Clinical Research Associate II

5 days ago

British Columbia, Canada ICON Strategic Solutions Full time

About ICON Strategic Solutions

We are a leading provider of clinical research services, dedicated to delivering high-quality solutions that meet the evolving needs of our clients. Our team of experts is committed to excellence and innovation, driving the development of new treatments and therapies.

Job Summary

We are seeking a highly skilled Clinical Research Associate II (CRA) to join our team in oncology monitoring. As a CRA, you will be responsible for implementing and managing clinical studies at participating sites, ensuring the quality of site performance, and closing clinical studies. If you have a passion for clinical research and a strong background in oncology monitoring, we encourage you to apply for this exciting opportunity.

Key Responsibilities

  • Evaluate and initiate clinical study sites, documenting all activities in clear and accurate reports within required timelines.
  • Ensure the conduct of clinical studies at sites adheres to protocols, Good Clinical Practice regulations, International Harmonization Guidelines, company SOPs, and applicable regulatory requirements.
  • Properly train and re-train site personnel on protocols, systems used in the study, and operational aspects of the trial.
  • Serve as primary contact for site personnel, acting as liaison between site staff and sponsor study team members.
  • Develop patient recruitment strategies with clinical sites to meet enrollment timelines.
  • Ensure subjects' rights, safety, and well-being are protected.
  • Comply with procedures for adverse events and serious adverse events.
  • Evaluate data quality and integrity, ensuring sites enter data into EDC and resolve queries in a timely fashion.
  • Assist with data validation and cleaning procedures to ensure timelines are met.
  • Identify and resolve site performance, quality, or compliance issues, developing an intervention plan to prevent errors and deviations.
  • Communicate with Investigators, site staff, Sponsor Study Team Members, and/or QA on issues related to protocol conduct, subject recruitment and retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.
  • Maintain audit-ready clinical trial documentation, collecting, reviewing, monitoring, and filing required regulatory documents during study maintenance and at study closeout.
  • Verify investigator study records match contents of Sponsor files (Trial Master File).
  • Ensure availability of study medications and non-clinical materials for sites.
  • Develop strong site relationships, ensuring continuity through all phases of the trial.

Requirements

  • Bachelor's degree in Life Sciences or equivalent, preferably with experience in pharmaceutical/biotechnology industry monitoring.
  • Minimum 2+ years of experience in clinical research monitoring from study start-up to database lock.
  • Strong background in oncology monitoring in phase 1-3 pharmaceutical/biotechnology clinical trials.
  • Good understanding and working knowledge of ICH guidelines, Good Clinical Practices, PhRMA code, FDA CFR, clinical research ethics, HIPAA, and patient privacy laws.
  • Proficiency in EDC, IVRS, and CTMS systems.
  • Possess excellent communication, organizational, analytical, and project management skills.
  • A valid driver's license is required.

Benefits

We offer a competitive salary range of $70,000 - $90,000 per year, depending on experience. Additionally, you will receive a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off. We also offer opportunities for professional growth and development, as well as a dynamic and supportive work environment.

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