Clinical Research Coordinator II - Pediatrics Clinical Research Unit

Washington University in St LouisSt Louis, WA
Onsite

About The Position

This position within the Pediatrics Clinical Research Unit (PCRU) assists investigators as a coordinator of complex clinical research studies. The role is responsible for managing multiple research studies simultaneously, acting as a liaison with the school, sponsoring agency, community, and study participants. The coordinator is responsible for managing and recording all phases of study protocols as required by the sponsoring agency to ensure compliance. The position will coordinate with multidisciplinary teams to maintain continuity of care while safeguarding human subjects and promoting research integrity.

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 (2 Years)
  • Basic Life Support 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 requirement).

Nice To Haves

  • Clinical Research
  • Clinical Study Protocols
  • Database Management
  • Research Projects
  • Spreadsheet Analysis
  • Statistical Analysis Software (SAS)

Responsibilities

  • Confers with PI to assist in developing plans for research projects and discuss the interpretation of results.
  • Collaborates in the preparation of manuscripts for publications and preparation of grant proposals to sponsoring agencies.
  • Assists in the preparation of amendments to protocols and/or modifications to study design as appropriate.
  • Coordinates 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.
  • Routinely implements and manages all phases of study/protocol including recruitment, enrollment and eligibility as well as informed consent.
  • 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 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 IRB/protocol management issues and recommends corrective action as appropriate.
  • Serves as liaison with funding or sponsoring agency.
  • 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 herein.

Benefits

  • Up to 22 days of vacation, 10 recognized holidays, and sick time.
  • Competitive health insurance packages with priority appointments and lower copays/coinsurance.
  • Free Metro transit U-Pass for eligible employees.
  • 4 weeks of caregiver leave to bond with your new child.
  • Family care resources are also available for your continued childcare needs.
  • Adult care resources.
  • 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.
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