Clinical Research Associate II

Job Title

Job Overview:

Requirement/Must Have:

• 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.