Scheduled Hours

40

Position Summary

A Clinical Research Coordinator III is sought for the Center for Rare, Undiagnosed, and Genetic Disorders. This highly skilled individual will be a main point of contact for investigators wishing to initiate n-of-1 or small clinical trials in rare and genetic diseases. This coordinator may also assist in interventional sponsored studies.

This individual oversees and coordinates complex or multi-site clinical research studies; serves as a resource to provide comprehensive information to clinical research staff by promoting a smooth operation, preparation of regulatory compliance and interaction with other departments; may supervise clinical research staff.

Job Description

• Acts as the primary liaison to PI in developing plans for research projects and discussing the interpretation of results; collaborates in the preparation of manuscripts for publication and preparation of grant proposals to sponsoring agencies; assists in the preparation of amendments to protocols and/or modifications to study design as appropriate.
• Serves as responsible for 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.
• Prepares sponsor-investigator INDs and assists PI and investigators in navigating regulatory requirements for investigator-initiated studies including emergency and individual IND studies as well as traditional IND studies.
• Designs, 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.
• Consents study participants, coordinates study visits alone or in collaboration with clinical research unit staff, IRB submissions including initial, continuing review, and ad hoc submissions for example adverse events (AE), responsible for AE reporting including Medwatch, communications with study monitors and data and safety monitoring boards, and other duties related to conduct of clinical trials.
• Provides guidance to members of research team in the implementation and evaluation of clinical research; trains new staff; may serve as lead or as point of reference for other research coordinators for questions, staff scheduling, feedback on performance.
• 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 above.

Working Conditions:

Job Location/Working Conditions

• Normal office environment

Physical Effort

• Typically sitting at a desk or a 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 (3 Years)

Skills:

Not Applicable

Driver's License:

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

More About This Job

Required Qualifications

• BLS certifi