Scheduled Hours

40

Position Summary

Position assists investigators as coordinator of moderately complex clinical research studies by managing enrollments, data, and research compliance needs related to Pediatric Hematology/Oncology. Position is responsible for multiple research studies simultaneously, acting as a liaison with the investigators, treating teams, pharmacy, laboratories, IRB, sponsors, and sponsor agencies. Position is responsible for managing and recording all phases of study protocol as required by sponsoring agency to ensure compliance.

Job Description

Primary Duties and Responsibilities

Routinely implements and manages all phases of study/protocol.

• Enrolls study participants.
• Participates in making determination of eligibility based on diagnostic criteria.
• Prepares informed consent packets for study participants.
• Ensures compliance with protocol guidelines and requirements of regulatory agencies.
• In collaboration with the treating investigator, makes assessments and determinations of participantsâ™ progress in the study.
• Extracts data accurately from source documents and reports in various data entry systems within the protocol deadlines.
• Notifies appropriate personnel regarding the ordering and administration of investigational agents. Investigates, analyzes, and reports adverse events.
• Makes decisions as when to notify physicians of issues, stop participant inclusion, and monitors for protocol compliance.
• Assists in the resolution of IRB and protocol management issues and recommends corrective action as appropriate.
• Serves as a liaison between institutional investigators, Human Research Protection Office, Operations Office, Siteman Cancer Center, Pharmaceutical Companies, Sponsoring Agencies, Center for Clinical Trials, and Patient Oriented Research Unit in Pediatrics.
• Works with audit teams during institutional site visits.
• Ships research samples when needed.

Performs weekend/holiday call approximately once every 2-3 months for serious adverse event reporting for study participants; attends clinic and inpatient rounds to assist in study patient related concerns.

Facilitates communication with investigators to ensure that study objectives are met in a timely manner; assists Senior Clinical Research Coordinators in alerting investigators and appropriate personnel of communications regarding adverse drug reaction reports and changes to protocols.

Assists with the timely submission of protocol documentation to the Human Research Protection Office and timely submission of all regulatory essential documentation to the sponsoring agencies.

Processes tumor tissue samples for clinical research studies.

Performs other duties as assigned.

Preferred Qualifications

• Experience in Pediatrics and/or Oncology.
• Working knowledge of computer programs and systems.
• Communication, organizational and interpersonal skills. 
• Working knowledge of techniques and methodologies used in developing, coordinating, and managing clinical research projects with working knowledge of database and spreadsheet management.

Required Qualifications

Bachelorâ™s degree; prior work experience, preferably in clinical research support, is highly preferred; a combination of relevant work and education equaling four years may substitute for this requirement.

Grade

C09

Salary Range

$44,200.00 - $66,400.00 / 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.

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

Washington University in St. Louis is committed to providing a comprehensive and competitive benefits package to our employees. Benefits eligibility is subject to employment status, full-time equivalent (FTE) workload, and weekly standard hours. Please visit our website at https://hr.wustl.edu/benefits/ to view a summary of benefits.

EEO/AA Statement

Washington University is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to an individualâ™s sex, race, color, religion, age, disability status, protected veteran status, national or ethnic origin, gender identity or expression, sexual orientation. Women, minorities, protected veterans and the disabled are strongly encouraged to apply.

Diversity Statement

Washington University is dedicated to building a diverse community of individuals who are committed to contributing to an inclusive environment â“ fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.

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