Senior Clinical Research Specialist

Senior Clinical Research Specialist Overview

• The Senior Clinical Research Specialist oversees and designs clinical evaluation research studies, ensuring compliance with regulations and standards.
• Develops protocols, patient record forms, and conducts clinical studies for medical devices and products.
• Interprets clinical investigation results to support new device applications and commercial potential.
• Manages operational aspects of clinical trials, including site and vendor selection and clinical supply operations.
• Collaborates with project teams to ensure adherence to SOPs, GCP, and country-specific regulations.
• Provides mentorship and guidance to colleagues, fostering professional growth and development.
• Analyzes complex issues and recommends process improvements to enhance job area performance.
• Communicates effectively with senior internal and external stakeholders, influencing decision-making processes.
• Contributes to the achievement of work group objectives through relationship-building and consensus.

Senior Clinical Research Specialist Key Responsibilities & Duties

• Design and oversee clinical evaluation research studies, ensuring compliance with industry standards and regulations.
• Prepare and author clinical protocols, patient record forms, and study documentation.
• Conduct registered and non-registered clinical studies for medical devices and products.
• Interpret clinical investigation results to support product applications and commercial strategies.
• Manage site activation activities, site management tasks, and vendor selection processes.
• Ensure operational aspects of clinical trials align with SOPs, GCP, and regulatory requirements.
• Provide mentorship to colleagues and manage projects, delegating tasks and reviewing deliverables.
• Analyze complex issues and recommend improvements to enhance clinical research processes.
• Communicate with stakeholders to exchange information, influence decisions, and achieve objectives.

Senior Clinical Research Specialist Job Requirements

• Bachelor's degree in science or related field; advanced degree preferred.
• Minimum of 4 years of clinical research experience; 6 years preferred.
• Proficiency in site activation, site management, and vendor selection processes.
• Knowledge of SOPs, GCP, and country-specific regulations for clinical trials.
• Strong analytical skills to address complex issues and recommend process improvements.
• Effective communication skills to interact with senior stakeholders and influence decisions.
• Experience in managing projects and mentoring colleagues within the clinical research domain.
• Ability to work independently under limited supervision, delivering high-quality results.
• Familiarity with clinical supply operations and budget preparation for trials.