Additional Info

General Position Information

Department Name: Int Med Heart/Vascular CRO UNMC	Working Title: Clinical Study Coordinator
Holder Name:	FLSA Designation:
FTE:

Position Description Details

Responsibilities and Duties

RESPONSIBILITY	TIME SPENT PERCENTAGE	ESSENTIAL FUNCTION	TASKS
Coordination of Clinical Research Studies	60	X	Coordinate patient participation in investigational trials. Recruit and screen subjects; ensuring informed consent is obtained for assigned trials. (E); Prepare protocol submissions and continuing reviews for UNMC IRBs (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); Coordinate sponsor visits, preparing and obtaining case material for site visits. (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 (UneHealth, Sponsored Programs Administration/Accounting, Industry sponsors, Clinical Research Center, Neb Med ancillary Departments.)(E);
Data Collection	35	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).
Assist with other research activities	5	X	Assist other researchers, nurses, and medical/summer students involved in research trials (E); Other duties as assigned (E).

RESPONSIBILITY

TIME SPENT PERCENTAGE

ESSENTIAL FUNCTION

TASKS

Coordination of Clinical Research Studies

Coordinate patient participation in investigational trials.
Recruit and screen subjects; ensuring informed consent is obtained for assigned trials. (E);
Prepare protocol submissions and continuing reviews for UNMC IRBs (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);
Coordinate sponsor visits, preparing and obtaining case material for site visits. (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 (UneHealth, Sponsored Programs Administration/Accounting, Industry sponsors, Clinical Research Center, Neb Med ancillary Departments.)(E);

Data Collection

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).

Assist with other research activities

Assist other researchers, nurses, and medical/summer students involved in research trials (E);
Other duties as assigned (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 assisting in establishing budgets, submitting invoices, tracking payments and reconciling expenses.

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 protocols 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 (outpatient and inpatient)	All Levels of Contact	Daily	Coordinate, educate and perform functions related to clinical studies
Principal Investigators / Division Research Staff	Within Department	Daily	To coordinate study, receive direction, and provide feedback on the patients and study
Fellows, residents and students	Internal to UNMC	Daily	Educate and train rotating trainees in the study and its procedures
Various campus support and administrative personnel	Internal to UNMC	Daily	Perform various research support functions pertaining to the studies
Patients / Families	External to UNMC	Daily	To provide education, coordinate study, and perform procedures to carry out clinical study protocols
Representatives from Study sponsors and pharmaceutical companies	External to UNMC	Weekly	Address compliance and data needs as required

Supervision Received

Melissa Howard, Cardiovascular Clinical Research Nurse Administrator. Direct and 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:

Full extent of working environments TBD by academic and research 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: Occasionally (1-33%)	Bending: Occasionally (1-33%)
Stand: Occasionally (1-33%)	Kneeling: Occasionally (1-33%)
Walk: Occasionally (1-33%)	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 activity TBD by position duties

Lift, Carry, Push, Pull Activity

Lift: Occasionally (1-33%) 10 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 activities

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: 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 activities

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:

Full extent of protective equipment TBD by position activities

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 and Wrists TBD by position activities.

Sensory

Ability to Speak: YES	Depth Perception: YES
Hearing: NO	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: