Description
Syneos Health is seeking a Sponsor Dedicated CRA II/Sr CRA I/II to work from home in Italy.
The successful candidate will perform site qualification, site initiation, interim monitoring, site management, 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
- Understanding project scope, budgets, and timelines to ensure objectives are met
- Providing guidance on audit readiness and supporting preparation for audits
- May provide training or mentorship to junior CRAs
Requirements:
- At least 2.5 years of experience as a Certified CRA
- Oncology monitoring experience and phase I experience preferred
- Experience with Risk-Based Monitoring is a plus
- Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
- Good computer skills and ability to adapt to new technologies
- Excellent communication, presentation, and interpersonal skills
- Ability to manage up to 75% travel
The potential annual gross salary range for this role is 45,000.00 EUR - 69,000.00 EUR, excluding any additional benefits and allowances.