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.

SAINT LOUIS, MO 63110

40

• 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.

Job Location/Working Conditions

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

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

• Office equipment
• Clinical/diagnostic equipment

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. It is not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.

Associate Degree In Nursing Or Diploma In Registered Nursing

Basic Life Support
- American Heart Association, Basic Life Support
- American Red Cross, Registered Nurse
- Illinois Department of Financial and Professional Regulation, Registered Nurse
- Missouri Division of Professional Registration

Research (2 Years), Nursing (2 Years)

Not Applicable

A Class E (MO) or Class D (IL) license and a good driving record are required for this position.