Clinical Research Coordinator I (Data) - Medical Oncology

About the role

The Position assists investigators as a data coordinator of clinical research trials of all complexities, extracting data from the Electronic Medical Record (EMR) and other source documents and entering it into an Electronic Data Capture (EDC).

May be responsible for numerous research trials simultaneously. Helps ensure the accurate collection of study-required procedures while patients are receiving protocol treatment and are in active protocol follow-up; acts as liaison between the School, trial sponsors, vendors, and the study team.

Responsibilities

• Manages patient-related data across all phases of clinical trials; ensures compliance with protocol guidelines and requirements of regulatory agencies; identifies procedural problems and/or inconsistencies.
• 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 protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency.
• Evaluates and interprets collected clinical data as appropriate; prepares oral or written presentations or reports and analyses setting forth progress trends and provides recommendations or conclusions of the same.
• Attends patient-related, protocol, and educational meetings. May prepare oral or written presentations related to patient updates or protocol training.
• Attends sponsor monitoring meetings with the PI (if applicable).
• Performs other duties incidental to the work described herein.

Requirements

• Manages patient-related data across all phases of clinical trials; ensures compliance with protocol guidelines and requirements of regulatory agencies; identifies procedural problems and/or inconsistencies.
• 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 protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency.
• Evaluates and interprets collected clinical data as appropriate; prepares oral or written presentations or reports and analyses setting forth progress trends and provides recommendations or conclusions of the same.
• Attends patient-related, protocol, and educational meetings. May prepare oral or written presentations related to patient updates or protocol training.
• Attends sponsor monitoring meetings with the PI (if applicable).
• Performs other duties incidental to the work described herein.

Qualifications

• Bachelor’s degree or combination of education and/or experience may substitute for minimum education.
• Basic Life Support certification (Online Basic Life Support certifications, those without a skills assessment component, are not sufficient to meet the Basic Life Support requirements).
• Preferred Qualifications: No additional education unless stated elsewhere in the job posting.
• Certifications/Professional Licenses: No additional certification/professional licenses unless stated elsewhere in the job posting.
• Work Experience: No additional work experience unless stated elsewhere in the job posting.
• Skills: Clinical Research, Clinical Study Protocols, Database Management, Research Projects, Spreadsheet Analysis, Statistical Analysis Software (SAS)

Benefits

Personal: 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: Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!

Family: We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. 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: https://hr.wustl.edu/benefits/

Equal Opportunity Employer