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Clinical Research Lead

3 weeks ago

Toronto, Ontario, Canada Pharmaceutical Research Associates, Inc Full time

Overview

We are seeking a skilled Clinical Research Associate to join our team at Pharmaceutical Research Associates, Inc.

Key Responsibilities:

  • Lead the execution of multiple oncology trials with high-quality oversight
  • Provide leadership and mentorship to junior team members in clinical trial management
  • Act as a subject matter expert, training and guiding Site Managers on study protocols
  • Develop essential study start-up documents, including SIV agendas
  • Represent Site Managers and Lead Trial Managers in key meetings
  • Ensure the Site Manager perspective is reflected in study documents like Monitoring Guidelines
  • Review reports (SQV, SMV, SCV) for sites assigned to other Site Managers within the same trial
  • Support country budget development and contract negotiations in collaboration with CCS colleagues
  • Maintain compliance with Metrics/KPIs as outlined in the Quality Oversight Plan (QOP)

Qualifications:

  • Minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences
  • At least 2 years of experience monitoring clinical trials in the pharmaceutical industry
  • Experience in multiple therapeutic areas is an asset, particularly in oncology (Hematology, Prostate Cancer, Lung Cancer, Early Development - Phase 1)
  • Knowledge of risk-based/analytical monitoring approaches is an asset
  • Proficiency in clinical trial systems such as CTMS, EDC, TMF, IWRS, and safety reporting tools
  • Ability to actively drive patient recruitment strategies at assigned sites
  • Strong collaboration with investigators and site staff to meet study timelines
  • Effective communication and influencing skills to manage study sites effectively, both remotely and in-person
  • In-depth understanding of Good Clinical Practice (GCP), ICH guidelines, and local regulatory requirements
  • Up to 50% regional travel required