Scheduled Hours

40

Position Summary

This position will be housed in the Radiology Clinical Research Core (RadCore) working directly with the Center for Clinical Theranostics Research (CCTR) coordinating clinical trials.

Mallinckrodt Institute of Radiology’s clinical theranostics program provides personalized medical management through targeted radiopharmaceutical diagnosis and therapy. The theranostics program, which has been recognized as a Radiopharmarceutical Therapy Center of Excellence, is a collaboration between the Division of Nuclear Medicine and the Department of Radiation Oncology.

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.
• Ensures compliance with protocol guidelines and requirements of regulatory agencies; establishes record-keeping systems; makes assessments and determinations of participants’ progress in the study; resolves IRB/protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency.
• Assists in participant recruitment. Works with PI to develop recruitment plans and oversees the work of research assistants and technicians who recruit participants.
• Enters data or supervises the work of data entry staff. Utilizes RedCap and online Electronic Capture Data Forms.
• Coordinates collection and handling of specimens, processing, and shipping.
• Works with staff to identify, screen, and enroll study subjects; ensures labs, specimens, and data are obtained according to established protocol.
• Attends meetings and prepares study updates and review of data.
• Conducts clinical research visits. Administers patient research questionnaires, functional tests, cognitive testing.
• Completes necessary medical history. Completes adverse events reports and collects outside records.
• Works with study monitors to complete and query data.
• Performs other duties as assigned.

Working Conditions:

Job Location/Working Conditions

• Normal office environment

Physical Effort

• Typical sitting at a 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.

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