Description
Syneos Health is seeking a Sponsor Dedicated CRA I/II to join their team in the Sofia area. As a CRA, you 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, providing recommendations regarding site-specific actions
- Verify process of obtaining informed consent, protect confidentiality of subjects/patients
- Assess factors affecting subject/patient's safety and clinical data integrity
- Conduct Source Document Review, verify clinical data entry, apply query resolution techniques
- Manage investigational product inventory, reconciliation, and storage/security
- Review Investigator Site File, reconcile contents with Trial Master File
- Document activities via confirmation letters, follow-up letters, trip reports, and other required project documents
- Support subject/patient recruitment, retention, and awareness strategies
- Enter data into tracking systems to track observations, ongoing status, and assigned action items
- Adapt to changing priorities to achieve goals/targets
- Act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate
- Prepare for and attend Investigator Meetings and/or 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
- Previous exposure (up to 2 yrs) to monitoring activities
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Good computer skills, ability to embrace new technologies
- Excellent communication, presentation, and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis