Clinical Research Associate

Iqvia • Field based, CA

18h

About The Position

The Clinical Research Associate works as an integral member of site staff, maintaining day-to-day relationships with partner sites. The role involves planning, coordinating and, as appropriate, executing clinical studies in accordance with the protocol, contracted scope of work, SOPs, and relevant local guidelines and regulations. This is a 12-month contract and is field-based.

Requirements

• Good knowledge of medical terminology.
• Above-average interpersonal and organizational skills.
• Proficiency with Microsoft Office.
• Fluency in the local language, spoken and written.
• Fluency in written English.
• Ability to work independently, prioritize actively, seek input, solve problems, and work in a team environment.
• Ability to maintain confidentiality.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Registered nurse, medical physician, or appropriate educational qualification.

Responsibilities

• Work directly with patients or subjects at investigator sites to deliver high-quality patient data in accordance with local regulations, the agreed scope of work, and protocol requirements.
• Facilitate timely study start-up by ensuring timely completion and submission of regulatory documents, ethics approvals, and investigational product 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 trial subjects to encourage retention and future recruitment.
• Assist in establishing a recruitment and contingency plan for each study.
• Perform functions needed to complete protocol-required visits and procedures, including vital signs, phlebotomy, diagnostic tests, investigational product dispensing, scheduling, drug accountability and reconciliation, and organizational tasks, where appropriate and delegated by the investigator, in accordance with local country requirements.
• Accurately complete source documents and case report forms in paper and electronic formats.
• Assist the investigator with recording and reporting adverse events in accordance with local regulatory authority guidelines.
• Ensure documentation of data protection agreements is on file for assigned sites where necessary and in accordance with local country requirements.

What This Job Offers

• Education Level: No Education Listed