Senior Clinical Research Specialist

Overview

• Contribute to clinical research initiatives within a leading healthcare organization, focusing on medical device studies and regulatory compliance.
• Collaborate remotely with cross-functional teams to ensure successful site activation and management activities.
• Design, plan, and oversee clinical evaluation research studies, ensuring adherence to SOPs and GCP guidelines.
• Prepare and author protocols, patient record forms, and clinical trial budgets.
• Interpret results of clinical investigations for new medical device applications.
• Provide mentorship to colleagues and manage projects independently under limited supervision.
• Utilize specialized knowledge and skills acquired through advanced education and industry experience.
• Engage with senior internal and external stakeholders to exchange information and influence decision-making.

Key Responsibilities & Duties

• Oversee the design and implementation of clinical evaluation research studies for medical devices.
• Prepare protocols, patient record forms, and manage clinical trial budgets.
• Conduct registered and nonregistered clinical studies, ensuring compliance with regulatory standards.
• Resolve operational aspects of clinical trials in collaboration with project teams.
• Select and manage clinical supply operations, sites, and vendors.
• Provide guidance and coaching to team members, fostering professional development.
• Analyze complex problems and recommend process improvements to enhance job area performance.
• Communicate with stakeholders to exchange ideas and influence decision-making effectively.

Job Requirements

• Bachelor of Science (BS) degree required; advanced degree preferred.
• Minimum of 3 years of clinical research experience; 4 years preferred.
• Proven expertise in site activation and management activities.
• Experience with medical device studies highly desirable.
• Knowledge of SOPs, GCP guidelines, and regulatory compliance standards.
• Strong project management skills with the ability to work independently.
• Effective communication and collaboration skills with internal and external stakeholders.
• Ability to mentor colleagues and manage projects/processes effectively.