Additional Info

1. Oversee management of all aspects of research studies and function as the project manager for Sponsor-funded, Pharmaceutical, and IIT studies. 
2. Assist Principal Investigator by writing and submitting application and/or protocol to the IRB, SRC, Pharmacy and Therapeutics Committee. 
3. Submit modifications to the protocol, IRB application, informed consents as needed during the course of the investigation.  Prepare continuing reviews, internal and external adverse events and other reports to the IRB, SRC, FDA, and sponsoring agency as required. 
4.. Responsible for coordinating and initiating research protocols with study sponsor, investigational pharmacy, nursing staff, radiology, and other UNMC departments affected by the research protocol and its requirements. 
5.  Provide education and training to staff related to protocol.
6.  Responsible for data collection including case report forms specific to study sponsor and/or institutional required data.
7.  Accurately interpret and record to ensure that research results are error free.
8.  Coordinates sponsor visits from funding agencies, as well as prepare and obtain case materials for site visits.
9.  Coordinates the collection and testing of laboratory samples.  Process and store samples in the event that the lab personnel are absent.
10.  Maintain necessary supplies to implement research studies and order new supplies as needed.
11.  Ensure that tasks are being conducted in accordance with study-specific protocols, GCP, FDA regulations, and standard operating procedures,
12.  Knows research protocols in detail and can train other study personnel.
13.  Correspond with sponsors to develop contractual needs and negotiate study budget.
14.  Track patient study visits and procedures for each research study they are coordinating and ensure that study requirements are met.
15. Function as a point of contact for internal and external investigators looking to initiate new research studies.                                                                                                                                     16.  Function as a point of contact for internal and external investigators looking to initiate new research studies.                                                                                                                                      17.  Know research protocols in detail and can train other study personnel on details.                     18.  Ensure that tasks are being conducted in accordance with study-specific protocols, GCP, FDA regulations, and standard operating procedures.

1. Coordinates patient participation in investigational protocols; enrolls patient, processes consent form, educates patient regarding study, plans patient's evaluations, serves as patient's primary contact, evaluate and report trial progress to PI.
2. Perform therapeutic procedures under the direction of the physician.  Procedures may be dependent on research protocol.
3. Determine eligibility of patients by attending physician clinics.
4.   Gather and review patient information (e.g. medical records, radiology films, pathology) from medical records and referring physicians.
5. Obtain informed consent by explaining investigative non-therapeutic research and registry protocols, all tests, sample collections and procedures to patient/family and address questions or concerns.  Provide in-depth description of the non-therapeutic research and registry protocols including purpose, study plan, potential risks, potential benefits, and financial obligations, rights of the research subject.
6. Responsible for coordination of the non-therapeutic research and registry protocols while patient is participating in the protocol.  Assist in preparing physician orders; administer patient questionnaires, coordinate all diagnostic tests and procedures relevant to the study with physicians, schedulers, nurse case managers and follow-up to ensure orders are carried out.  Test results are reviewed with investigator and acted upon as directed.
7. Responsible for obtaining study lab samples, preparation, and shipment of specimens.
8. Provide support to patients and families.  Facilitate communication between patient/family and interdisciplinary team and assist in coordinating services related to patient care.

1. Provides data collection for sponsor studies by completing accurate case reports in a timely manner. 
2. Enters data into sponsor database(s) and uses databases to generate reports to PI. 
3. Maintain confidential patient files on each participant. 
4. Collect data from questionnaire, medical records and enter the data into the Informatics Databases (IDs)/Registries. Track Collection of required data, contact patients or centers for missing or ambiguous data. Maintain database quality by performing quality assurance check of entered data. 
5. Assist in the development and testing of data collection instruments (paper source and computerized) as needed. Interpret, extract and record information from source documents and potential patient interviews for support of clinical research. Provide reports to investigator and sponsor (listing and statistical) as requested. 
6. Collaborate with on campus data management and statistical team (Clinical Trials Office) to assist, when applicable, in the collection, interpretation, and analysis of the data. 
7. Collaborate with PI in preparation of publications and study results to include evaluation and analysis of data and reporting of statistical information utilizing computerized techniques and conducting chart reviews.

1.  Maintain and purchase study supplies, seek estimates, submit receipts when necessary.
2.  Provide information and resources to investigators regarding the use of database information and biospecimen.  Initiate collaboration between UNMC PIs and external investigators.
3.  Attend continuing education programs and review literature related to the clinical/research/registry area.  Communicates advances in research care to other health care professionals through in-services, presentations and/or publications.
4.  Assure performance of behaviors meet the requirements of the UNMC culture including demonstrates behaviors that fosters a positive team environment, demonstrates behaviors that promote diversity, applies continuous quality improvement principles, seeks the customer’s requirements and strives to meet them as well as designs personal action plan for professional development.
5.  Maintain phlebotomy training to complete study-related draws.
6.  Flexibility to assume new duties as oncology programs evloves
7.  All other duties as assigned.

Determined within a relatively short period of time

The value of this institution as a leading cancer clinic research institution is directly related to the proper collection and management of data and related databases

Results of studies reported by the investigators in the medical literature and at national and international medical meetings are dependent upon the collection and management of data collected.

Supervised by the PRMS and On-Core Oncology Manger

No

N/A

Office,Clinical

All Age Group

N/A

N/A

N/A

Mask in patient situations

Computer work

Entering Data information into system