Clinical Research Coordinator I - Pediatrics Hematology & Oncology

Washington University in St. Louis • Ann Arbor, MI

1d • Onsite

About The Position

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.

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
• No specific work experience is required for this position.
• Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirements).

Nice To Haves

• Clinical Research
• Clinical Study Protocols
• Communication
• Computer Systems
• Interpersonal Communication
• Organizing
• Research Support

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 participants’ 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 clinical staff with consenting participants for non-therapeutic clinical trials; assists clinical staff in administering patient reported outcome surveys and other participant questionnaires.
• Performs other duties as assigned.

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: Entry Level