Description
Syneos Health is seeking a CRA II or SrCRA, Multi Sponsor, based in Serbia.
As a CRA II or SrCRA, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
Key responsibilities include:
- Evaluating the overall performance of site and site staff, and providing recommendations regarding site-specific actions
- 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
- Preparing for and attending Investigator Meetings and/or sponsor face-to-face meetings
- Providing guidance at the site and project level towards audit readiness standards and supporting preparation for audit and required follow-up actions
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.