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Washington University of St. Louis Clinical Research Coordinator I - Pediatrics Hematology/Oncology - 50658 in St. Louis, Missouri

Job Type/Schedule

This position is full-time and works approximately 40 hours per week.

Department Name/Job Location

This position is in the Department of Pediatrics Hematology/Oncology. The position is located at the Northwest Tower. This position is for the Medical School Campus.

Essential Functions

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.

PRIMARY DUTIES AND RESPONSIBILITIES:

  1. Routinely implements and manages all phases of study/protocol
  2. Enrolls study participants
  3. Participates in making determination of eligibility based on diagnostic criteria
  4. Prepares informed consent packets for study participants
  5. Ensures compliance with protocol guidelines and requirements of regulatory agencies
  6. In collaboration with the treating investigator, makes assessments and determinations of participants’ progress in the study
  7. Extracts data accurately from source documents and reports in various data entry systems within the protocol deadlines
  8. Notify appropriate personnel regarding the ordering and administration of investigational agents
  9. Investigates, analyzes, and reports adverse events
  10. Identifies challenges and consults supervisor regarding inclusion, exclusion and monitors for protocol compliance
  11. Assists in identification IRB and protocol management issues and recommends corrective action as appropriate
  12. 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
  13. Works with audit teams during institutional site visits
  14. Ships research samples when needed
  15. 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.
  16. 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.
  17. 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.
  18. Performs other duties as assigned.

Required Qualifications

Bachelor’s degree required; 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.

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.

Salary Range

The hiring range for this position is $43,326 - $54,205 annually.

Pre-Employment Screening

All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. Current employees applying for a new position within the university may be subject to this requirement. The screenings will include a criminal background check and, as applicable for the position, other background checks, drug screen, 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

This position is eligible for full-time benefits. Please click the following link to view a summary of benefits: https://wustl.box.com/s/8wkhs25yssf0775x9d6nd6vqa7obpth7.

EOE Statement

Washington University is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, genetic information, disability, or protected veteran status.

Job Title: Clinical Research Coordinator I - Pediatrics Hematology/Oncology - 50658

Job ID: 50658

Location: Medical School

Full/Part Time: Full-Time

Regular/Temporary: Regular

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