In Vivo Study Monitor

4 weeks ago

Thousand Oaks, United States Kelly Science, Engineering, Technology & Telecom Full time

In Vivo Study Monitor

Kelly® Science & Clinical is seeking In Vivo Study Monitor for a position at a Biotech company in Thousand Oaks, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay Rate:

$40+/hr Depending on experience

Contract to Hire

Your responsibilities include, but are not limited to:

  • Support future growth activities e.g. laboratory capabilities and in-house nonclinical study conduct
  • Manage study achievements and metrics to ensure delivery to corporate milestones.
  • Interact with CROs for any study-related issues. Make the initial determination of the impact of the issue on the integrity of the study.
  • Coordinate and monitor the internal review of study data to assure compliance with study timelines.
  • Compile all report comments and assure they are conveyed to the Study Director at the CRO
  • Responsible for assisting in the management of all aspects of the studies, including data quality and integrity, efficiency, and regulatory compliance in the execution of study protocols.
  • Study request for resources, study calendar preparation, and scheduling pre-study meetings.
  • Prepare study specific in-life forms, labels, and memos.
  • Extracts and analyzes data for completeness and quality.
  • Monitors study compliance and maintains a system of effective data flow as defined in the study protocols; Serves as a bridge between CRO and the Study Director.
  • Develops, coordinates, and reviews research study procedures to ensure receipt, completeness, and accuracy of research data required for studies.
  • Ensures study documents are complete and stored appropriately.
  • Participates in data retrieval, reporting, and preparation of files and report forms for various aspects of studies as well as entering data into databases.
  • Responsible for assisting the Study Director in the reporting of protocol/ SOP deviations and responding to Study Audits and findings.
  • Participates in study team activities such as project meetings, communications, report generation, etc.
  • Assists in the development and preparation of study reports including tables and figures.
  • Performs proofreading on study reports
  • Assist in the writing of research proposals including grant applications.

Qualifications:

  • Bachelor’s, Master’s, or PhD degree in biology, Animal Sciences, Toxicology or a related field
  • 3 or more years of experience in relevant industry setting
  • Experience in animal husbandry/in-vivo study conduct within Toxicology
  • Project management experience strongly preferred
  • Expertise in management of nonclinical safety assessment study conduct, including the fundamentals of Good Laboratory Practices (GLP) and data interpretation of nonclinical studies

Who You Are:

  • Excellent communication skills (written and oral)
  • Attention to detail and ability to multitask
  • Good understanding of scientific principles and design of scientific studies
  • Strong teamwork skills with internal and external partners

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