Research Nurse Coordinator II - Gastroenterology (IBD)

Job description

Location SAINT LOUIS, MO 63110 Scheduled Hours 40 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. Job Description 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:Job Location/Working ConditionsNormal office environmentExposure to blood-borne pathogensRequires protective devicesPatient care settingDirect patient care settingPhysical EffortTypically sitting at desk or tableTypically bending, crouching, stoopingOccasional lifting (25 lbs or less)EquipmentOffice equipmentClinical/diagnostic equipmentThe above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are 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. Required Qualifications Education: Associate Degree In Nursing Or Diploma In Registered Nursing Certifications/Professional Licenses: The list below may include all acceptable certifications, professional licenses and issuers. More than one credential, certification or professional license may be required depending on the role. 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 Work Experience: Research (2 Years), Nursing (2 Years) Skills: Not Applicable Driver's License: A Class E (MO) or Class D (IL) license and a good driving record are required for this position. More About This Job Required Qualifications: • Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirements). 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. Preferred Qualifications Education: No additional education unless stated elsewhere in the job posting. Certifications/Professional Licenses: No additional certification/professional licenses unless stated elsewhere in the job posting. Work Experience: No additional work experience unless stated elsewhere in the job posting. 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), Nu