Clinical Research Associate II (CRA II) Role Summary
Perform site qualification, site initiation, and close-out visits ensuring regulatory compliance. Evaluate site performance, provide recommendations, and maintain a working knowledge of ICH/GCP guidelines.
Job Description:
Key Responsibilities:
* Conduct site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
* Verify informed consent processes, assess subject/patient safety, and integrity of clinical data at investigator sites.
* Apply query resolution techniques, drive query resolution to closure, and verify required clinical data entered in case report forms.
* May perform investigational product inventory, reconciliation, storage, and security reviews.
* Review Investigator Site Files for accuracy, timeliness, and completeness, and reconcile contents with Trial Master Files.
Additional Responsibilities for Real World Late Phase Studies:
* Site support throughout the study lifecycle from site identification through close-out.
* Knowledge of local requirements for real-world late-phase study designs.
* Chart abstraction activities and data collection.
* Collaboration with Sponsor affiliates, medical science liaisons, and local country staff.
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.
* Excellent communication, presentation, and interpersonal skills.
* Ability to manage required travel of up to 75% on a regular basis.