Clinical Advisor

2 weeks ago

Rockville, United States GAP Solutions, Inc. Full time

Position Objective: Provide services as a Clinical Advisor in support of the overall functions of the Division of AIDS, Office of Clinical Site Oversite (OCSO), Asia and the Americas Branch (AAB) within the National Institute of Allergy and Infectious Diseases (NIAID).




Duties and Responsibilities:

  • Implement and coordinate a range of individual clinical site-management activities.
  • Advise PIs on clinical site start-up and relevant operational and regulatory issues including resource allocation, and administrative issues.
  • Provide leadership for planning, organizing, and conducting site visits or reverse site visits as appropriate to clinical trials units/clinical research sites to effectively fulfill site management responsibilities.
  • Assess the level of clinical trials research competency of clinical research sites and the extent of research knowledge and technology available to achieve the desired quantity and quality results for the clinical research trials being conducted.
  • Evaluate clinical trials units/clinical research sites’ organizational structures and modes of operations in relationship to the achievement of the Division’s goals and objectives in the areas of administration, clinical site management, and recruitment of patients.
  • Provide oversight and technical direction for evaluation of site performance.
  • Identify problems or issues that transcend individual units or trends that indicate the need for procedural clarification or policy development and recommends follow-up actions or policy directives to OCSO Director or Branch Chief.
  • Conduct trainings at sites and Network meetings on relevant policies/regulations.
  • Attend Network meetings, conference calls, ad hoc meetings and working groups.
  • Support federal Program Officers by: 1) tracking and summarizing grantee compliance with training requirements, grantee progress in meeting the grant aims by reviewing progress reports, and adherence to applicable regulations; and 2) reviewing and providing input on training materials, policies and procedures.
  • Participate in the creation and review of site development and site closure-related documents and checklists.
  • Interface with networks, investigators, Operations Centers, to share information and collaborate on research and site-related issues.
  • Prepare oral and written presentations for internal and external programmatic and scientific meetings.




Basic Qualifications:

  • Minimum of a BS degree in a science or health related discipline.
  • Progressive experience in managing clinical trials/clinical research sites and/or monitoring clinical trials, with a minimum of 3 years experience in clinical research.




Minimum Qualifications:

  • Ability to communicate effectively, orally and in writing, with non-technical and technical staff.
  • Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects

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