Role Responsibilities:
Coordinate clinical research studies and maintain a safe study environment according to health and safety policies under the direction and delegation of the Principal Investigator
Safeguard the well-being of subjects, act as a volunteer advocate, and address subject’s concerns while ensuring the highest quality-of-care practices
Maintain up-to-date study protocols, case report forms (CRFs), Electronic Data Capture (EDC) systems, and other study documents
Plan and coordinate logistical activity for study procedures according to the study protocol
Perform clinical set-up and preparation for the study including labeling specimen collection tubes and containers, inventory of required supplies, and setting up or troubleshooting equipment and/or study issues
Assist with data entry, data quality checking, and query resolution to ensure adherence to study protocol and quality control for content accuracy and completeness
Assist in study enrollment by recruiting, screening, and orienting volunteers according to the study protocol
Correct custody of study drug according to site standard operating procedures
Perform a variety of complex clinical procedures on subjects including but not limited to vital signs, phlebotomy, etc.
Collect, record, and report clinical data and findings appropriately in CRFs while collaborating with study investigator about study-related adverse events and serious adverse events according to the study protocol.
Qualifications
Bachelor's Degree
Actual onsite experience (2-3 years)
Working knowledge of clinical trials
Working knowledge of the principles of Good Clinical Practices (GCP)
In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
Skill in carrying out required clinical procedures such as intravenous catheter insertion and spirometry testing
Good skill in using MS Windows and Office applications such as Access, Outlook and Word
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com