist in the preparation of study-related documentation, including protocols, case report forms, and informed consent documents. The ideal candidate will have a strong background in life sciences or a related field, with prior experience in clinical research. You should possess excellent communication skills, as you will be required to interact with investigators, site staff, and other stakeholders. Attention to detail and the ability to manage multiple tasks simultaneously are essential for success in this role. This position offers an exciting opportunity to contribute to groundbreaking medical research and improve patient outcomes. If you are passionate about clinical research and have the qualifications and experience required, we encourage you to apply.

Responsibilities

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  • Monitor clinical trial sites to ensure compliance with protocols and regulations.
  • Verify accuracy and completeness of data collected during trials.
  • Assist in the preparation of study-related documentation.
  • Act as a liaison between sponsors and clinical trial sites.
  • Ensure the safety and well-being of trial participants.
  • Conduct site initiation, monitoring, and close-out visits.
  • Provide training and support to site staff as needed.
  • Prepare and submit monitoring reports in a timely manner.

Requirements

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  • Bachelor's degree in life sciences, nursing, or a related field.
  • Prior experience in clinical research or a similar role.
  • Strong knowledge of Good Clinical Practice (GCP) guidelines.
  • Excellent organizational and time-management skills.
  • Attention to detail and ability to handle multiple tasks.
  • Strong communication and interpersonal skills.
  • Proficiency in Microsoft Office and clinical trial management systems.
  • Willingness to travel as required for site visits.

Potential interview questions

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  • Can you describe your experience with clinical trial monitoring?
  • How do you ensure compliance with Good Clinical Practice (GCP) guidelines?
  • What strategies do you use to manage multiple tasks and deadlines?
  • Have you ever encountered a compliance issue during a trial? How did you handle it?
  • What experience do you have with clinical trial management systems?