Ich-gcp and good pharmacoepidemiology practice compliance
Source document review and crf verification
The role involves performing site qualification, initiation, interim monitoring, and close-out visits to ensure regulatory and protocol compliance
Job Summary
The role involves performing site qualification, initiation, interim monitoring, and close-out visits to ensure regulatory and protocol compliance.
Syneos Health offers a supportive culture focused on career development, technical training, and the 'Total Self' initiative where employees can authentically be themselves.
Candidates must demonstrate strong critical thinking skills and the ability to manage up to 75% travel while ensuring data integrity and patient safety.
Matching Summary
The role involves performing site qualification, initiation, interim monitoring, and close-out visits to ensure regulatory and protocol compliance.
Skills & Requirements
Must-have
Site qualification and initiation visits
ICH-GCP and Good Pharmacoepidemiology Practice compliance
Source document review and CRF verification
Informed consent process verification
Investigator Site File maintenance and reconciliation
Up to 75% travel requirement
Nice-to-have
Mentorship of junior CRA staff
Bid defense meeting participation
Real World Late Phase study experience
Chart abstraction activities
Collaboration with medical science liaisons
Key Requirements
Bachelor's degree or RN in related field
Knowledge of ICH Guidelines and GCP regulations
Excellent computer skills and technology adaptability