Description
Syneos Health is seeking a CRA II (Multi-sponsor) to work from home in Mexico.
As a CRA II, 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 each subject/patient
- Assess factors affecting subject/patient's safety and clinical data integrity
- Conduct Source Document Review, verify clinical data entered in case report form (CRF) is accurate and complete
- Apply query resolution techniques, provide guidance to site staff as necessary
- Perform investigational product (IP) inventory, reconciliation, and reviews storage and security
- Routinely review Investigator Site File (ISF) for accuracy, timeliness, and completeness
- Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
- Support subject/patient recruitment, retention, and awareness strategies
- 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
- 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