Description
Syneos Health is seeking a Clinical Research Associate (CRA) to join their team. The CRA will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits. The successful candidate will have a strong understanding of Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements.
Responsibilities:
- Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits
- Evaluate overall performance of site and site staff, providing recommendations regarding site-specific actions
- Verify process of obtaining informed consent, demonstrating diligence in protecting subject/patient confidentiality
- Assess factors affecting subject/patient safety and clinical data integrity
- Conduct Source Document Review, verify clinical data entered in case report forms, and apply query resolution techniques
- Manage investigational product inventory, reconciliation, and storage/security
- Review Investigator Site File (ISF) for accuracy, timeliness, and completeness
- Document activities via confirmation letters, follow-up letters, trip reports, and communication logs
- Support subject/patient recruitment, retention, and awareness strategies
- Prepare for and attend Investigator Meetings and sponsor face-to-face meetings
- Provide guidance at site and project level towards audit readiness standards
Qualifications:
- 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 regulatory requirements
- Excellent communication, presentation, and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis