Washington University in St. Louis
Clinical Research Coordinator I (Data) - Medical Oncology
Washington University in St. Louis, St Louis, Missouri, United States
Clinical Research Coordinator
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. Responsible for helping the clinic coordinator and Principal Investigator (PI) manage and record data for all phases of study protocol as required by sponsoring agency to ensure compliance, patient safety and welfare, and data integrity. Assists investigators as coordinator of a basic to moderately complex clinical research study; may be responsible for multiple research studies simultaneously, acting as a liaison with the school, sponsoring agency, community and the study participants; responsible for managing and recording all phases of study protocol as required by the sponsoring agency to ensure compliance. Primary Duties & 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 Monitors participant's progress throughout study, which includes documentation and reporting of adverse events; resolves protocol management issues and recommends corrective action as appropriate; serves as liaison between WU study team, the sponsor, and Clinical Research Organization (CRO) Extracts clinical data from EMR and receives clinical data from other source documents and enters it in a study specific electronic data capture system (EDC) Assures protocol compliance and adherence by performance of quality control checks of collected data Evaluates all lab and clinical assessments to ensure they are completed correctly and per protocol specification. Reviews collected clinical data in conjunction with PI or sub-investigator as appropriate Frequently communicates with sponsors and CROs, and responds to queries. Facilitates sponsor monitoring visits (if applicable) 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) Implements and manages all phases of study/protocol; 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 to 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 Collects clinical data under clinical research protocols Performs other duties as assigned. Working Conditions: Patient care setting. Typically sitting at desk or table. Office equipment. Required Qualifications: Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirements). Preferred Qualifications: Clinical Research, Clinical Study Protocols, Communication, Computer Systems, Interpersonal Communication, Organizing, Research Support Grade: C09 Salary Range: $47,400.00 - $71,200.00/Annually For frequently asked questions about the application process, please refer to our External Applicant FAQ.
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. Responsible for helping the clinic coordinator and Principal Investigator (PI) manage and record data for all phases of study protocol as required by sponsoring agency to ensure compliance, patient safety and welfare, and data integrity. Assists investigators as coordinator of a basic to moderately complex clinical research study; may be responsible for multiple research studies simultaneously, acting as a liaison with the school, sponsoring agency, community and the study participants; responsible for managing and recording all phases of study protocol as required by the sponsoring agency to ensure compliance. Primary Duties & 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 Monitors participant's progress throughout study, which includes documentation and reporting of adverse events; resolves protocol management issues and recommends corrective action as appropriate; serves as liaison between WU study team, the sponsor, and Clinical Research Organization (CRO) Extracts clinical data from EMR and receives clinical data from other source documents and enters it in a study specific electronic data capture system (EDC) Assures protocol compliance and adherence by performance of quality control checks of collected data Evaluates all lab and clinical assessments to ensure they are completed correctly and per protocol specification. Reviews collected clinical data in conjunction with PI or sub-investigator as appropriate Frequently communicates with sponsors and CROs, and responds to queries. Facilitates sponsor monitoring visits (if applicable) 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) Implements and manages all phases of study/protocol; 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 to 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 Collects clinical data under clinical research protocols Performs other duties as assigned. Working Conditions: Patient care setting. Typically sitting at desk or table. Office equipment. Required Qualifications: Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirements). Preferred Qualifications: Clinical Research, Clinical Study Protocols, Communication, Computer Systems, Interpersonal Communication, Organizing, Research Support Grade: C09 Salary Range: $47,400.00 - $71,200.00/Annually For frequently asked questions about the application process, please refer to our External Applicant FAQ.