"Clinical Research Assistant A"

Job Description Summary

Clinical Research Assistant (CRA) under direct supervision will assist research staff with a variety of tasks to support ongoing clinical research studies in the Chirinos lab.

• Supports and interacts with clinical research coordinators
• Attends study related meetings
• Assists in obtaining appropriate signatures for regulatory forms
• Assists in the preparation of documents needed for initiation, monitoring and close-out visits with sponsors and/or clinical research organization; includes clerical support, copying, gathering information
• Maintains documentation, case report forms and study binders required by sponsor or Clinical Research Organization (CRO) as directed by Supervisor, Clinical Research Nurse (CRN), or Clinical Research Coordinator (CRC)
• Obtains records required to complete case report forms
• Assists in preparation and submission of regulatory documents (including continuing review, amendments, and adverse event reporting) to the University of Pennsylvania Institutional Review Board (IRB); includes making copies per IRB requirements and delivery of documents to the IRB
• Assists in email and other clerical duties as request by CRC or Supervisor
• Assists in screening for potential patients for research studies and collaborates and confers with PI or clinical research coordinator for final approval of the potential patient as a candidate for the study
• Schedules clinical research study patient appointments
• Prepare study related research lab kits
• Coordinate research specimen collection and delivery
• Processes and ships blood, urine, and serum specimens for clinical trails
• Assists in resolving regulatory related queries with, IRB, CRO and sponsors
• Performs related duties as assigned

Job Responsibilities

• Collecting patient information, processing patient specimens, distributing materials to various campus locations
• Contacting patients for protocol follow-up, developing research tools, preparing for internal and external audits
• Data management and entry, data reporting to various research organizations
• Maintaining research files/charts with up-to-date information, etc
• Other duties and responsibilities as assigned

Qualifications

High School Grad/GE Degree and 1 to 2 years of experience or equivalent combination of education and experience is required.