Research Nurse Coordinator II - Gastroenterology (IBD)

Position Summary

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.

Primary Duties & 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 (but not limited to): trial feasibility assessment; study logistics; IRB (both local and central) 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 but not limited to: 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, as appropriate. 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.

Working Conditions

• Normal office environment
• Exposure to blood-borne pathogens
• Requires protective devices
• Patient care setting
• Direct patient care setting

Physical Effort

• Typically sitting at desk or table
• Typically bending, crouching, stooping
• Occasional lifting (25 lbs or less)

Required Qualifications

• Associate Degree in Nursing or Diploma in Registered Nursing
• Basic Life Support certification (Online BLS certifications without a skills assessment component are not sufficient) – American Heart Association or American Red Cross
• Registered Nurse – Illinois Department of Financial and Professional Regulation or Missouri Division of Professional Registration
• Research (2 years)
• Nursing (2 years)
• Class E (MO) or Class D (IL) license and a good driving record

Preferred Qualifications

• Clinical Research Certification
• Bachelor of Science in Nursing
• Proficient in phlebotomy
• Familiarity with EHR systems
• Working knowledge of database management, spreadsheet, and statistical analysis software
• Experience with phase I - IV industry-sponsored trials
• 3+ years of clinical nursing experience, ideally in Gastroenterology or adjacent diseases/specialties
• Experience in care coordination, ambulatory care, case management, or a related setting
• GCP and IATA certified
• 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

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

Benefits

• Personal: 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.
• Retirement Savings Plan: defined contribution (403(b)) with employee contributions and university contributions starting at 7%.
• Wellness: wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more.
• Family: 4 weeks of caregiver leave to bond with your new child; family care resources for continued childcare needs; adult care resources.
• Tuition: 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.

Pay

Salary Range: $64,500.00 - $109,900.00 / Annually