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Senior Clinical Research Associate

1 month ago

Brisbane, Queensland, Australia Pharmiweb Full time

Job Summary

We are seeking a highly skilled Senior Clinical Research Associate to join our team in Cambridge, MA. As a Senior CRA, you will be responsible for monitoring the progress of clinical studies at investigative sites or remotely, ensuring that clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

Key Responsibilities

  • Monitor the progress of clinical studies at investigative sites or remotely
  • Ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, SOPs, ICH-GCP, and all applicable regulatory requirements
  • Provide leadership in the execution of clinical studies to deliver high-quality data to support sponsors on time, within budget, and in compliance with all applicable regulations and procedures
  • Develop and maintain policies and procedures for the Clinical Operations function of Clinical and Medical Affairs
  • Support the Clinical Trial Management System application for clinical study execution and reporting
  • Ensure clinical studies are conducted according to procedures, including up-to-date and complete trial master files, regular review of data, and assurance that monitoring reports are completed within two weeks of visit date
  • Act as Clinical Study Manager for designated clinical studies under the guidance of your Manager and may support other studies in this role as applicable
  • Attend all required meetings and provide updates to the team

Requirements

  • 3+ years of clinical monitoring experience
  • Knowledge of ICH and local regulatory authority regulations regarding drug and device experience
  • Experience in using EDC and CTMS systems is desirable
  • Knowledge of Sharepoint and Excel is helpful in this role
  • Experience with direct line management of staff, including hiring, training, oversight, and mentoring
  • Good command of written and spoken English language
  • Excellent verbal and written communications skills
  • Excellent interpersonal and organizational skills
  • A pro-active, committed, and motivated attitude
  • A demonstrated working knowledge of GCP, ICH guidelines, ISO Standards, FDA/EU regulations
  • Ability to work very accurately and thoroughly
  • Excellent record-keeping skills; good documentation practice
  • Ability to maintain excellent working relationships with a broad range of clinical study staff
  • Ability to work well in a team environment but also independently without significant oversight
  • Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines
  • Flexibility in work hours and readiness to travel

What We Offer

We offer a competitive salary, a range of health insurance offerings, competitive retirement planning, and a Global Employee Assistance Programme. We are committed to providing an inclusive and accessible environment for all candidates and employees.