Site Activation Specialist

IQVIA•Durham, NC

About The Position

Under moderate supervision, this role executes feasibility, site identification, regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional or country level. The specialist prepares and manages site documentation, reviews and negotiates site documents and contracts with sites and sponsors, maintains, reviews, and reports on site performance metrics, serves as the primary point of contact for investigative sites, tracks completion of appropriate documents for sites, ensures contracts are fully executed, and establishes project timelines. With moderate oversight and supervision, perform tasks at a country/region level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Requirements

Bachelor's Degree Life sciences or a related field
1 - 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
3 years’ experience in a healthcare environment or equivalent combination of education, training and experience.

Responsibilities

Serve as a Single Point of Contact (SPOC) to perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary.
Prepare site documents, reviewing for completeness and accuracy.
Inform team members of completion of regulatory contractual, and other documents for individual sites.
Distribute completed documents to sites and internal project team members.
Update and maintain internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
Review, track and follow up the progress, the approval and execution of required documents such as questionaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents.