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Senior Clinical Research Associate I
2 months ago
We are seeking a highly skilled and experienced Senior Clinical Research Associate I to join our team at Syneos Health. As a key member of our clinical operations team, you will be responsible for ensuring the successful execution of clinical trials, from site qualification to close-out.
Key Responsibilities- Site Management: Perform site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
- Regulatory Compliance: Verify the process of obtaining informed consent, assess factors that might affect subject/patient safety and clinical data integrity, and maintain a working knowledge of ICH/GCP Guidelines and other applicable regulations.
- Site Support: Provide guidance to site staff, conduct source document reviews, and verify required clinical data entered in the case report form (CRF) is accurate and complete.
- Investigational Product Management: Perform IP inventory, reconciliation, and reviews storage and security, and verify issues or risks associated with blinded or randomized information related to IP.
- Documentation and Communication: Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents.
- Collaboration and Leadership: Collaborate with project site personnel, participate in global clinical monitoring/project staff meetings, and provide guidance at the site and project level towards audit readiness standards.
- Education: Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
- Knowledge and Skills: Good understanding of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements, excellent communication, presentation, and interpersonal skills, and 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 that we do.
We are passionate about developing our people, through career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
