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Clinical Advisor (TMFs)

Company: GAP Solutions Inc
Location: Rockville
Posted on: January 21, 2023

Job Description:

Position Objective: Provide services as a Clinical Advisor in support of the overall functions of the Division of AIDS (DAIDS), Office for Policy in Clinical Research Operations (OPCRO) within the National Institute of Allergy and Infectious Diseases (NIAID). Duties and Responsibilities:

  • Assist with the development, implementation, and maintenance of the DAIDS Trial Master Files (TMFs) to meet regulatory requirements.
  • Provide support and guidance to various functional areas supporting the DAIDS TMFs.
  • Provide support of DAIDS TMF operations during eTMF implementation, audits, and/or regulatory inspections.
  • Ensure TMFs are inspection ready at all times and TMF documents are filed contemporaneously in a timely manner.
  • Monitor and identify study trends, communicate issues, and escalate concerns to the federal client.
  • Liaise with various functional area leads to reconcile TMF documents which have been received to ensure completeness and quality of files.
  • Ensure compliance with ICH, U.S. federal regulations, and DAIDS policies and procedures.
  • Assist in the tracking of all TMF activities (essential document submission and status).
  • Participate in working groups and team meetings, as required.
  • Develop SOPs as required to ensure oversight of the DAIDS TMF process
  • Provide guidance and consultation on regulations, policies and procedures to DAIDS staff and collaborators. Basic Qualifications:
  • Minimum of a MS/MA in natural sciences.
  • At least 3-5 years of experience in positions of increasing responsibility in clinical operations, TMF or essential documents management.
  • Solid understanding of global ICH GCP requirements, including the recent updates.
  • Solid understanding of trial master files organization, implementation and archival including other relevant regulations and guidance to assure quality of TMFs.
  • Ability to anticipate and resolve problems effectively, experience implementing TMFs. Minimum Qualifications:
  • Prior regulatory inspection experience a plus.
  • Good written and oral communication skills.
  • Strong interpersonal capabilities and ability to build and maintain networks.
  • Strong verbal communication and technical writing skills .
  • 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. *This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned. GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics. This position is contingent upon contract award. Requisition ID: 5631

Keywords: GAP Solutions Inc, Rockville , Clinical Advisor (TMFs), Healthcare , Rockville, Maryland

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