Additional Info

General Position Information

Position Number: 00071769	Working Title: Clinical Study Coordinator
Department Name: Neurological Sciences UNMC	Reports To Title: Professor
FLSA Designation:	Union:

Position Description Details

Responsibilities and Duties

RESPONSIBILITY	TIME SPENT PERCENTAGE	TASKS
Patient Care/Subject Coordination	40	1 Recruit and screen patients, and ensure informed consent is obtained. ( E) 2 Obtain blood samples, cultures, tissues, and other specimens for lab analysis. ( E) 3 Perform other testing as appropriate, including cognitive testing and ECG. ( E) 4 Coordinate research protocols including arranging necessary appointment and procedures, working collaboratively with other departments and institutions. ( E) 5 Coordinate subject visit scheduling per established protocols. ( E) 6 Complete required documentation and electronic record submission timely. ( E) 7 Process and ship laboratory specimens as necessary. ( E)
Award Administration and Execution	35	1. Assist in the determination of guidelines for the collection of clinical data. ( E) 2. Collect, compile, document and analyze clinical research data. ( E) 3. Coordinate the development of forms, questionnaires, and applications of research techniques, assist in the writing procedure manuals for data collection. ( E) 4. Coordinate and implement procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests, and other sources. ( E) 5. Identify problems and /or inconsistencies and monitor patient progress to include documentation and reporting or adverse events; recommend and coordinate action as appropriate. ( E) 6. Assist in the preparation of amendments to protocols and /or modifications to study design as appropriate. ( E) 7. Complete study closeout activities. ( E) 8. Other Duties as Assigned
Administration/Coordination of Clinical Research Studies	15	1. Provide clinical research administrative coordination and award management. ( E) 2. Helps identify study team members needed and coordinates visits with their schedules. ( E) 3. Participates in clinical research to assist with routine tests, experiments, and related procedures and data management. ( E) 4. Maintain effective working relationships with study participants and other related research team members. ( E) 5. Confers with study PIs to assist in the developing plans for research projects, monitoring their implementation and coordination of resources for ongoing studies ( E) 6. Knows research protocols in detail and can train other study personnel on details. ( E) 7. Helps track study visits and procedures for each research study they are coordinating and assist with regulatory updates (e.g. IRB continuing review) and study budget monitoring.. ( E) 8. Maintain necessary supplies to implement clinical studies and order new supplies as needed. (E)
Regulatory Process Administration	10	1 Ensure compliance with protocol guidelines and requirements for regulatory agencies. ( E) 2 Assist with preparation of annual reports and handle other submissions and correspondence to IRB, award sponsors and other regulatory agencies, as needed. ( E) 3 Coordinate with internal departments/external entities and PI for regulatory and protocol compliance ( Sponsor Programs Administration, and Sponsored programs accounting, Sponsor, CRO, etc) ( E)

Zone Definition Factors

Contacts and Communications

TYPE OF CONTACT	LEVEL OF CONTACT	FREQUENCY OF CONTACT	PURPOSE OF CONTACT
Contact with PIs	All Levels of Contact	As needed	Facilitate grant and clinical trail submission data and document submission in a timely and correct manner. Complete technical requirements of research studies on a timey and correct manner.
Research Director	All Levels of Contact	As needed	Assist in the coordination of grant and clinical trial submission and progress in a timely and correct manner.
Research Staff	External to UNMC	As needed	Submission and management of data requested from research sponsors

Supervision Received

Dr. Murman & Deb Heimes will supervise this position.

Supervision Exercised

Does this position supervise?:

Type of Supervision Exercised:

N/A

Work Environment & Physical Demands

Working Environment

Office,Lab,Other/ Combined

If Other/Combined Environment, please explain:

clinical environment for technical component of position

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.

Adolescence (12-18 years),Adult (18-65 years),Geriatric (65 and older)

Activity Frequency

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

If other, please explain:

N/A

Lift, Carry, Push, Pull Activity

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

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

N/A

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:

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:

N/A

Use of Hands/ Wrists

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

If other use of hands/ wrists, please explain:

N/A

Sensory

Ability to Speak: YES	Depth Perception: YES
Hearing: NO	Distant Vision: YES
Sight: YES	Near Vision: YES
Color Vision: YES	Peripheral Vision: YES

NIMS/ICS

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

Campus Essential,Department Essential,If needed, could the employee work from home during an emergency condition?:Yes