Clinical Research Associate - UK

Location United Kingdom
Contact name: Christopher Blohm

Contact email: christopher.blohm@medella.life
Job ref: 797
Published: 11 months ago

Job Description:

Position Overview: As a Clinical Research Associate (CRA), you will play a vital role in our clinical research team, ensuring the successful planning, execution, and monitoring of clinical trials conducted in the United Kingdom. You will work closely with investigative sites, sponsors, and other stakeholders to ensure compliance with regulatory requirements and study protocols. This position offers an exciting opportunity to contribute to the advancement of medical research and make a real impact on patient care.

Key Responsibilities:

  1. Site Monitoring: Conduct site visits to monitor the progress of clinical trials, ensuring that all activities are conducted in accordance with study protocols, regulatory requirements, and good clinical practice (GCP) guidelines.

  2. Site Management: Build and maintain strong relationships with investigative sites, providing guidance and support throughout the study lifecycle.

  3. Data Verification: Review and verify clinical trial data, ensuring accuracy and completeness, and report any discrepancies or issues to the study team.

  4. Regulatory Compliance: Ensure that all aspects of the clinical trial, including documentation and informed consent processes, adhere to UK regulatory requirements and ethical standards.

  5. Protocol Adherence: Collaborate with study investigators to ensure strict adherence to study protocols, safety assessments, and data collection.

  6. Safety Reporting: Monitor and report adverse events and serious adverse events in compliance with regulatory timelines.

  7. Documentation: Maintain accurate and complete trial documentation, including site visit reports, correspondence, and regulatory submissions.

Qualifications:

  • Bachelor's degree in life sciences or a related field.
  • Previous experience as a Clinical Research Associate in the pharmaceutical, biotechnology, or CRO industry.
  • Strong understanding of UK regulatory requirements and GCP guidelines.
  • Medical Device experience is a must
  • Excellent communication and interpersonal skills.
  • Detail-oriented with strong organisational abilities.
  • Proficiency in using clinical trial management systems and data management tools.
  • Knowledge of electronic data capture (EDC) systems is a plus.

Contract Details:

  • This is a contract position with a duration of 12 month.
  • The position may require travel to investigative sites within the UK.