Precision for Medicine - Clinical Research Associate
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Requirements
• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline. • Minimum of 2 years of on-site monitoring experience; 1 year oncology experience； • Global Clinical Trial experience • High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint). • Customer service demeanour; demonstrate flexibility and teamwork. • Ability to focus on detail for extended periods of time, high attention to accuracy. • Fluency in English communication, verbally and in writing. • Working knowledge of the drug development process. • Travelling required (60-70%) • Preferred: • Solid experience in clinical research or related experience. • Excellent organizational skills. • Ability to work efficiently in a remote work environment. • Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Responsibilities
• Oversees all aspects of study site management to ensure patient safety. • Ensures quality data generation by managed sites with low query levels in QA reports. • Provides guidance towards audit readiness standards and supports preparation for audits, including follow-up actions as required. • Updates, tracks, maintains trial specific tools/systems, status reports. • Manages site start up procedures if necessary: feasibility studies, recruitment of investigators, EC/IRB submissions, regulatory document collection and review, Patient Informed Consents adaptation, notifications to IRB, EC, and authorities as appropriate; translation of study related documentation; organization of meetings. • Assists in the negotiation of study budgets and execution of contracts under Site Contract Management department/designee direction if required. • Verifies informed consent process adequacy for each subject or patient. • Assesses factors affecting safety, protocol deviation violations, pharmacovigilance issues at investigator sites. • Independently conducts all forms of site visits (pre-study/qualification, initiation, routine monitoring, close-out) in accordance with the protocol and local laws; ICH-GCP standards as applicable to Precision for Medicine's operations.
Benefits
• None stated.
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