Site Activation Coordinator

IQVIA•Durham, NC

2d•$35,800 - $91,400

About The Position

Under general supervision, the Site Activation Coordinator performs country-level site activation activities 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 supports assigned studies and investigative sites by preparing and reviewing regulatory and contractual documentation, tracking document progress and approvals, distributing completed documents, and maintaining project systems and tracking tools. Work is performed in coordination with the Site Activation Manager, Project Management team, and other departments as needed.

Requirements

At least 1 year of experience in a healthcare environment, or an equivalent combination of education, training, and experience.
Good interpersonal communication and organizational skills.
Good word processing skills and knowledge of MS Office applications.
Good 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.
Able to work as a productive individual contributor under general supervision and address generally routine problems that may require interpreting procedures or policies.

Nice To Haves

Bachelor's degree in life sciences or a related field (preferred).

Responsibilities

Perform site activation activities for investigative sites in assigned studies according to 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.
Update and maintain 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 Form (ICF) documents, and Investigator Pack (IP) release documents.
Work closely with the Site Activation Manager, Project Management team, and other departments as necessary.