Clinical Research Specialist

Overview

• Contribute to clinical research projects, ensuring compliance with regulations and Good Clinical Practice (GCP).
• Collaborate with teams to design, plan, and execute clinical evaluation studies.
• Prepare and author protocols, patient record forms, and study documentation.
• Oversee operational aspects of clinical trials, including site and vendor selection.
• Interpret clinical investigation results for new drug, device, or consumer applications.
• Ensure adherence to standard operating procedures and regulatory requirements.
• Contribute to project milestones and cross-functional assignments.
• Provide guidance to entry-level professionals and support staff.

Key Responsibilities & Duties

• Design and develop clinical evaluation research studies aligned with project objectives.
• Prepare protocols, patient record forms, and other study-related documentation.
• Conduct and oversee registered and nonregistered clinical studies.
• Interpret clinical investigation results for product applications.
• Manage operational aspects of clinical trials, ensuring compliance with GCP.
• Select and manage clinical trial sites and vendors.
• Collaborate with project teams to achieve desired outcomes.
• Provide mentorship and guidance to junior team members.

Job Requirements

• Bachelor’s degree in engineering, life sciences, or a related medical/scientific field.
• Minimum of 2 years of experience in clinical research or related roles.
• Proficiency in CTMS, EDC, and TMF systems.
• Strong knowledge of Good Clinical Practice (GCP) guidelines.
• Experience in site management, either at site or sponsor level.
• Ability to work full-time on-site as per project requirements.
• Excellent communication and collaboration skills.
• Capability to manage moderately complex projects independently.