Clinical Research Coordinator II - Surgery Oncology

at  Washington University School Of Medicine

POSITION SUMMARY

Position assists investigators and study team as coordinator of the Washington University Participant Engagement and Cancer Genome Sequencing (WU-PE-CGS) program; 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
This position will assist with recruitment of participants from Siteman Cancer Center. (S)he will work closely with clinic staff to maintain consistent procedures across sites and coordination of data collection from patients. The Clinical Research Administrator will be responsible for patient consenting for tissue acquisition under our HRPO/IRB approved protocol. This position will also be responsible for maintaining all regulatory requirements (Hospital, Cancer Center, NIH, and IRB) to comply with human research study rules and regulations.
The position will work with the lead Research Nurse in coordinating and performing the duties of the Participant Engagement Unit (PEU). The PEU will be responsible for direct participant engagement to enroll patients into the Washington University (WU) PE-CGS program. Under the direction of PIs Fields and Drake, the Clinical Research Coordinator will work to manage and record large amounts of data and meta data for study participants and to the program.

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)

• 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.