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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 ensuring the successful execution of clinical trials by conducting site qualification, site initiation, and site management visits. You will work closely with investigators, site staff, and other stakeholders to ensure compliance with regulatory requirements and study protocols.
Key Responsibilities- Conduct site qualification, site initiation, and site management visits to ensure compliance with regulatory requirements and study protocols.
- Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
- Assess factors that might affect subject/patient safety and clinical data integrity at an investigator/physician site.
- Conduct source document review of site source documents and medical records to verify required clinical data entered in the case report form (CRF) is accurate and complete.
- Apply query resolution techniques remotely and on-site, and provide guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
- Utilize available hardware and software to support the effective conduct of the clinical study data review and capture.
- Verify site compliance with electronic data capture requirements.
- May perform investigational product (IP) inventory, reconciliation, and reviews storage and security.
- 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.
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 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.
