Location

St. Louis, MO 63110

Scheduled Hours

40

Position Summary

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.

Job Description

• 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). Performs other duties incidental to the work described herein

• Assists in developing plans for research projects and discusses the interpretation of results; collaborates in the preparation of manuscripts for publications and preparation of grant proposals to sponsoring agencies; assists in the preparation of amendments to protocols and/or modifications to study design as appropriate.

• Coordinates the development of forms, questionnaires and the application of research techniques; assists in writing instructional procedure manuals for study progress, data collection and coding; reviews journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies.

• 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 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.

• Performs other duties as assigned.

Working Conditions:
Job Location/Working Conditions

• Patient care setting.
   

Physical Effort

• Typically sitting at desk or table.
   

Equipment

• Office equipment.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.

Required Qualifications