Clinical Research Nurse - Internal Medicine

Saint Louis University•SLU Saint Louis, MO

14h•Onsite

About The Position

The Clinical Research Nurse I is responsible for carrying out all delegated tasks related to complex protocols testing investigational drugs, devices, or research interventions. This role acts as a member of the team and a resource for study protocol conduct, serving as a liaison between the SLU SOM (School of Medicine), clinical partners (e.g., 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.

Requirements

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 and the electronic medical record)
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
RN with current registration to practice nursing in St. Louis
Three or more years of relevant nursing experience
Current BLS Certification

Nice To Haves

Clinical Research experience

Responsibilities

Reviews and abstracts medical record information and ensures proper adherence to randomization schema, study drug dosing and administration
Screens patients according to study criteria, randomize, enroll, and obtain consent
Schedules, performs, and/or supervises required study tests
Performs nursing assessments of study participants
Documents and records, in writing or electronically, all study events and protocol related procedures
Reviews clinical system billing charges for accuracy and appropriateness
Ensures that all required study event(s) and protocol related data are accurately and efficiently entered in the clinical trial management system
Applies knowledge of regulatory and institutional policies and processes appropriately in study documentation, protocol submissions, and standard operating procedures (SOPs)
Enters and collects study related data and develops per appropriate processes; ensures accuracy and completeness of data for all studies; recognizes and reports security of physical and electronic data vulnerabilities
Maintains participant-level documentation for all studies, including those that are complex in nature, require access to the EHR or require SLUCare/SSM charge routing; screens participants for complex studies (e.g., procedural, and interventional studies)
Conducts visits for complex studies (e.g., procedural, and interventional studies)
Identifies all adverse events (AEs) and determines whether or not they are reportable; collaborates with the PI to determine AE attributes, including relatedness to study; conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require clinical research orders in EHR
Performs other duties as assigned