Clinical Research Nurse

JOB SUMMARY

The Clinical Research Nurse I is responsible to carry out all delegated tasks related to complex protocols testing investigational drugs, devices, or research interventions. The Clinical Research Nurse I is a member of the team and resource for study protocol conduct acting as a liaison between the SLU SOM, clinical partners (ex. SSM Health), the Principal Investigator, Institutional Review Board (IRB), and sponsors to ensure good clinical practice standards (GCP) throughout the life cycle of the study.

PRIMARY JOB RESPONSIBILITIES

• Screen patients according to study criteria and confirm study eligibility
• Obtain informed consent from participants or legally authorized representatives
• Enroll participants in observational and interventional studies, e.g. drug or device trials
• Schedule, perform, and/or supervise required study visits and tests
• Perform nursing history and assessments of study participants
• Review and abstract medical record information and ensure proper adherence to clinical trial randomization schema, study drug dosing and administration
• Review clinical system billing charges for accuracy and appropriateness
• Ensure that all required study events and protocol related data are accurately and efficiently entered in the clinical trial management system
• Apply knowledge of good clinical practice, federal, state, and institutional policies and processes
• Prepare regulatory documents, e.g. institutional review board application
• Collect and maintain essential documents for research compliance
• Collaborate with other research and healthcare professionals in the conduct of interdisciplinary studies
• Identify adverse events (AEs) and determine whether or not they are reportable; collaborate with the PI to determine AE attributes, including relatedness to study
• Performs other duties as assigned

KNOWLEDGE, SKILLS & ABILITIES

• Knowledgeable in regulatory and institutional policies and processes
• Proficiency in electronic medical records and relevant computer software
• Strong verbal and written communication skills and attention to detail
• Ability to use computing software and web-based applications, e.g., Microsoft Office products, electronic medical records
• Ability to work in a team environment to facilitate the integrity of the study and its timely completion
• Ability to travel to off-site locations

MINIMUM QUALIFICATIONS

• RN with current registration to practice nursing in Missouri
• Three or more years of relevant nursing experience
• Current BLS Certification

PREFERRED QUALIFICATIONS

• Clinical Research experience