Description
Syneos Health is seeking a Clinical Research Associate (CRA) to join their team.
As a CRA, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits.
Key responsibilities include:
- Evaluating overall performance of site and site staff
- Providing recommendations regarding site-specific actions
- Communicating and escalating serious issues to the project team
- Developing action plans
- Verifying informed consent has been adequately performed and documented
- Assessing factors that might affect subject/patient's safety and clinical data integrity
- Conducting source document reviews and verifying clinical data entered in case report forms
- Applying query resolution techniques and providing guidance to site staff
- Managing site-level activities and communication to ensure project objectives are met
- Preparing for and attending investigator meetings and sponsor face-to-face meetings
- Providing guidance at the site and project level towards audit readiness standards
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