Clinical Research Associate II
hace 4 días
Fortrea is seeking a highly motivated and detail-oriented Clinical Research Associate II to join our team. As a Clinical Research Associate II, you will be responsible for conducting site monitoring responsibilities for clinical trials, ensuring the protection of subjects, and safeguarding data integrity.
Key Responsibilities:- Conduct site monitoring responsibilities for clinical trials according to Fortrea's Standard Operating Procedures (SOPs), ICH guidelines, and GCP.
- Verify that informed consent procedures and protocol requirements are adhered to, alongside applicable regulatory requirements.
- Ensure data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines.
- Confirm Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
- Guarantee that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution.
- Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
- Thorough knowledge of monitoring procedures.
- Basic understanding of the clinical trial process.
- Fluent in local office language and in English, both written and verbal.
- A minimum of 2 years of Clinical Monitoring experience.
Must be able to sit at a computer for long periods of time. Must be able to use hands to finger, handle or touch objects, tools or controls, including a computer keyboard, for up to 8 hours per day. Standard office and/or home working environment. Clinical Research Unit and hospital environment (administrative only). Risk of eye strain. Will involve outside of normal office hours as required by the role. Travel Requirement is 60% of the time (traveling to study sites).
Fortrea is an Equal Opportunity Employer and does not discriminate based on race, religion, color, national origin, gender, family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.
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