Description
Syneos Health is seeking a CRA II - Sr.CRA I for FSP BU, South Korea.
The Clinical Research Associate (CRA) will play a crucial role in ensuring the quality and integrity of clinical trials. The successful candidate will be responsible for performing site qualification, site initiation, interim monitoring, site management, and close-out visits.
Key responsibilities include:
- Conducting site qualification, site initiation, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance
- Evaluating the overall performance of site staff and providing recommendations for site-specific actions
- Verifying the process of obtaining informed consent from subjects/patients
- Assessing factors that might affect subject/patient safety and clinical data integrity
- Conducting source document reviews and verifying required 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, deliverables, and timelines 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
- May act as primary liaison with study site personnel or in collaboration with Central Monitoring Associate
- May provide direct supervision, training, and/or mentorship to more junior level CRAs
The ideal candidate will have:
- A 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 dynamic and supportive work environment, opportunities for career development and progression, and a range of benefits to support employees.