Additional Info

General Position Information

Position Number: 00089885	Working Title: Clinical Study 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. 2. Consult with Principal Investigator and other physicians 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; coordinate all diagnostic tests and procedures relevant to the study and follow-up to ensure the orders are carried out. 5. Responsible for placing all records including signed informed consent in patient chart and research record. Responsible for obtaining study lab samples, preparation, and coordination of specimen shipment. 6. 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, 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, 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) 10. Attend continuing education programs related to the clinical area. (E) 11. Attends Sponsor support study start up meetings. (E) 12. Act as back up to other coordinators within the Pediatric Research Office as necessary. (E) 13. Other duties as assigned.

Zone Definition Factors

Problem Solving - Decision Making

Responsible for independent problem solving and critical thinking as it pertains to successful implementation of pediatric clinical trials. Self-motivation to identify and address project needs is a critical component of this role.

Impact

This position has significant impact on UNMC and Children's Nebraska's pediatric clinical trial portfolio. This role serves our patients and our community by facilitating pediatric clinical trial availability.

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:

Responsible for tracking patient stipends, being familiar with study budget, understanding of study budget structure and the importance of tracking study activities for financial reimbursement to research office.

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
Research Subjects and Family Members	External to UNMC	Daily	Health Care, education and coordination of research treatment as directed by study protocol and study Principal Investigator
Pediatric Research Office Staff	Internal to UNMC	Daily	Coordination of study administrative requirements
Physicians, Nurses and Other Health Care Professionals	All Levels of Contact	Daily	Coordination and execution of clinical trial studies
UNMC Regulatory Affairs Office	Internal to UNMC	Weekly	IRB application completion and submission including submissions for any changes to approval, continuing review, reporting and study closeout.

Supervision Received

This position reports directly to CHRI's Senior Research Manager, but is day-to-day supervised by a Lead within the Pediatric Research Office. Supervision includes at-least weekly check-ins, training and onboarding, and assistance with initial assignments.

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: Continually (67-100%)	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: 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: 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: