FSP Regulatory & Start Up Specialist 2

Location: Durham, North Carolina, United States of America

Salary: $60,300–$157,100 annualized base pay

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Serve as the single point of contact for investigative sites, Site Activation Managers, project management, and other departments.
• Perform country-level start-up and site activation activities in accordance with regulations, SOPs, work instructions, and project requirements.
• Prepare, distribute, review, track, and follow up on regulatory, ethics, informed consent, investigator pack, and contractual documents.
• Maintain clinical systems, databases, tracking tools, project plans, timelines, and site performance metrics.
• Provide local regulatory expertise, perform document quality control, and implement contingency plans when required.
• Communicate with project teams, managers, sites, and sponsors regarding document completion and study progress.

Requirements

• Bachelor’s degree in life sciences or a related field and 3 years of clinical research or relevant experience, or an equivalent combination of education, training, and experience.
• At least 3 years of clinical research experience, including 1 year in a leadership capacity.
• In-depth knowledge of clinical systems, procedures, corporate standards, and regulated clinical trial environments.
• Knowledge of GCP/ICH and applicable local and international regulatory requirements.
• Strong communication, negotiation, organizational, prioritization, and interpersonal skills.
• Ability to work independently, manage multiple projects, and maintain effective relationships with coworkers, managers, clients, and sponsors.

Culture & Benefits

• Full-time employment with health and welfare benefits.
• Potential incentive plans, bonuses, and other compensation may be available depending on the position.
• Equal opportunity employment environment.