ORAU has a contingent job opportunity for a Clinical Advisor in support of the overall functions of the Safety and Pharmacovigilance Team in the Office for Policy in Clinical Research Operations, Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID). The positions are contingent on award of an upcoming contract with NIAID Professional, Scientific and Technical Support Services. Salary for positions will be determined based on education and experience. Relocation support is not available for this position.

ORAU has been providing scientific and technical talent staffing solutions and designing, managing, and evaluating jobs and internships for more than 70 years. ORAU assists in connecting the best and most diverse group of students, recent graduates, faculty and professionals with world-class fellowships, internships and job opportunities, whether in national laboratories, research institutions, federal government offices or private sector R&D departments.

Technical Requirements:

• Ensure the most current domestic and international regulatory safety reporting requirements are used (e.g., ICH guidelines, FDA, EU and other national and international requirements).
• Provide expert scientific and safety-related expertise to medical officers, study teams, and site investigators to include reviewing and providing comments to DAIDS medical officers on protocols and working with DAIDS medical officers to develop risk management/safety monitoring plans, as needed, for DAIDS-supported studies.
• Serve as a subject matter expert on the safety reporting needed for new Clinical Trial Agreements, safety data exchange agreements, clinical materials transfer agreements and Communication plans
• Provide Expedited Adverse Event (EAE) reporting and safety management expertise and related safety support functions to include serving as a point of contact with project officers, contractors, grantees and intramural staff participating in both domestic and international studies and supporting the DAIDS Adverse Experience Reporting System (DAERS).
• Provide MedDRA coding expertise and support MedDRA-related activities.
• Develop and/or review a variety of safety-related documents and training materials for use by DAIDS, its CROs and partners (e.g., policies, procedures, work instructions, guidance, and training materials related to safety monitoring and reporting requirements for DAIDS-sponsored clinical trials).
• Provide advice in matters related to safety and pharmacovigilance which includes developing pharmacovigilance practices such as set-up and configuration of the safety database, signal detection, trend analysis, analysis of aggregate safety and adverse event data to identify safety concerns in Division-supported clinical trials and provide expertise in preparing reports related to the manufacturing of investigational products such as development safety update reports (DSUR).

• All support positions required a minimum of a BS degree; some require a MS, MD, or Ph.D.
• The education, skills and relevant years of experience required for each support position are consistent with those identified as the minimum requirements for the labor categories specified in the contract.

   

• Degree: Bachelor's Degree, Master's Degree, or Doctoral Degree.
• Discipline(s):
  • Communications and Graphics Design (1 )
  • Environmental and Marine Sciences (1 )
  • Life Health and Medical Sciences (45 )
  • Other Non-Science & Engineering (5 )
  • Social and Behavioral Sciences (28 )