Clinical Research Coordinator I - Pediatrics Gastroenterology at Washington University in St Louis in Washington, DC

Job description

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. 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. Job Description 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. Certifications /Professional Licenses : The list below may include all acceptable certifications, professional licenses and issuers. More than one credential, certificatio