Clinical Operations Specialist

2 weeks ago

Pune, Maharashtra, India Syneos Health Full time
Job Description

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

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