
Study Site Operations Specialist Senior
3 days ago
The Clinical Research Associate II/Sr CRA plays a critical role in ensuring the successful execution of clinical trials by conducting site qualification, initiation, interim monitoring, and close-out visits. This role requires a strong understanding of Good Clinical Practice (GCP) guidelines and the ability to communicate effectively with study site personnel. Key responsibilities include verifying informed consent processes, assessing factors affecting subject safety, and maintaining a working knowledge of ICH/GCP guidelines. Additionally, this role involves providing guidance at the site and project level towards audit readiness standards and supporting preparation for audits and follow-up actions. If you have a passion for clinical research and a commitment to excellence, we encourage you to apply for this exciting opportunity
Key Responsibilities
* Conducts site qualification, initiation, interim monitoring, and close-out visits to ensure regulatory compliance
* Verifies informed consent processes and assesses factors affecting subject safety
* Maintains a working knowledge of ICH/GCP guidelines and relevant regulations
* Communicates effectively with study site personnel and manages site-level activities
Requirements
* Bachelor's degree or RN in a related field or equivalent combination of education and experience
* Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
* Excellent communication, presentation, and interpersonal skills
* Ability to manage required travel of up to 75% on a regular basis
About the Company
Syneos Health, Inc. is a global biopharmaceutical company committed to delivering innovative therapies to patients in need. Our team of experts provides integrated clinical, medical affairs, and commercial solutions to accelerate customer success. We are dedicated to building a diverse, inclusive, and authentic workplace where employees can grow and thrive.
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