Clinical Research Lead

2 weeks ago


Durham, North Carolina, United States Indotronix Avani Group Full time

Position Overview:

The Clinical Research Scientist plays a pivotal role in overseeing the integrity and accuracy of data within preclinical studies. This position is essential for ensuring compliance with Good Laboratory Practice (GLP) standards and facilitating high-quality research outcomes.

Key Responsibilities:

  • Serve as the Primary Data Reviewer for internal research projects, collaborating closely with Study Directors to guarantee thorough and prompt evaluations of all data related to GLP and preclinical studies.
  • Work in partnership with team members to pinpoint, assess, and propose corrective actions for identified discrepancies.
  • Prepare and submit detailed study deviation reports, incorporating assessments of their impact as determined by the Study Director.
  • Conduct comprehensive audits of protocols, standard operating procedures (SOPs), and quality system components to ensure compliance with GLP regulations (21 CFR Part 58) and internal quality standards.
  • Maintain adherence to regulatory requirements and industry standards, identifying instances of non-compliance as necessary.
  • Exhibit exceptional attention to detail, along with a solid foundation in data management and familiarity with GLP research related to medical devices.
  • Demonstrate the ability to work collaboratively across various teams, efficiently navigating different locations while aligning with stakeholder schedules.

Qualifications:

  • A Bachelor’s degree coupled with a minimum of 3 years of experience in preclinical medical device research, or alternatively, 5 years of relevant experience supporting preclinical research (such as LAR or surgical veterinary technology).
  • Proven expertise in utilizing calibrated instruments, managing controlled substances, and adhering to GLP data collection and retention protocols.


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