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Senior Clinical Research Specialist

2 months ago

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

Position Overview:

The Clinical Research Scientist will play a pivotal role in ensuring the integrity and compliance of preclinical studies. This position requires a meticulous approach to data evaluation and collaboration with various stakeholders.

Key Responsibilities:

  • Serve as the Primary Data Reviewer for internal research initiatives, collaborating closely with Study Directors to guarantee thorough and prompt data assessments across all GLP and Preclinical Functionality studies.
  • Engage with team members to pinpoint, assess, and propose corrective measures for identified discrepancies.
  • Prepare and submit timely study deviation reports, integrating impact assessments from the Study Director.
  • Conduct audits of protocols, Standard Operating Procedures (SOPs), and quality system components to ensure adherence to GLP regulations (21 CFR Part 58) and internal protocols, while upholding internal quality standards.
  • Ensure compliance with applicable regulations and standards, identifying fundamental non-compliance issues.
  • Exhibit exceptional attention to detail, a solid foundation in data management, and familiarity with GLP research pertaining to medical devices.
  • Demonstrate the ability to collaborate effectively across diverse teams, efficiently navigating various locations while accommodating stakeholder schedules.

Qualifications:

  • A Bachelor’s degree coupled with a minimum of 3 years of experience in preclinical medical device research, or 5 years of relevant experience supporting preclinical research (such as LAR/surgical veterinary technology).
  • Proven knowledge in the operation of calibrated instruments, management of controlled substances, and GLP data collection and retention practices.