Project Specialist (Clinical Research)

TL;DR

Project Specialist (Clinical Research): Operational and administrative support for the setup, implementation, and management of Expanded Access Programs (EAPs) with an accent on maintaining electronic trial master files, clinical trial management systems, and coordinating shipments. Focus on reviewing documentation for FDA/GCP/ICH compliance, data entry into CTMS, and supporting project and finance teams.

Location: Morrisville, North Carolina, US / Remote, US

Company

hirify.global partners with sponsors to help patients and physicians gain early access to medicines through Expanded Access Programs, with over 15 years of experience distributing products to 120+ countries worldwide.

What you will do

• Assist with development and execution of EAPs in collaboration with project management team.
• Coordinate shipments of investigational products with supply chain team per SOPs.
• Support filing of vendor invoices and maintain sponsor/site contact lists.
• Communicate with sites for enrollment and maintenance, organize shared documents in OneDrive/SharePoint.
• Collect and review project documentation from sites to ensure FDA/GCP/ICH compliance.
• Prepare IPRFs for regulatory team and maintain eTMF and CTMS data.

Requirements

• Bachelor’s degree (health or science field preferred)
• 1-3 years in project management or clinical research
• Effective verbal and written communication skills
• Proficiency in Microsoft Office and computer literacy
• Strong organizational skills, attention to detail, ability to handle confidential information
• Team player, adaptable, problem solver

Culture & Benefits

• Medical, dental, vision insurance, FSA, HSA
• Voluntary short/long-term disability and life insurance
• 401K safe harbor with company match
• Paid vacation, holidays, sick time, maternity/paternity leave
• Wellness, growth, and team-building initiatives
• Commitment to DEI, equal opportunity employer with accommodations for disabilities