Additional Info

1. Conduct recruitment activities for research studies (E)
2. Screen patients for inclusion into study protocols and ensure the treatment provided and the data collected adheres to study protocol. (E)
3. Coordinate research subject appointments, subject enrollment, and documents subject activity in the Electronic Medical Record (EMR) and Clinical Trial Master Matrix (CTMM). (E)
4. Assess health status by interviewing subjects regarding medical history, performing physical assessment and psychosocial assessment. (E)
5. Provide preliminary evaluation to determine final eligibility for enrollment into research protocol in consultation with physician at time of treatment decision. (E)
6. Gather and review subject medical information (e.g., medical record, radiology films, and pathology) from referring physician. (E)
7. Assess for insurance coverage and obtain insurance preapproval if required. (E)
8. Assist subject with travel arrangements, housing and orientation to Omaha and University of Nebraska Medical Center. (E)
9. Assist with obtaining informed consent by explaining investigative trials, all tests and procedures to subject/family and address any questions/concerns. (E)
10. Provide in-depth description of clinical trial including purpose, treatment plan, potential risks, potential benefits, financial obligations, and rights of research subjects. (E)
11. Complete all documentation requirements for research studies including electronic health record requirements. (E)
12. Evaluate progress of research trial with the Principal Investigator (PI) and report results of research to staff. (E)
13. Collaborate with research team members in related research coordination activities. (E)

1. Prepare physician orders; coordinate all diagnostic tests and procedures relevant to the study and follow-up to ensure the orders are carried out. (E)
2. Randomize or assist with randomization of subjects to treatment arms. (E)
3. Monitor subject health status during treatment and report adverse events and clinical events. (E)
4. Review test results with investigator and act upon as directed. (E)
5. Obtain study lab samples, prepare and ship specimens per protocol. (E)
6. Perform therapeutic procedures under the direction of the physician and the parameters of the research protocol. This may include but is not limited to infusions, injections, blood draws from central lines as required by the research protocols. ( E)
7. Complete required assessments, scales, and manage health abnormalities related to disease or treatment in collaboration with physician, other allied health personnel, subject and family throughout the research disease process/continuum (diagnosis, treatment, rehabilitation, palliative and terminal care). (E)
8. Provide psychological support to subjects and families. (E)
9. Complete all related research records and compile/ store appropriately.
10. Collaborate with the Principal Investigator and interdisciplinary team to institute modifications to practice for improvement of subject outcomes. (E)
11. Communicate and coordinate with physicians, clinical staff, coordinators, advanced practice professionals, and other related personnel to explain new investigational trials, update ongoing trials or address problems. (E)
12. Demonstrate knowledge and skill in addressing age specific needs of subjects, (all age groups-birth and above). (E)

1. Assist Principal Investigator by writing and submitting application, supporting materials and/or protocol for Medicare Coverage Analysis/billing compliance, to the IRB, Pharmacy and Therapeutics Committee, when new trials are initiated. (E)
2. Submit modifications to the protocol, IRB application, informed consents as needed during the course of the investigation. (E)
3. Prepare continuing reviews, requests for change, deviations/violations, internal and external adverse events and other reports to the IRB, FDA, and sponsoring agency as required. (E)
4. Coordinate and initiate research protocol with study sponsor, other health team members, and other UNMC departments affected by the research protocol and its requirements. (E)
5. Provide education to staff related to the protocol. (E)
6. Collect data including case report forms specific to study sponsor and/or institutionally required data. (E)
7. Accurately interpret and record data to ensure that research results are error free. (E)
8. Maintain regulatory documentation as appropriate to comply with governmental regulations and sponsor requirements.
9. Interpret, extract and record information from source documents and subject interview. (E)
10. Provide reports to investigator and sponsor (listing and statistical) as requested. (E)
11. Participate in monitor visits/site visits.
12. Collaborate with internal data management staff, statistical team and other research team members to assist, when applicable, in the collection, interpretation, and analysis of the data. (E)
13. Collaborate with PI in preparation of publications and study results to including conducting library literature searches, evaluation and analysis of data and reporting of statistical information utilizing computerized techniques. (D)
14. Assist in preparing estimated clinical research study budgets for subject care costs for the purpose of billing compliance, determining feasibility and final contract agreement. (D)
15. Manage all regulatory documents for participating sites communicating proactively with site investigators and coordinators. Manage drug accountability, gather and review external data, and report to drug manufacturer/sponsor and FDA as required. This may include Cooperative Group Trials and Regional Group Trials established by UNMC physicians. (E)

1. Attend continuing education programs related to the clinical research area. (D)
2. Review literature related to clinical research area. (D)
3. Communicate advances in nursing practice or research care to other health professionals through in-services, presentations and/or publications. (D)
4. Assure performance of behaviors that meet the requirements of the UNMC culture including: demonstrates behavior that fosters a positive team environment, demonstrates behaviors that promote diversity, applies continuous quality improvement principles, seeks the customers# requirements and strives to meet them, and designs personal action plan for personal and professional development. (E)
5. Flexibility to assume new duties as the Neurological Sciences program evolves. (E)
6. Other duties as assigned. (D)

As needed.

No

N/A

Office,Lab,Clinical,Other/ Combined

Clinical research lab

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

N/A

N/A

N/A

N/A

N/A

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