Description
Syneos Health is seeking a Clinical Research Associate (CRA) to join their team.
The CRA will perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
Responsibilities:
- Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits
- Evaluate overall performance of site and site staff and provide recommendations regarding site-specific actions
- Verify process of obtaining informed consent and document confidentiality of subjects/patients
- Assess factors affecting subject/patient's safety and clinical data integrity
- Conduct Source Document Review and verify clinical data entered in case report forms
- Apply query resolution techniques and provide guidance to site staff
- Utilize available hardware and software to support clinical project data review and capture
- Perform investigational product inventory, reconciliation, and reviews storage and security
- Routinely review Investigator Site File and reconcile contents with Trial Master File
- Document activities via confirmation letters, follow-up letters, trip reports, and communication logs
- Support subject/patient recruitment, retention, and awareness strategies
- Enter data into tracking systems to track observations and action items
- Understand project scope, budgets, and timelines, and manage site-level activities
- Act as primary liaison with project site personnel and ensure training and compliance
- Prepare for and attend Investigator Meetings and sponsor face-to-face meetings
- Provide guidance on audit readiness standards and support preparation for audits
For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I. Additional responsibilities include:
- Site support throughout the study lifecycle
- Knowledge of local requirements for real-world late-phase study designs
- Chart Abstraction activities and data collection
- Collaboration with Sponsor affiliates, medical science liaisons, and local country staff
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 other applicable regulatory requirements
- Good computer skills and ability to adapt to new technologies
- Excellent communication, presentation, and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis