Clinical Research Coordinator I - Pediatrics Gastroenterology

CP00001 Washington University in St Louis; United States; Sur place; USD 49 000 - 74 000; Plein temps

Résumé du poste

The Holtz lab at Washington University School of Medicine is seeking a research coordinator to manage a complex observational clinical study on maternal-offspring microbiome. The role focuses on coordinating study procedures, recruiting participants, obtaining informed consent, and ensuring compliance with IRB/IACUC guidelines, data entry, and collaboration with clinical staff.

The candidate should be detail-oriented, possess excellent communication skills, have a flexible schedule including

Qualifications

• Bachelor’s degree or equivalent required.
• BLS certification required by AHA/Red Cross.
• No specific prior work experience required.
• Preference for candidates with research coordination experience.

Responsabilités

• Coordinate all phases of the study and ensure regulatory compliance.
• Recruit and enroll participants; obtain informed consent.
• Schedule and monitor visits; collect data; liaise with IRB/IACUC.
• Prepare reports and assist with data analysis and adverse event reporting.
• Collaborate with clinical staff and other departments; maintain records.

Connaissances

Clinical Research

Clinical Study Protocols

Communication

Interpersonal Communication

Organizing

Research Support

Computer Systems

Formation

Bachelor’s degree

Basic Life Support certification

Description du poste

Location & Hours

Location SAINT LOUIS, MO 63110

Scheduled Hours 40

Position Summary

The Holtz lab is seeking help with a complex observational clinical study at Washington University School of Medicine. The Maternal Offspring Microbiome (MOM) study aims to understand how the infant gut is first populated with bacteria and viruses. We are interested in defining if babies obtain their microbiome from their environment, from the people who care for them, or from their pets.

Role Overview

In this position, you will coordinate a complex clinical research study; serve as a resource to provide comprehensive information to clinical staff by promoting a smooth operation, prepare regulatory compliance and interact with other departments. You will work closely with other team members and healthcare professionals to recruit and enroll study participants, explain the purpose of study and obtain informed consent from participants, conduct study visits in the hospital and the participant’s home, ensure compliance with protocol guidelines and requirements of the IRB and IACUC, enter data, and assist with lab procedures.

Preferred applicants are detail orientated, clear communicators, able to provide their own transportation to study visits, curious, enthusiastic, have a flexible schedule (availability needed some weekends, evenings, and early mornings), and have experience with REDCap, Excel, and EPIC. You may be responsible for multiple research studies simultaneously.

Primary Duties & Responsibilities

• Implements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies; establishes record-keeping systems; makes assessments and determinations of participants’ progress in the study; analyzes, investigates and reports adverse events; makes decisions as to when to notify physicians of issues, when to stop participant inclusion and/or to make and/or recommend adjustment of the protocol of particular participants; resolves protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency.
• Recruits and enrolls study participants; makes and/or participates in making determinations of eligibility based on diagnostic criteria and/or observations/analysis in participant interviews; develops informed consent packets for study participants and confers with participants to explain purpose of study and obtain completed informed consent packets; explains diagnostic procedures and treatment plans to address participant/family concerns; administers/scores tests and/or evaluates all lab and clinical assessments to ensure they are completed in a timely manner.
• Ensures timely completion of all protocol requirements (assessment, lab testing, procedures and treatments), to include scheduling and facilitating the patient’s timely completion of protocol requirements; evaluates and interprets collected clinical data as appropriate; prepares oral or written presentations or reports and analyses setting forth progress trends and provides recommendations or conclusions of the same.
• Collects clinical data under clinical research protocols.
• Performs other duties as assigned.

Working Conditions

Job Location/Working Conditions Patient care setting.

Physical Effort Typically sitting at desk or table.

Equipment Office equipment.

The 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: Bachelor’s degree or combination of education and/or experience may substitute for minimum education.
• Basic Life Support - American Heart Association
• Basic Life Support - American Red Cross
• Work Experience: No specific work experience is required for this position.
• Skills: Not Applicable
• Driver's License: A driver's license is not 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

• 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: Clinical Research, Clinical Study Protocols, Communication, Computer Systems, Interpersonal Communication, Organizing, Research Support

Salary

Grade C09 Salary Range $49,200.00 - $73,800.00 / Annually The salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.

Questions

Questions For frequently asked questions about the application process, please refer to our External Applicant FAQ.

Accommodation

If you are unable to use our online application system and would like an accommodation, please email [e-mail] or call the dedicated accommodation inquiry number at 314-935-1149 and leave a voicemail with the nature of your request. All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.

Pre-Employment Screening

All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.

Benefits Statement

Up to 22 days of vacation, 10 recognized holidays, and sick time. Competitive health insurance packages with priority appointments and lower copays/coinsurance. Take advantage of our 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%.