Clinical Research Specialist

Overview

• Serve as a Clinical Research Specialist on a two-year contract, contributing to impactful clinical studies and research initiatives.
• Collaborate with cross-functional teams to oversee clinical trial operations and ensure compliance with regulatory standards.
• Utilize your expertise in site management and clinical trial systems to drive project success.
• Prepare and author protocols, patient record forms, and study documentation adhering to Good Clinical Practice (GCP).
• Contribute to the design, planning, and development of clinical evaluation research studies.
• Interpret clinical investigation results for new drug, device, or consumer applications.
• Work on-site in a dynamic environment, collaborating with stakeholders to achieve project milestones.
• Opportunity to convert to a permanent position based on performance and organizational needs.

Key Responsibilities & Duties

• Oversee and resolve operational aspects of clinical trials, ensuring adherence to SOPs and regulatory requirements.
• Prepare clinical trial budgets and manage clinical supply operations effectively.
• Select and coordinate with sites and vendors to optimize trial execution.
• Mentor junior professionals and provide guidance to support their development.
• Communicate with internal and external contacts to share information and support decision-making processes.
• Apply specialized knowledge and skills to deliver and oversee projects from design to implementation.
• Contribute to innovation and process enhancements to improve job area effectiveness.
• Ensure compliance with Good Clinical Practice (GCP) and country-specific regulations.

Job Requirements

• Bachelor’s degree in life sciences, medical, or scientific field required.
• Minimum of 2 years of relevant experience; advanced degree candidates require no prior experience.
• Proficiency in clinical trial systems such as CTSM, EDC, and TMF.
• Experience in site management and clinical trial operations preferred.
• Knowledge of Good Clinical Practice (GCP) and regulatory compliance essential.
• Nice-to-have: Experience with diabetes-related clinical research.
• Strong communication and organizational skills to manage cross-functional assignments.
• Ability to work on-site in a collaborative environment with general supervision.