Clinical Research Associate II

4 days ago


British Columbia, Canada ICON Strategic Solutions Full time

Job Summary

We are seeking a highly skilled Clinical Research Associate II with extensive experience in Oncology monitoring to join our team at ICON Strategic Solutions. This is an excellent opportunity for a motivated and organized individual to work on complex clinical trials and contribute to the delivery of high-quality results.

About the Role

The successful candidate will be responsible for evaluating, initiating, and managing clinical study sites, ensuring compliance with regulatory requirements and Good Clinical Practices. The role will involve conducting site visits, training site personnel, and resolving any issues that may arise during the trial. Additionally, the CRA II will develop patient recruitment strategies, ensure data quality, and maintain accurate records.

Key Responsibilities

  • Evaluate clinical study sites to determine their suitability for participation in trials
  • Initiate and manage clinical studies at participating sites, ensuring compliance with protocols and regulations
  • Conduct regular site visits to monitor the conduct of clinical studies and identify any issues
  • Train site personnel on protocol procedures and systems used in the study
  • Develop patient recruitment strategies to meet enrollment timelines
  • Ensure data quality by evaluating reported data and resolving any queries or discrepancies
  • Maintain accurate records of site visits, training sessions, and other relevant activities
  • Collaborate with the clinical site team to ensure smooth trial execution and resolution of any issues

Requirements

  • Bachelor's degree in Life Sciences or related field; RN also accepted
  • Minimum 2+ years of experience as a Clinical Research Associate in the pharmaceutical/biotechnology industry
  • Strong Oncology monitoring experience in phase 1-3 clinical trials
  • Good understanding of ICH guidelines, GCP, PhRMA code, FDA CFR, and other relevant regulatory requirements
  • Proficiency in EDC, IVRS, and CTMS systems; Microsoft Office skills also required
  • Ability to work effectively in a team environment and prioritize multiple studies and projects
  • Demonstrated strengths in planning, organizational, project management, analytical, oral and written communication, time management, conflict management, problem-solving, attention to detail, and interpersonal skills

Compensation

The estimated salary for this position is $$80,000-$110,000 per annum, depending on experience and qualifications. This includes a comprehensive benefits package, including health insurance, retirement plan, and paid time off.

About ICON Strategic Solutions

ICON Strategic Solutions is a leading provider of clinical research services, offering a range of solutions to support the delivery of high-quality clinical trials. Our team of experts has extensive experience in Oncology monitoring and is committed to providing exceptional service to our clients.



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