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Clinical Research Associate
2 months ago
We are seeking a highly skilled Clinical Research Associate to join our team at Syneos Health. As a Clinical Research Associate, you will be responsible for managing clinical trials from site initiation to close-out, ensuring compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines.
Key Responsibilities- Conduct site qualification, site initiation, and site management visits to ensure regulatory compliance and data integrity.
- Verify informed consent processes and assess factors that may affect subject/patient safety and clinical data integrity.
- Conduct source document reviews, verify clinical data, and apply query resolution techniques to ensure data accuracy and completeness.
- Collaborate with site staff to resolve queries and ensure timely completion of study activities.
- Perform investigational product inventory, reconciliation, and reviews to ensure compliance with GCP and local regulations.
- Document activities and maintain accurate records, including confirmation letters, follow-up letters, trip reports, and communication logs.
- Support subject/patient recruitment, retention, and awareness strategies, and enter data into tracking systems as required.
- Understand project scope, budgets, and timelines, and manage site-level activities to ensure project objectives are met.
- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
- Knowledge of GCP/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.
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything we do.
We are committed to providing an environment and culture in which our people can thrive, develop, and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance.
