Clinical Operations Specialist

Job Responsibilities

• Safeguarding the wellbeing of research subjects in a medical capacity, ensuring that all procedures are conducted with the highest standards of care and safety
• Reviewing study protocols and executing procedures in alignment with protocols and regulatory, health, and safety standards, ensuring compliance with all relevant guidelines and regulations
• Recruiting and coordinating communication with clinical trial volunteers and patients, maintaining clear and effective communication throughout the study
• Following applicable regulations globally and by region, ensuring that all activities are conducted in accordance with local and international standards
• Collaborating with cross-functional teams to develop study materials, including informed consent forms, study manuals, and other essential documents
• Monitoring trial progress and addressing any issues that arise during the study, ensuring that all problems are promptly identified and resolved
• Providing organizational related support or service, typically under supervision, assisting with administrative tasks and other support activities as needed
• Performing routine tasks with some deviation from standard practice, adapting to changing circumstances and requirements as necessary
• Utilizing broad knowledge of operational systems and practices gained through extensive experience and/or education, applying this knowledge to improve study processes and outcomes
• Qualifications
• High school diploma or equivalent required
• Associate's degree or higher in a related field preferred
• Minimum of 2 years of experience in clinical operations or a related field
• Strong understanding of clinical research protocols and regulatory requirements
• Certifications
• Certified Clinical Research Coordinator (CCRC) or equivalent certification preferred
• Basic Life Support (BLS) certification required
• Necessary Skills
• Excellent communication and interpersonal skills
• Strong organizational and time management abilities
• Attention to detail and accuracy in documentation
• Ability to work effectively in a team environment
• Proficiency in Microsoft Office Suite and clinical trial management software
• Get to know Syneos Health
• Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA