Description
Syneos Health is seeking a CRA II (Multi-sponsor) with ophthalmology experience to work from home in Brazil.
The successful candidate will perform 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 site performance and providing recommendations for site-specific actions
- Verifying informed consent and protecting subject/patient confidentiality
- Assessing site processes and conducting source document reviews
- Applying query resolution techniques and providing guidance to site staff
- Managing investigational product inventory and verifying dispensing and administration
- Reviewing investigator site files and reconciling contents with trial master files
- Documenting activities and supporting subject/patient recruitment and retention
- Preparing for and attending investigator meetings and sponsor face-to-face meetings
- Providing guidance on audit readiness and supporting preparation for audits
The ideal candidate will have:
- A bachelor's degree or RN in a related field or equivalent experience
- Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
- Excellent communication, presentation, and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis