ORAU has a contingent job opportunity for a Clinical Advisor in support of the overall functions of the Clinical Trials Program, National Institute of Health (NIH), located in Bethesda, MD. 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:

• Oversee all aspects of the VRC CTP Pharmacovigilance Program, which leads the process for safety signal management activities, and ensure the detection, assessment, understanding and prevention of safety events for each investigational product (IP) the VRC manufactures for clinical research.
• Provide tactical leadership for the VRC CTP Pharmacovigilance Program/Team.
• Create and adapt pharmacovigilance procedures based on prevailing domestic and international regulations, VRC polices/procedures, etc.
• Review safety events for completeness and trends; analyze comprehensive safety data in consultation with PV team; communicate findings to VRC’s Office of Regulatory Sciences.
• Participate on cross functional, multidisciplinary teams and contribute to defining aggregate reporting guidelines.
• Draft, review and finalize PV data agreements with collaborators who receive VRC-manufactured investigational products.
• Work with VRC’s external partners to gather PV information/data and review it utilizing the PV data system platform (ARGUS).
• Author/provide strategic input or oversight for PV related sections of periodic regulatory documents (i.e. IND annual reports, DSURs, IB updates) according to the agreed process and timelines.
• Monitor and evaluate safety profiles of VRC manufactured investigational products to detect any change in risk profile.
• Collaborate with VRC CTP protocol operations, medical, quality and risk management teams to ensure coordinated and effective risk mitigation strategies throughout the product lifecycle.
• Assign projects and set deadlines for PV Team staff and facilitate PV team meetings.
• Maintain knowledge of vaccine and monoclonal antibody safety profiles and product development status; review relevant biomedical literature or other scientific data.
• Assess GCP compliance risk areas and develop and implement risk mitigation measures, including facilitating Root Cause Analyses (RCAs) and instituting Corrective and Preventive Actions (CAPAs).
• Provide expertise and guidance on governmental regulations, agency guidelines, and internal policies to assure GCP compliance.
• Plan and lead GCP sponsor audits of international and domestic clinical sites, contract clinical laboratories, and Contract Research Organizations (CROs) to verify and document compliance status and identify any compliance risks.
• Conduct Trial Master File (TMF) audits.
• Facilitate and track GCP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies.
• Participate as a Subject Matter Expert in the evaluation and selection of CROs and other clinical and nonclinical service providers supporting CTP activities.
• Develop and implement SOPs, policies and work instructions for GCP regulatory compliance.
• Identify and seek appropriate resources for the functioning and improvement of the QMS.
• Work with CTP leadership team and personnel on issues that require resolution or escalation.

• 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.
• Clinical Advanced degree (NP, PA, MD, etc.)
• Minimum 3 -5 years’ experience in PV with significant experience in preparing regulatory documents.
• Knowledge of clinical trial and PV methodologies including safety profile and risk/benefit analysis and detailed comprehension of global regulatory requirements in PV.
• Experience with MedDRA and drug coding reviews.
• 5 to 10 years’ related experience in a biotechnology, pharmaceutical company, government, or CRO environment.
• Strong experience in the conduct and management of clinical trials, especially phase I – III vaccine or monoclonal antibody clinical trials. Strong background in clinical trial drug safety is required.
• Must have thorough understanding of medical terminology and ability to summarize medical information.
• Personnel management and supervisory experience.
• Strong attention to detail and follow-up skills.
• Must be flexible and willing to take on significant administrative responsibilities.
• Must take initiative and have ability to work independently and as a team member, offering assistance wherever needed.
• Must be able to create contingency plans to deal with possible challenges and roadblocks.
• Good computer and database skills, familiarity with ARGUS platform is a plus.

• 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 )