Description
Syneos Health is seeking a Clinical Research Associate II to join their team.
The Clinical Research Associate II 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:
- Performing site qualification, site initiation, and close-out visits
- Evaluating site performance and providing recommendations
- Verifying informed consent and protecting subject confidentiality
- Assessing site processes and conducting source document reviews
- Applying query resolution techniques and providing guidance to site staff
- Managing investigational product inventory and reconciliation
- Reviewing investigator site files and trial master files
- Documenting activities and supporting subject recruitment and retention
- 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
- Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
- Excellent communication and interpersonal skills
- Ability to manage required travel of up to 75%
Syneos Health offers a range of benefits, including career development and progression, supportive line management, technical and therapeutic area training, and total rewards programs.