Senior Clinical Research Associate

4 weeks ago

Gold Coast, Queensland, Australia Pharmiweb Full time
Job Title: Senior Clinical Research Associate - Cambridge, MA

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 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:
  • 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.
  • Drive the adoption of compliant clinical study execution practices throughout the sponsor's active clinical studies, including research and testing of products involving human beings.
  • Develop and maintain policies and procedures for the Clinical Operations function of Clinical and Medical Affairs.
  • Support, update, and maintain 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.
  • Ensure monitoring plans are created and followed, with monitoring documentation included in the applicable Trial Master Files.
  • 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.
  • Support EDC user acceptance testing and training as applicable.
  • Oversee and support the creation of the trial master file, regulatory binder, source documents, and investigational product ordering, shipping, and associated documentation.
Requirements:
  • 3+ years of clinical monitoring experience.
  • Knowledge of ICH and local regulatory authority regulations regarding drugs.
  • Device experience required.
  • 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 and a range of additional benefits, including various annual leave entitlements, a range of health insurance offerings, competitive retirement planning offerings, and a Global Employee Assistance Programme.

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