Additional Info

General Position Information

Position Number: 00071348	Working Title: Clinical Study Coordinator
Department Name: Int Med FPBCC Clin Trials Office UNMC	Reports To Title: Research Nurse Manager

Position Description Details

Responsibilities and Duties

RESPONSIBILITY	TIME SPENT PERCENTAGE	ESSENTIAL FUNCTION	TASKS
Coordination of Clinical Research Studlies	90	X	Coordinate patient participation in investigational trials. Recruit and screen subjects; ensuring informed consent is obtained for assigned trials. (E) Educate subjects regarding the study, schedule clinical visits and procedures under the direction of the PI. (E) Coordinate the collection and testing of laboratory samples, including shipping to off-site laboratories. (E) Develop administrative procedures necessary for clinical sites, as well as maintain the manual of operations and procedures. (E) Ensure compliance with protocol guidelines and requirements for regulatory agencies. (E) Serve as liaison between internal departments and external entities for regulatory and protocol compliance. (E) Assist other researchers, nurses, CRAs and Lead Nurses involved in research trials (E) Other duties as assigned.
Data Collection	10	X	Collect, document, and organize study related information. (E) Design and develop data collection tools, complete case report forms, and various forms to use for screening, data collection, data entry, and data set management. (E) Audit data and create reports. (E)

Zone Definition Factors

Impact

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

Determined within a relatively short period of time

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

Describe the budgetary accountabilities for this position:

Responsible for submitting invoices, tracking payments related to patient reimbursement.

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

This person’s decision-making and problem-solving skills can directly affect the health and well-being of study patients. In addition, the protocol procedures performed, and the data collected will have a significant impact on the validity of the study results.

Contacts and Communications

TYPE OF CONTACT	LEVEL OF CONTACT	FREQUENCY OF CONTACT	PURPOSE OF CONTACT
Campus Clinical Personnel (out patient and inpatient)	All Levels of Contact	Daily	Coordinate, educate and perform functions related to clinical studies
Patients / Families	External to UNMC	Daily	To provide education, coordinate study, and perform procedures to carry out clinical study protocols
Principal Investigators / Division Research Staff	Within Department	Daily	To coordinate study, receive direction, and provide feedback on the patients and study
Representatives from Study sponsors and pharmaceutical companies	External to UNMC	Weekly	Address compliance and data needs as required
Various campus support and administrative personnel	Internal to UNMC	Daily	Perform various research support functions pertaining to the studies

Supervision Received

Research Nurse Manager, Susan Blumel, Direct, Daily

Supervision Exercised

Does this position supervise?:

Type of Supervision Exercised:

Work Environment & Physical Demands

Working Environment

Office,Clinical

If Other/Combined Environment, please explain:

The full extent of the environment TBD by position activities.

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.

Adult (18-65 years),Geriatric (65 and older)

Activity Frequency

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

If other, please explain:

Full extent of activities TBD by position duties.

Lift, Carry, Push, Pull Activity

Lift: Occasionally (1-33%) 11 - 20 lbs	Push: Occasionally (1-33%) 10 lbs
Carry: Occasionally (1-33%) 10 lbs	Pull: Occasionally (1-33%) 10 lbs

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

Full extent of lift/carry/push/pull TBD by position duties.

Exposure

Animals (Category 1): NO	Moving Machinery: NO
Animals (Category 3): NO	Biohazardous Material: YES
Blood & Bloody Fluids: YES	Uncomfortable temperature/ humidity: NO
Radiation/ Radioactive: NO	Noise: NO
Chemical Hazards: NO	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:

Full extent of exposure TBD by position duties.

Use of Protective Equipment

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

If other protection, please explain:

Full extent of protective equipment TBD by position duties.

Use of Hands/ Wrists

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

If other use of hands/ wrists, please explain:

Full extent of hands/wrists TBD by position duties.

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: