Clinical Research Coordinator II (Regulatory/Remote) - Medical Oncology

Position Summary

Clinical research is a heavily regulated field. It is regulated at the federal level by the Department of Health and Human Services, Office of Human Research Protections, the Food and Drug Administration, the Office of Civil Rights, to name a few. There are state and local rules, regulations and statutes that may impact the conduct of clinical research. In addition, institutional policies from the University, School of Medicine and the Division also come into play. Position assists investigators as coordinator of a 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 sponsoring agency to ensure compliance

Job Description

Primary Duties & Responsibilities:

• 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

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

Certifications/Professional Licenses:
The list below may include all acceptable certifications, professional licenses and issuers. More than one credential, certification or professional license may be required depending on the role. Basic Life Support - American Heart Association, Basic Life Support - American Red Cross

Work Experience:
Clinical Research (2 Years)

Skills:
Not Applicable

Driver's License:
A driver's license is not required for this position.

More About This Job

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

Preferred Qualifications

Education:
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)

Grade

C10

Salary Range

$52,600.00 - $78,900.00 / Annually
The salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.

Scheduled Hours

40