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 each subject/patient
- Assess factors that might affect subject/patient's safety and clinical data integrity
- Conduct Source Document Review and verify required clinical data entered in case report form (CRF)
- 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 (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, and other required project documents
- Support subject/patient recruitment, retention, and awareness strategies
- Enter data into tracking systems as required
- 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 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