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Clinical Research Associate Ii

2+ years
Not Disclosed
10 May 2, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Clinical Research Associate II


Company:

PSI CRO
A global Contract Research Organization with over 30 years of experience. PSI offers a balance of innovation and stability, focusing on quality and on-time delivery across diverse therapeutic areas.


Location:

Remote (Must be based in Western Canada)


Job Type:

Full-time


About the Company:

PSI is a leading global CRO that emphasizes quality and strong client relationships. With a 30+ year legacy, PSI operates with high standards in clinical research, supporting complex studies across multiple therapeutic areas while fostering a stable, innovation-driven culture.


Job Description / Responsibilities:

  • Serve as the main liaison between the project team, sponsor, and site

  • Maintain strong site relationships during study conduct

  • Conduct all types of monitoring visits: selection, initiation, routine, and closeout

  • Ensure subject recruitment goals are set, tracked, and met at site level

  • Monitor adverse events, protocol deviations, and data query resolution

  • Perform source data verification (SDV) and risk review at site level

  • Handle investigational product (IP) and study supply accountability

  • Reconcile and review ISF/TMF documentation

  • Conduct audit preparation, resolve findings, and support client audits

  • Coordinate document and supply flow between the project team and sites

  • Conduct training for investigators and support investigator newsletters

  • Assist with regulatory submissions and IP-RED package collection

  • Reconcile TMF at both site and country levels


Minimum Qualifications:

  • Bachelor’s degree in Life Sciences or equivalent education/experience

  • At least 2 years of independent monitoring experience

  • Full proficiency in English

  • Proficiency in MS Office

  • Must be located in Western Canada

  • Able to travel up to 75%

  • Valid driver’s license (if applicable)


Preferred Qualifications:

  • Experience in all types of monitoring visits (Phases I–III)

  • Oncology monitoring experience highly preferred

  • Strong communication, collaboration, and problem-solving skills

  • Ability to multitask and work in dynamic, fast-paced environments