RN - Clinical Research Nurse

Department/Unit:

Emergency Medicine General

Work Shift:

Day (United States of America)

Salary Range:

$78,773.63 - $122,099.12

The Clinical Research RN is expected to provide organizational and management support for multiple clinical trials and other studies. The position is accountable for assisting in the timely and accurate conduct of research studies, from initiation to completion of study, with an emphasis on flexibility that priorities certain studies depending on the current needs of the research division of the Department of Emergency medicine.

The Clinical Research RN works with study participants in various study tasks including patient recruitment, screening for eligibility, scheduling, physical assessments and biospecimen collection and processing, as well as data collection and study completion activities.

Responsibilities and Duties include:

• Complete and submit protocol specific research site information, conflict of interest, financial disclosure, and confidentiality forms as appropriate

• Determine feasibility of study considering, appropriateness for patient population, maintenance of subject safety and confidentiality, fiscal soundness, and logistical capabilities as appropriate

• Knowledgeable on each protocol’s specific inclusion, exclusion, therapy, clinical monitoring oversight, laboratory evaluation, safety monitoring and data management requirements

• Communicate and interact with PI, research team, sponsor, IRB, WIRB, Research Administration, appropriate AMC departments (compliance, finance, faculty practice, pharmacy, radiology, laboratory medicine etc.) as appropriate

• Communicate and interact with NIH/NCI cooperative groups, pharmaceutical companies, clinical research organizations (CRO’s), and site research organizations (SRO’s) as appropriate

• Prepare site for initiation of study by coordinating initiation and training site visits, and preparing documents, clinical units, administrative space and personnel for the study as appropriate

• Prepare and submit forms to establish research cost center - Departmental signature forms, Compliance checklist, Subject budget form, and Unrelated Income tax form

• Prepare and submit forms to establish G99 research billing accounts with PBS and MCPG

• Prepare AMCH and AMC Practice Research Patient Registration forms

• Comply with all regulatory agency requirements and protocol guidelines in implementing clinical trials

• Complete mandated protocol training – electronic case report system, study specific equipment, study specific point of care testing, and scales/scoring.

• Develop original source data documents

• Coordinate and conduct recruitment efforts, in-service education and screening programs

• Prepare and coordinate advertisement and media coverage efforts with appropriate AMC departments

• Conduct informed consent process; obtain consent and HIPAA authorization

• Register patient as study subject with sponsor

• Create and maintain subject screening and enrolment logs, delegation of duty logs, adverse event logs

• Contact sponsor randomization system or request AMCH pharmacy to randomize subject as appropriate

• Coordinate and conduct screening visits, develop study schedule, timelines, and deadlines with study patient/family, the PI and research team.

• Perform health assessment procedures as required by the protocol and as ordered by the PI (e.g., EKG, urinalysis, urine pregnancy testing, vital signs, obtain specimens etc.)

• Administer/perform study scales and questionnaires

• Perform patient navigation, which includes but is not limited to:  identifying patients who screen positive on various tests; scheduling patients for followup; reminding patients about their appointments; confirming that patients went to their followup appointment; and providing education to patients.

• Coordinate and work with AMCH and AMC Faculty Practice registration staff to schedule follow-up study visits, treatments, testing and procedures appointments

• Coordinate dispensing of study therapy through the AMCH pharmacy as appropriate

• Ensure safety of study specific medical equipment used with research subjects, (e.g. EKG machine) via referral to Clinical Engineering; is prepared for emergencies, equipment failure, user errors and reports such events to management.

• Complete and maintain accurate source data documentation

• Communicate on a continuous basis with subjects and families to monitor for adverse effects

• Ensures safety of subjects in the case of adverse and serious adverse events, recog