Scheduled Hours

40

Position Summary

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.
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. The regulatory coordinator’s responsibilities are to keep the studies’ regulatory statuses up-to-date, obtain necessary information to submit to the IRB and other regulatory bodies to maintain compliance with various rules, laws, regulations and policies at each stage of a clinical study.

Job Description

Primary Duties & Responsibilities:

• Assists in developing plans for research projects and discusses the interpretation of results; writes and prepares Institutional Review Board (IRB) regulatory submissions, 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.
• Coordinates submissions to ancillary committees such a Protocol Review and Monitoring Committee, Radioactive Drug Research Committee, and Institutional Biological and Chemical (IBC) Safety Committee.
• 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:

The list below may include all acceptable certifications and issuers. More than one credential or certification 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 must be obtained within one month of hire date.
• Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirement).

Preferred Qualifications

Education:

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

Certifications:

No addition