Clinical Research Coordinator III - Pediatrics Genetics

Clinical Research Coordinator III

A Clinical Research Coordinator III 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.

Primary Duties & 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.

Working Conditions:

• Normal office environment
• Typically sitting at a desk or a table
• 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 : Basic Life Support - American Heart Association, Basic Life Support - American Red Cross
• Work Experience: Clinical Research (3 Years)

More About This Job:

• BLS certification must be obtained within one month of hire date.
• Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirements).
• Optional Based on Department) SOCRA/ACRP certification.

Preferred Qualifications:

• Education: Master's degree
• Certifications /Professional Licenses : No additional certification/professional licenses unless stated elsewhere in the job posting.
• Work Experience: Lead Position (1 Year)
• Skills: Clinical Research Management, Clinical Study Protocols, Database Management, Research Projects, Spreadsheet Analysis, Statistical Analysis Software (SAS), Supervision

Grade: C11

Salary Range: $56,200.00 - $87,100.00 / 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.

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%.
• 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.

For policies, detailed benefits, and eligibility, please visit:

EEO Statement:

Washington University in St. Louis is committed to the principles and practices of equal employment opportunity. It is the University's policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, citizenship (where prohibited by federal law), age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.

Washington University in St. Louis