Clinical Research Associate
6 days ago
Job Title: Senior Clinical Research Associate I
Syneos Health is a leading biopharmaceutical solutions organization dedicated to accelerating customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities.
Job Summary
We are seeking a highly skilled Senior Clinical Research Associate I to join our team. As a Senior Clinical Research Associate I, you will be responsible for performing site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory compliance and protocol adherence.
Responsibilities
- Perform site qualification, site initiation, and close-out visits to ensure regulatory compliance and protocol adherence.
- Verify the process of obtaining informed consent 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.
- Utilize available hardware and software to support effective clinical study data review and capture.
- Perform investigational product inventory, reconciliation, and reviews storage and security.
- Document activities via confirmation letters, follow-up letters, trip reports, and communication logs.
- Support subject/patient recruitment, retention, and awareness strategies.
Requirements
- Bachelor's degree or RN in a related field or equivalent combination of education, training, 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 Syneos Health
Syneos Health is a leading biopharmaceutical solutions organization with over 29,000 employees across 110 countries. We have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
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