CRA II Italia home based
RemoteItaly
Job Summary
Conduct site qualification, initiation, interim monitoring, and close-out visits ensuring regulatory, ICH-GCP, and protocol compliance. Evaluate site performance, verify informed consent and data integrity, and assess factors affecting subject safety and clinical data quality. Perform source document reviews, verify CRF accuracy, and apply query resolution techniques to drive closure within timelines. Manage investigational product inventory, reconciliation, and security, ensuring proper labeling and administration. Reconcile Investigator Site Files with Trial Master Files and document activities via confirmation letters and trip reports. Support subject recruitment, retention, and awareness strategies while tracking observations and action items. Act as primary liaison with study site personnel, prepare for investigator meetings, and provide guidance on audit readiness standards.
Required 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
- Must demonstrate good computer skills and be able to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis
- Must be able to quickly adapt to changing priorities to achieve goals / targets
- Must comply with any Site requests for medical and other personal information to gain facility access as a condition of employment
Desired Qualifications
- Knowledge of local requirements for real world late phase study designs
- Experience with Chart abstraction activities and data collection
- Collaboration with Sponsor affiliates, medical science liaisons and local country staff
- Ability to train junior staff
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