Clinical Research Associate II
Cynet Systems
- Durham, North Carolina, United States
- Durham, North Carolina, United States
Über
Minimum 2+ years monitoring experience. One year or more obesity monitoring experience. Strong endocrinology monitoring experience (2+ years monitoring) is considered.
Responsibilities:
Work directly at patient/subject interface at investigator sites to deliver high-quality patient data in accordance with local regulations, agreed scope of work, and as required by protocol. Facilitate timely start-up of all studies at the site by ensuring timely completion/submission of regulatory documents and ethics approvals and IP release documents. Attend and participate in investigator meetings, monitoring visits, audits, seminars and other regional or national meetings. Assist with screening and enrollment of subjects into assigned studies. Support subjects on trials to encourage maximum retention and future recruitment. Assist with the establishment of a recruitment and contingency plan for each study. Perform functions necessary for successful completion of all protocol required visits/procedures such as vital signs, phlebotomy, diagnostic tests, dispensing of investigational product, scheduling, drug accountability/reconciliation and organizational tasks, where appropriate and as delegated by the investigator, in accordance with local country requirements. Accurately complete source documents and case report forms in both paper and electronic format. Assist investigator with recording and reporting of adverse events as per local regulatory authority guidelines. Ensure documentation of data protection agreement is on file for assigned site where necessary and in accordance with local country requirements.
Skills:
Good knowledge of medical terminology. Above-average interpersonal and organizational skills. Proficient use of Microsoft Office. Ability to work independently, prioritize actively, seek input, problem solve and work in a team environment. Ability to maintain confidentiality. Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Qualification And Education:
Registered nurse, medical physician or appropriate educational qualification.
Sprachkenntnisse
- English
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