Clinical Research Specialist - Remote

Overview

The Clinical Research Specialist is responsible for performance and compliance for assigned protocols and sites, ensuring adherence to regulations and quality standards throughout the clinical research process.

In Short

• Accountable for compliance of study conduct with ICH/GCP and local regulations.
• Acts as primary site contact and site manager throughout clinical research phases.
• Develops and maintains strong relationships with clinical sites.
• Performs remote and on-site monitoring activities.
• Coordinates tasks with other sponsor roles for site readiness.
• Conducts various site visits and monitors regulatory documentation.
• Communicates with investigators regarding protocol conduct and site performance.
• Identifies and resolves site performance issues.
• Contributes to the identification of new potential research sites.
• Supports audit and inspection activities as needed.

Requirements

• Experience in clinical research and site management.
• Knowledge of ICH/GCP guidelines.
• Strong communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Detail-oriented with strong organizational skills.
• Experience with regulatory documentation and compliance.
• Proficient in data management systems.
• Ability to travel as necessary for site visits.
• Strong problem-solving skills.
• Ability to mentor and support junior staff.

Benefits

• Competitive salary and benefits package.
• Opportunity to work in a leading healthcare organization.
• Professional development and training opportunities.
• Flexible work arrangements.
• Collaborative work environment.
• Access to cutting-edge research and technology.
• Supportive management and team structure.
• Health and wellness programs.
• Employee recognition programs.
• Contributions to community health initiatives.