Additional Info

General Position Information

Position Number: 00073223	Working Title: Research Nurse Coordinator I
Department Name: CHRI Administration UNMC	Reports To Title: Senior Research Manager

Position Description Details

Responsibilities and Duties

RESPONSIBILITY	TIME SPENT PERCENTAGE	ESSENTIAL FUNCTION	TASKS
Patient Care Management	50		1. Coordinate patient enrollment and recruitment, and screen patients for inclusion into study protocols. Ensure the treatment provided and the data collected adheres to study protocol. Assess health status by interviewing patients regarding medical history, performing physical examination, and psychosocial assessment. (E) 2. Provide preliminary evaluation in consultation with Principal Investigator and patient physician at time of treatment decision and to determine final eligibility for enrollment into research protocol. (E) 3. Assist with obtaining informed consent by explaining investigative trials, all tests and procedures to patient/family and address any questions/concerns. Provide in-depth description of clinical trial including purpose, treatment plan, potential risks, potential benefits, and financial obligations, and rights of the research subject. Provide overview and comparison of treatment options related to clinical trial vs. standard therapy.(E) 4. Responsible for coordination of research protocol and management of patient while patient is participating in clinical trial. Prepare physician orders; coordinate all diagnostic tests and procedures relevant to the study and follow-up to ensure the orders are carried out. Test results are reviewed with investigator and acted upon as directed. 5. Responsible for the randomization of patients to treatment arms. Responsible for monitoring patient health status during treatment. (E) 6. Responsible for placing all records including signed informed consent in patient chart and research record. 7. Responsible for obtaining study lab samples, preparation, and coordination of specimen shipment. 8. Meet with physicians, and other related personnel to explain new investigational trials, update ongoing trials or address any problems.(E)
Research Protocol Management	50		1. Assist Principal Investigator by writing and submitting application and/or protocol to the IRB and Pharmacy and Therapeutics Committee, when new trials are initiated. Submit modifications to the protocol, IRB application, informed consents as needed during the course of the investigation. (E) 2. Prepare continuing reviews, internal and external adverse events and other reports to the IRB, SRC, FDA, and sponsoring agency as required. (E) 3. Responsible for coordinating and initiating research protocol with study sponsor, investigational pharmacy, nursing staff, and other UNMC departments affected by the research protocol and its requirements. (E) 4. Provide education to staff related to the protocol. (E) 5. Responsible for data collection including case report forms specific to study sponsor and/or institutional required data. (E) 6. Accurately interpret and record data to ensure that research results are error free.(E) 7. Maintain regulatory documentation as appropriate to meet federal and sponsoring agency guidelines.(E) 8. Develop data collection instruments (paper and computerized) as needed. Interpret, extract and record information from source documents and patient interview for support of clinical research. Provide reports to investigator and sponsor (listing and statistical) as requested.(E) 9. Attends Sponsor support study start up meetings. (E) 10. Act as back up to other coordinators within the Pediatric Research Office as necessary. (E) 11. Other duties as assigned.

Zone Definition Factors

Problem Solving - Decision Making

Problem solving and decision making is an overriding job requirement.

Impact

The overall correctness of the work is typically determined over a period of months.

How quickly is the overall correctness of the work of an incumbent in this position typically determined?:

Determined over a period of months

Include budget dollars, value of assets, and impact in terms of organizational exposure to risk/liability.

Describe the budgetary accountabilities for this position:

Determines patient expenses as related to each study. Provides input to PRO finance team to aid in development of study budget.

What impact do the decisions/recommendations made by the position have on the department/campus?:

Direct impact to department – studies are administrated as required
Direct impact to campus – Correctness in handling of previous studies could determine additional studies awarded to UNMC.

Contacts and Communications

TYPE OF CONTACT	LEVEL OF CONTACT	FREQUENCY OF CONTACT	PURPOSE OF CONTACT
Study Participants	All Levels of Contact	Daily	Educates and coordinates patient treatment as directed by the study protocol
Study sponsors	External to UNMC	Weekly	Management and conduct of clinical research studies according to sponsor requirements
Regulatory Affairs Office	Internal to UNMC	2-3 times a week	IRB completion and submission
CHRI Administration	Within Department	2-3 times a week	Coordination of Clinical Trial
CHRI Faculty and Clinical Staff	All Levels of Contact	2-3 times a week	Coordination and execution of clinical trial studies

Supervision Received

Supervisor is on campus and has direct access to this person.

Supervision Exercised

Does this position supervise?:

Type of Supervision Exercised:

N/A

Work Environment & Physical Demands

Working Environment

Office,Lab,Clinical

Patient Care and Contact - Age Specific Competency

Check the appropriate box(es) that describes the Age Specific population(s) served within the scope of this position.

Pre-term/Neonate (birth - 6 wks),Infant (6 wks - 12 months),Toddler (1-3 years),Pre-School (3-6 years),School Age (6-12 years),Adolescence (12-18 years)

Activity Frequency

Sit: Frequently (34-66%)	Bending: Occasionally (1-33%)
Stand: Occasionally (1-33%)	Kneeling: Not Required
Walk: Occasionally (1-33%)	Reaching: Occasionally (1-33%)
Drive Motor Vehicle: Occasionally (1-33%)	Crawling: Not Required
Squatting: Not Required	Climbing: Not Required

If other, please explain:

N/A

Lift, Carry, Push, Pull Activity

Lift: Occasionally (1-33%) 11 - 20 lbs	Push: Occasionally (1-33%) 11 - 20 lbs
Carry: Occasionally (1-33%) 11 - 20 lbs	Pull: Not Required Not Applicable

If other Lift, Carry, Push, Pull, please explain:

N/A

Exposure

Animals (Category 1): NO	Moving Machinery: NO
Animals (Category 3): NO	Biohazardous Material: NO
Blood & Bloody Fluids: YES	Uncomfortable temperature/ humidity: NO
Radiation/ Radioactive: NO	Noise: NO
Chemical Hazards: YES	Working from Heights: NO
Electrical Hazards: NO	Confined Space: NO
3B or Class 4 Laser: NO	Dust and Dusty environments: NO
Hot Work: NO

If other exposure, please explain:

N/A

Use of Protective Equipment

Hearing Protection: NO	Eye Protection: NO
Half or Full Face Reusable Respirator: NO	Protective Clothing: NO

If other protection, please explain:

Follow universal masking policy in times of pandemic as directed by campus leaders

Use of Hands/ Wrists

Keyboard: YES	Pipefitting: NO
Fine Manipulation: YES	Grasping: YES
Repetitive Motion: NO

If other use of hands/ wrists, please explain:

N/A

Sensory

Ability to Speak: YES	Depth Perception: YES
Hearing: YES	Distant Vision: YES
Sight: YES	Near Vision: YES
Color Vision: YES	Peripheral Vision: YES

Emergency Conditions

During emergency conditions due to severe weather, natural disasters, major utility failures, or other unplanned events, certain personnel are activated to minimizethe impacts of emergencies and disasters, and to protect people, property, and restore the primary mission of the University of Nebraska Medical Center.These personnel occupy positions which are designated as 'Essential Positions.'

Essential: