Clinical Operations Specialist

16 hours ago


Melbourne, Victoria, Australia Thermo Fisher Scientific Full time
About the Role

We are seeking a highly skilled Clinical Operations Specialist to join our team at Thermo Fisher Scientific. As a key member of our Clinical Operations team, you will play a critical role in ensuring the successful execution of clinical trials.

Key Responsibilities
  • Monitor investigator sites with a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving skills to identify site processes failures and corrective/preventive actions.
  • Assess investigational product through physical inventory and records review.
  • Raise observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
  • Maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that identified issues are being resolved, and that the data is being recorded.
  • Participate in investigator meetings and initiate clinical trial sites to ensure compliance.
  • Perform trial close-out and retrieval of trial materials, conducting on-site file reviews.
Requirements
  • Bachelor's degree in a life sciences-related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification.
  • Minimal clinical monitoring experience (comparable to 2 years) in a clinical environment where experience is gained in clinical trials may be considered.
  • Valid driver's license.
What We Offer

As a Clinical Operations Specialist at Thermo Fisher Scientific, you will have the opportunity to work on a wide range of clinical trials, collaborating with cross-functional teams to ensure the successful execution of studies. You will also have access to ongoing training and development opportunities to enhance your skills and knowledge.

We value the health and well-being of our employees and support individuals in creating a healthy and balanced environment where they can thrive. This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains. Overnight travel may be required, dependent on business needs.

Please note that as a condition of employment with PPD, you must have received your Covid-19 vaccine and disclose proof of your vaccination status upon employment.



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