Description
Syneos Health is seeking a CRA II to join their Clinical Solutions team. As a CRA II, you will be responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location.
Responsibilities:
- Conduct remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols
- Utilize data analytics and risk-based monitoring techniques to identify potential issues and trends
- Collaborate with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials
- Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits
- Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient
- Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site
- Apply query resolution techniques remotely and on-site, and provide guidance to site staff as necessary
- Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
Qualifications:
- 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