Non-IT

Research Regulatory Specialist

Contract

Medasource

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Position: Research Regulatory Specialist

Location: Nashville, TN, some remote capabilities available

Start Date: ASAP

End Date: 6 months contract-to-hire

JOB SUMMARY

The REsearch Regulatory Specialist will prepare and submit protocols and supporting documents to regulatory bodies such as the Institutional Review Board (IRB). This role submits continuations, amendments, responds to questions, generates reports, and maintains research files and documentation involving the regulatory requirements for the study/clinical trial. Other duties include, representing the Cancer Center when meeting with pharmaceutical companies, attending weekly team meetings, and working with other staff to insure all regulatory documents and requirements are met and up-to-date. May plan and coordinate strategies for improving efficiency, action plan to improve quality or training and education of personnel. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local IRB.

KEY RESPONSIBILITIES

  • Advanced knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporates them in the conduct of research (e.g., FDA, OHRP, GCP/ICH guidelines, and HIPAA regulations)
  • Advanced knowledge and understanding of the management and implementation of clinical/translational research operations
  • Assesses for and implements process improvement initiatives within the department to assure research quality
  • Read and follow protocols and other study-related documents

Medasource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.

JO-2106-112021

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