Appel à manifestation d’intérêt : FHI recrute un(e) Spécialiste de projet aux Etats-Unis.

 

 

 

 

 

 

Summary of the Position:

The Project Specialist I assist the project management team in the implementation of clinical trials. Responsible for the collection, review, tracking, maintenance, and archiving of essential study documents in the Trial Master File (TMF), ensuring that project-specific administrative documents (e.g., contact lists, etc.) are maintained. May be responsible for assisting in the management of individual, large, or complex studies/programs. Assists the project management teams in ensuring the most effective and efficient conduct of clinical research studies by providing administration and project tracking support. Key role in supporting project team needs.

Essential Functions:

  • Supports project teams by performing tasks related to study management from start-up to study completion.
  • Provides administrative support to the project team and works closely with the project management team.

  • Assists the project management team with written and verbal communications with study staff.

  • Assists the project management team with the creation of study-specific documents and materials. (including but not limited to team lists, authorization lists for study-specific systems, tracker reports, etc.)
  • Utilizes technology effectively to support clinical development processes; develops mastery of relevant systems (e.g. study management tools) and identifies new innovative ideas and shares best practices.
  • Ensure and track that all project team members have completed project-specific training.
  • Prepares and issues meeting minutes, including action items, under the direction of project management.
  • Maintains the study-specific TMF and associated electronic archives by uploading and completing monthly QC reviews of study-specific documents.
  • Responsible for the organization of meetings (both internal and external) under the direction of the project team.
  • Assists in the close-out of projects by performing a final Quality Control (QC) of the TMF, identifying items and issues for review and/or follow-up by the CRAs and/or project management.
  • Assist in the production of slides, overheads, etc. as needed for department, project, and sponsor and or business development.

  • Prepared documents for kick-off meetings and investigator meetings. Could attend the meetings to provide administrative support.

  • Performs other duties as assigned by the project manager.

Knowledge, Skills and Abilities:

  • Needs a basic understanding of the conduct of clinical trials, related systems, and procedures, and guidance and regulations.

  • Ability to write clearly and succinctly; must have demonstrated ability to accurately record meeting minutes and action items.
  • Must have excellent interpersonal and communication skills and demonstrate the ability to work successfully in a team environment.
  • Ability to prioritize and manage multiple tasks.
  • Familiar with applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Proficiency in Microsoft Office, spreadsheet software, and other technology required.
  • Articulate, professional, and able to communicate in a clear, positive fashion with clients and staff.
  • Demonstrate effective organizational skills.

  • Demonstrate strong attention to detail.

  • Must be able to read, write and speak fluent English.

Position Requirements:

  • Education: Bachelor’s degree, or its international equivalent. Preferably in Health, Behavioral, Life Science. In lieu of degree, equivalent combination of education, training, and relevant work experience.

  • Preferred Job-related Experience: Typically requires a minimum of 0 – 1 years’ experience in clinical research, other researcher healthcare-related fields. Preferred Education and/or Experience: Related prior work experience preferred. Prior work in a non-governmental organization (NGO). Non-governmental organization (NGO) experience preferred

  • Special Position Requirements: Technology to be used: Personal Computer, Microsoft Office 365 (i.e. Word, Excel, PowerPoint, e-mail), office telephone, cell phone, and printer/copier.

Application deadline : February 28th, 2023

Apply here