Sr Site Activation Specialist

IQVIA•Durham, NC

About The Position

Perform country-level Site Activation (SA) 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. This is a developing professional individual-contributor position working under moderate oversight and supervision. The specialist makes recommendations to enhance systems and processes and address general problems that may require understanding broader issues but are not complex. Under general supervision, the specialist serves as the Single Point of Contact (SPOC) for assigned studies, supporting investigative sites, the Site Activation Manager (SAM), the Project Management team, and other departments. The role supports feasibility, site identification, start-up, site activation, document preparation and quality control, project planning, timeline tracking, and maintenance of project systems and records. It also provides local expertise to SAMs and project teams and may involve direct sponsor contact for specific initiatives.

Requirements

Bachelor's degree in life science or a related field.
Three years of clinical research or other relevant experience, or an equivalent combination of education, training, and experience.
Three years of clinical research experience, including one year in a leadership capacity, or an equivalent combination of education, training, and experience.

Responsibilities

Serve as the Single Point of Contact for investigative sites, the Site Activation Manager, the Project Management team, and other departments on assigned studies.
Ensure adherence to SOPs and Work Instructions, the quality of designated deliverables, and project timelines.
Perform feasibility, site identification, start-up, and site activation activities in accordance with applicable regulations, SOPs, and work instructions.
Distribute completed documents to sites and internal project team members.
Prepare site documents and review them for completeness and accuracy.
Maintain accurate project-specific information in internal systems, databases, and tracking tools.
Review site performance metrics and provide feedback to management.
Review, establish, and agree on project plans and timelines; ensure monitoring measures are in place and implement contingency plans as needed.
Inform team members when feasibility, site identification, regulatory, and contractual documents are complete for individual sites.
Review, track, and follow up on the progress, approval, and execution of documents and questionnaires, including CDA/SIF, regulatory and ethics documents, Informed Consent Forms, and Investigator Pack release documents, in line with project timelines.
Provide local expertise to Site Activation Managers and project teams during initial and ongoing project timeline planning.
Perform quality control of documents provided by sites.
May have direct contact with sponsors on specific initiatives.
Make recommendations for improvements to systems and processes.