The Clinical Research Nurse manages complex study protocols, including patient screening, enrollment, and the administration of investigational interventions. They act as a liaison between the research team, clinical partners, and regulatory bodies to ensure adherence to Good Clinical Practice standards.
Requirements summary
Candidates must be a Registered Nurse (RN) with at least three years of relevant nursing experience and current BLS certification. Proficiency in electronic medical records and strong communication skills are required to manage study documentation and participant data.
professional certificateCommunicationNursingAttention to detailElectronic medical recordsRegulatory complianceData collectionPatient assessmentClinical researchPatient screeningInformed consentAdverse event reportingClinical trial managementMedical record abstractionGood clinical practiceProtocol management
Job description
Who is Saint Louis University?
Founded in 1818, Saint Louis University is one of the nation’s oldest and most prestigious Catholic universities.
SLU, which also has a campus in Madrid, Spain, is recognized for world-class academics, life-changing research, compassionate health care, and a strong commitment to faith and service.
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 a member of the team and resource for study protocol conduct acting as a liaison between the SLU SOM (School of Medicine), 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 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 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 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 MINIMUM QUALIFICATIONS RN with current registration to practice nursing in St.
Louis Three or more years of relevant nursing experience Current BLS Certification PREFERRED QUALIFICATIONS Clinical Research experience Function Clinical Research Scheduled Weekly Hours: 40 Saint Louis University is an equal opportunity/affirmative action employer.
All qualified candidates will receive consideration for the position applied for without regard to race, color, religion, sex, age, national origin, disability, marital status, sexual orientation, military/veteran status, gender identity, or other non-merit factors.
If accommodations are needed for completing the application and/or with the interviewing process, please contact Human Resources at 314-977-5847.
Saint Louis University is a premier employer in the St.
Louis region that attracts faculty and staff from around the world.
We recruit people of all faiths who share our mission to pursue truth for the greater glory of God and the service of others.
