Description
Syneos Health is seeking a CRA II or SrCRA to work in a home-based setting.
As a CRA II or SrCRA, you will be responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. You will utilize data analytics and risk-based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices.
Key responsibilities include:
- Performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits (performed on-site or remotely) to ensure regulatory, ICH-GCP, and protocol compliance
- Verifying the process of obtaining informed consent has been adequately performed and documented for each subject/patient
- Assessing factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site
- Conducting Source Document Review of appropriate site source documents and medical records
- Applying query resolution techniques remotely and on-site, and providing guidance to site staff as necessary
- Managing site-level activities and communication to ensure project objectives, deliverables, and timelines are met
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
Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.