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About the Role

We're seeking an experienced Research Nurse Coordinator II to support Gastroenterology clinical trials. This role involves managing all aspects of studies from start-up through close-out, with a focus on regulatory compliance, subject coordination, and independent oversight during study start-up. The coordinator will assist investigators as coordinator of a complex clinical research study; may be responsible for multiple research studies simultaneously, acting as a liaison with the school, sponsoring agency, community and the study participants; manages and records all phases of study protocol as required by sponsoring agency to ensure compliance.

Responsibilities

Works under the Principal Investigator’s (PI) guidance to meet the research objective of the project.
Facilitates and implements study start-up activities including trial feasibility assessment, study logistics, IRB submissions, and other applicable regulatory requirements, budgetary and contract review and approval.
Provides direct patient care, including assessment, planning, implementation and evaluation of patients; documents, collects data and assists physicians.
Works with research team to identify, screen and enroll study subjects.
Ensures protocol requirements are met including direct contact with research participants, collection of basic health information, coordination of study related procedures, handling, processing and shipping of research specimens, source documentation and data entry.
May train and supervise staff assigned to work on the research project(s).
Coordinates handling of specimens, administration of clinical trials, collection of source information and case reporting.
Prepares/submits reportable event reports to sponsor(s), IRBs and regulatory agencies in accordance with the study protocol and established policies, procedures, and regulations.
Collaborates with sponsor’s research associates during monitoring activities by providing study documentation, data clarifications and reports as necessary.
Authorizes payments to ancillary organizations for services rendered and reconciles payments from organizations serviced.
Demonstrates experience in clinical trials management including strong organizational skills, independence and resourcefulness and an increased responsibility for the day-to-day conduction and oversight of multiple clinical trials.
Provides oversight of administration of study medications and/or study interventions.
Administers investigational products in approved settings.
Educates staff nurses caring for research patients by providing necessary information about the research study including intervention and potential adverse events and required study procedures.
Performs other duties incidental to the work described above.

Requirements

Associate Degree In Nursing Or Diploma In Registered Nursing
Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirements).
A Class E (MO) or Class D (IL) license and a good driving record are required for this position.

Skills

Active Listening
Clinical Research Coordination
Clinical Research Management
Clinical Research Methods
Clinical Research Operations
Clinical Techniques
Database Management
Detail-Oriented
Effective Written Communication
Electronic Health Records (EHR)
Nursing Fundamentals
Oral Communications
Patient Recruitment
Reporting Tools
Spreadsheet Software
Statistical Analysis Software (SAS)
Team Collaboration

Location

SAINT LOUIS, MO 63110

Work Type

40 hours
Patient care setting
Direct patient care setting

Experience Level

2 Years Research
2 Years Nursing
3+ years of clinical nursing experience, ideally in Gastroenterology or adjacent diseases/specialties.
Prior working knowledge of techniques and methodologies used in developing, coordinating and managing clinical research projects with a prior experience as a research nurse coordinator in industry or academic environment for at least 2 years.

Education Level

Associate Degree In Nursing Or Diploma In Registered Nursing
Bachelor of Science in Nursing

Salary/Compensations

$64,500.00 - $109,900.00 / Annually

Benefits

Up to 22 days of vacation, 10 recognized holidays, and sick time.
Competitive health insurance packages with priority appointments and lower copays/coinsurance.
Free Metro transit U-Pass for eligible employees.
WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%.
Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!
4 weeks of caregiver leave to bond with your new child.
Family care resources are also available for your continued childcare needs.
Adult care resources are available.
WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us.

About the Company

Washington University in St. Louis

Equal Opportunity

Washington University in St. Louis is committed to the principles and practices of equal employment opportunity. It is the University’s policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, citizenship (where prohibited by federal law), age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.