Clinical Research Coordinator II - Orthopedic Surgery

at  Washington University School Of Medicine

POSITION SUMMARY

Position assists investigators as coordinator of a semi-complex clinical research study; may be responsible for 3 to 5 investigators 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 sponsoring agency to ensure compliance

EDUCATION:

Bachelor’s degree or combination of education and/or experience may substitute for minimum education.

WORK EXPERIENCE:

Clinical Research (2 Years)

SKILLS:

Not Applicable

REQUIRED QUALIFICATIONS

• Basic Life Support certification must be obtained within one month of hire date.
• 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).

EDUCATION:

No additional education beyond what is stated in the Required Qualifications section.

WORK EXPERIENCE:

No additional work experience beyond what is stated in the Required Qualifications section.

SKILLS:

Clinical Research, Clinical Study Protocols, Database Management, Research Projects, Spreadsheet Analysis, Statistical Analysis Software (SAS)

• Confers with PI to assist in developing plans for research projects and discuss 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; identifies problems and/or inconsistencies and monitors participant’s progress to include documentation and reporting of adverse events; resolves IRB/protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency
• Evaluates and interprets collected clinical data in conjunction with PI 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 incidental to the work described herein