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Research Nurse Oncology Research

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Company: Baylor Health Care System

Location: Dallas, TX

Date Posted: July 9, 2014

Source: Baylor Health Care System

Job Location: Dallas, TX

Baylor Health Care System (BHCS) has long been committed to the promotion of research on its campuses. In its endeavor to provide a cohesive and coordinated research effort at BHCS, Baylor Research Institute (BRI) seeks to identify and pursue unique research opportunities. The staff of BRI works with the staff of all BHCS entities to develop and promote medical research from the bench to the patient. Assisting staff in contract negotiations of clinical trials and identifying funding opportunities for research and inventions are part of the many services offered.

In addition to providing these services to the physicians and scientists involved in research at BHCS, BRI has set its goals to advance knowledge of disease and its treatment, promote research in our clinical programs, to have results of research promptly published in excellent medical and scientific journals, and accept only high-quality research. In the process of ...

Job Location: Dallas, TX

Baylor Health Care System (BHCS) has long been committed to the promotion of research on its campuses. In its endeavor to provide a cohesive and coordinated research effort at BHCS, Baylor Research Institute (BRI) seeks to identify and pursue unique research opportunities. The staff of BRI works with the staff of all BHCS entities to develop and promote medical research from the bench to the patient. Assisting staff in contract negotiations of clinical trials and identifying funding opportunities for research and inventions are part of the many services offered.

In addition to providing these services to the physicians and scientists involved in research at BHCS, BRI has set its goals to advance knowledge of disease and its treatment, promote research in our clinical programs, to have results of research promptly published in excellent medical and scientific journals, and accept only high-quality research. In the process of achieving these goals, the academic environment in Baylor Health Care System has been elevated.

We are currently seeking a Research Nurse. The Research Nurse assists various Principal Investigators, through delegated authority, with conducting clinical trials per federal, state and institutional guidelines. Responsibilities during all phases of trials including pre-study implementation through study closure are included in the scope of this position.

Job Functions

I. Per Federal law, the study’s Principal Investigator may delegate responsibilities related to conducting clinical trials. The types of responsibilities typically delegated to Research Nurses for Pre-study include:

1. Reviews new protocols and other materials provided by study sponsors and gives input to Principal Investigator and Manager, as applicable, regarding Nursing and Research issues in order to determine financial and clinical feasibility.

2. Coordinates implementation of various protocols for assigned Research projects with appropriate departments throughout Baylor Health Care System (BHCS) by interacting with Principal Investigators and Clinical Managers/Supervisors, providing in-service education for healthcare professionals and working with Pharmacy to ensure a smooth project flow.

3. Assists with preparation of Institutional Review Board (IRB) materials related to initial review and approval of the study.

4. Maintains communication with study sponsor and/or designee throughout study.

5. Assists in maintaining regulatory binders.

6. Helps ensures applicable study supplies, including study drug and/or devices, are received prior to study initiation.

7. Develops, field tests and critiques data collection forms and offers suggestions for revisions.

8. Develops appropriate protocol information sheets and pre-printed Physician Order sets for new investigational drug protocols and revises as indicated throughout the study period. Seeks multidisciplinary input in developing order sets.

II. Per Federal law, the study’s Principal Investigator may delegate responsibilities related to conducting clinical trials. The types of responsibilities typically delegated to Research Nurses during study include:

1. Screens patients for eligibility on assigned clinical trials in accordance with HIPAA standards.

2 Coordinates Research subject consent and entry into appropriate Research studies ensuring that all inclusion and exclusion criteria are met.

3. Manages Research subjects on assigned clinical trials, which may include the following: scheduling protocol required study visits, ensuring that all protocol required testing and treatments are done per protocol, assessing patients for adverse events, drawing pharmacokinetic and other research samples, and coordinating patient follow-up. Participates in daily clinic operations (Physician Offices and Inpatient Units where trials are being conducted) to include clinical assessment,education and delivery of patient care. May include administering investigational drugs.

4. Assumes technical responsibility for specific tasks, such as obtaining blood samples by phlebotomy, from arterial lines or central venous catheters in compliance with Baylor standards, centrifuging, specimen preparation, shipping and other related procedures.

5 Reports serious adverse events (SAEs) in a timely manner per study sponsor (or designee) and IRB requirements.

6. Assists with regulatory compliance including assisting with preparing IRB materials for approval of protocol amendments, submitting IND Safety Reports to the IRB, completing IRB continuing review reports and assisting with drug accountability.

7. Accurately completes case report forms in a timely manner.

8. Completes all applicable Research billing compliance procedures.

9. Coordinates study-monitoring visits.

10 Submits completed invoices for applicable patient care charges covered by funded Research studies to Baylor Research Institute (BRI) on a monthly basis.

III. Per Federal law, the study’s Principal Investigator may delegate responsibilities related to conducting clinical trials. The types of responsibilities typically delegated to Research Nurses for Post-study include:

1. Helps ensure that all study related activities are complete including returning supplies, returning unused stock of study drug/devices, and confirming that all queries are complete.

2. Assists with preparing Institutional Review Board final report.

3. Helps ensure that all study documents are complete and that records are retained per federal, state and institutional standards.

4 Participates in data analysis and writing and submitting manuscripts and abstracts for publication as appropriate.

IV. Per Federal law, the study’s Principal Investigator may delegate responsibilities related to conducting clinical trials. The types of miscellaneous responsibilities typically delegated to Research Nurses include:

1 Maintains current knowledge of departmental functions through reading literature, attending workshops, seminars and conferences, and by participating in professional organizations.

2 Utilizes Study Manager Clinical Trials Management System per departmental requirements.

3 Develops, implements and administers Research Nurse policies and procedures.

V. Per Federal law, the study’s Principal Investigator may delegate responsibilities related to conducting clinical trials. The types of miscellaneous responsibilities typically delegated to Research Nurses include:

1. Conducts audits of Research studies to check the accuracy, integrity and consistency of Research studies.

2. Cooperates with conduct of BRI quality audits.

3. Maintains patient and study confidentiality at all times.

4. Engages in positive working relationship with members of Clinical Trial Research Teams

Qualifications

License(s):
Registered Nurse

Education:
Associate's Degree-Nursing

Amount of Experience:
1 Year of Clinical Research Experience

Req ID:183246_1

Job ID: 183246_1

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