Site Activation Coordinator

IQVIA•Durham, NC

About The Position

Under general supervision, the Site Activation Coordinator performs country-level site activation activities for investigative sites in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and contractual and budgetary guidelines. The role may also include maintenance activities. The coordinator works closely with the Site Activation Manager, Project Management team, and other departments to support assigned studies. The position requires reviewing and preparing site regulatory documents, coordinating their distribution and completion, and maintaining accurate project information and document tracking.

Requirements

  • Bachelor's degree in life sciences or a related field.
  • Good interpersonal communication and organizational skills.
  • Good word-processing skills and knowledge of MS Office applications.
  • Strong attention to detail.
  • General awareness of the clinical trial environment and drug development process.
  • Ability to work on multiple projects.
  • Ability to establish and maintain effective working relationships with co-workers, managers, and sponsors.

Nice To Haves

  • One year of experience in a healthcare environment, or an equivalent combination of education, training, and experience.

Responsibilities

  • Perform site activation activities for investigative sites in assigned studies, following applicable regulations, SOPs, and work instructions.
  • Review documents for completeness, consistency, and accuracy under the guidance of senior staff.
  • Prepare site regulatory documents and review them for completeness and accuracy.
  • Inform team members when regulatory and contractual documents for individual sites are complete.
  • Distribute completed documents to sites and internal project team members.
  • Support updates and maintenance of internal systems, databases, tracking tools, timelines, and project plans with accurate, complete project-specific information.
  • Review, track, and follow up on the progress, approval, and execution of regulatory and ethics documents, Informed Consent Forms (ICFs), and Investigator Pack (IP) release documents.

Benefits

  • A range of health and welfare benefits may be offered, depending on the position.
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