Scheduled Hours

40

Position Summary

This position will be in the Center for Clinical Services (CCS). The CCS is a centralized office that supports effective, efficient, and reliable evaluation of new pharmaceuticals and medical devices in collaboration with sponsoring organizations (industry and/or government).

This position will support multiple clinical research studies on day-to-day clinical trial activities such as patient recruitment, data collection and entry, patient education, ensuring regulatory compliance, and maintaining accurate documentation of research activities. Collaborates with principal investigators and physicians to provide support with examinations, procedures and other processes related to direct patient care. These duties include IV placement and investigational drug infusions, lab draws, patient assessments, and vital signs. Acts as liaison by facilitating communication and coordination of care between patients, families and health team members; explains routines and procedures, in accordance with study protocols, to patients and coordinates patient care information to appropriate sources. Assists research associates from sponsoring organizations, providing study explanations and reports as necessary.

Job Description

Primary Duties & Responsibilities:

• Works under the principal investigator’s guidance to meet the research objectives of the project.
• Provides direct patient care, including assessment, planning, implementation and evaluation of patients; documents, collects data and assists physicians.
• Works with staff to identify, screen and enroll study subjects; ensures lab and data are obtained according to established protocol.
• Prepares/submits event reports in adherence with study procedures, budget and established guidelines.
• Assists research associates from sponsoring organization, providing study explanations and reports as necessary.
• Collects basic health information as required by protocol.
• Performs clinical study visits and schedules patients for exams and tests in accordance with study protocol. Performs vital signs, blood draws, various tests and minor procedures according to protocol and within direction of PI and personal skill set.
• Helps implement and independently performs research study and clinical procedures including assessment, planning, implementation, and evaluation of participants to generate study data according to established protocol; collects data (e.g., basic health information and vital signs), may perform blood draws and minor procedures according to protocol and within the direction of PI and personal skill set; documents processes as required by protocol; monitors and manages participants in the Clinical Translational Research Unit; assists principal investigators and physicians.
• Serves as the contact person for research participants; provides study participants, families, and caregivers education about the studies, dementia, and dementia care.
• Coordinates handling of specimens, administration of clinical trials, collection of source information, case reporting, and participant payments.
• 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.

Working Conditions:
Job Location/Working Conditions

• Normal office environment
• Exposure to blood-borne pathogens
• Requires protective devices
• Patient care setting
• Direct patient care setting

Physical Effort

• Typically sitting at desk or table
• Typically standing or walking
• Typically bending, crouching, stooping
• Occasional lifting (25 lbs or less)

Equipment

• Office equipment
• Clinical/diagnostic 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

Ed