[Position] CRA (Clinical Research Associate)
[Responsibilities]
• Participate in the planning of a study or multiple studies with the CRM. • Perform operation and administrative duties assigned by the CRM • Review data in the electronic data capture system; enter and reconcile queries as necessary.
May also be involved in query resolution • Monitor site preparation, including sending regulatory document packages to sites • Assist with the CRO selection process and ensure contractual obligations are met • Assist CRM with Vendor identification and selection and payments vis a vis contractual agreements.
Contribute to development of a payment schedule section for Vendors and process/obtain approval from
management • Involve in the planning and coordinating investigation meetings. Prepare and present protocol and general
study-related presentation to field monitors, investigations and adequately informed of protocol requirements,
standard operating procedures and monitoring procedures • Participate in the development of site reference materials
[Requirements]
• Bachelor's degree in a health or science related field. A RN or BSN is strongly preferred. • 5+ years of experience in Clinical Research is required. Global experience is a plus. • Must have experience with site qualification, initiation, regular monitoring and site close-out visits. • Demonstrates an understanding of regulatory requirements including a working knowledge of governmental
guidelines. • Must have knowledge of EDC system. • Must have good written and verbal skills to communicate effectively with investigators and departmental personnel
about protocol related topics.
Must be able to present reports and updates at Project and Staff meetings (powerpoint) • Ability to make independent decisions for CRM back up. • Must possess strong technical skills and include a working knowledge of Microsoft Office
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