Senior Clinical Research Coordinator - Pediatrics Genetics

Washington University in St. Louis • Watervliet, MI

2d • $62,000 - $96,100

About The Position

A Senior Clinical Research Coordinator is sought for the Center for Rare, Undiagnosed, and Genetic Disorders. This highly skilled individual will be a main point of contact for investigators wishing to initiate n-of-1 or small clinical trials in rare and genetic diseases. This coordinator may also assist in interventional sponsored studies. This individual oversees and coordinates complex or multi-site clinical research studies; serves as a resource to provide comprehensive information to clinical research staff by promoting a smooth operation, preparation of regulatory compliance and interaction with other departments; may supervise clinical research staff.

Requirements

• 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
• Clinical Research (3 Years)
• Supervision

Nice To Haves

• Master's degree
• Clinical Research Management
• Clinical Study Protocols
• Database Management
• Research Projects
• Spreadsheet Analysis
• Statistical Analysis Software (SAS)

Responsibilities

• Acts as the primary liaison to PI in developing plans for research projects and discussing the interpretation of results; collaborates in the preparation of manuscripts for publication and preparation of grant proposals to sponsoring agencies; assists in the preparation of amendments to protocols and/or modifications to study design as appropriate.
• Serves as responsible for the development of forms, questionnaires and the application of research techniques; assists in writing instructional procedure manuals for study progress, data collection and coding; reviews journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies.
• Prepares sponsor-investigator INDs and assists PI and investigators in navigating regulatory requirements for investigator-initiated studies including emergency and individual IND studies as well as traditional IND studies.
• Designs, implements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies; identifies problems and/or inconsistencies and monitors participant’s progress to include documentation and reporting of adverse events; resolves IRB/protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency.
• Consents study participants, coordinates study visits alone or in collaboration with clinical research unit staff, IRB submissions including initial, continuing review, and ad hoc submissions for example adverse events (AE), responsible for AE reporting including Medwatch, communications with study monitors and data and safety monitoring boards, and other duties related to conduct of clinical trials.
• Provides guidance to members of research team in the implementation and evaluation of clinical research; trains new staff; may serve as lead or as point of reference for other research coordinators for questions, staff scheduling, feedback on performance.
• Evaluates and interprets collected clinical data in conjunction with PI as appropriate; prepares oral or written presentations or reports and analyses setting forth progress trends and provides recommendations or conclusions of the same.
• Performs other duties incidental to the work described above.

Benefits

• 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%.
• Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!
• We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We’ve got you covered.
• 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 with us.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees