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Senior Clinical Research Specialist

2 months ago

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

Position Overview:

The Senior Clinical Research Specialist plays a pivotal role in overseeing the integrity of data within internal studies. This position collaborates closely with Study Directors to guarantee thorough and prompt data evaluations across all facets of GLP and Preclinical Functionality studies.

Key Responsibilities:

  • Serve as the Primary Data Reviewer for internal research initiatives, ensuring comprehensive data scrutiny of medical and surgical records, protocols, and study findings.
  • Engage with team members to pinpoint, assess, and propose corrective measures for identified discrepancies.
  • Prepare timely reports on study deviations, integrating assessments from the Study Director.
  • Conduct audits of protocols, standard operating procedures (SOPs), and quality system components to confirm adherence to GLP regulations (21 CFR Part 58) and internal policies, maintaining compliance with established quality standards.
  • Ensure compliance with relevant regulations and standards, recognizing fundamental non-compliance issues.
  • Exhibit exceptional attention to detail, with a strong foundation in data management and familiarity with GLP research in the medical device sector.
  • Demonstrate the ability to collaborate effectively across various teams, navigating different locations efficiently 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 pertinent experience supporting preclinical research.
  • Proven knowledge in the operation of calibrated instruments, management of controlled substances, and GLP data collection and retention practices.