Under direction, to perfom work coordinating the monitoring of oncology clinical trials and researches projects involving cancer prevention and treatment. Ensures compliance with all regulatory standards.

PRINCIPAL DUTIES AND RESPONSIBILITIES(*Essential Functions)

1. Works collaboratively with the study Principal Investigator in the preparation of all required documents for submission to the Institutional Review Board (IRB) for the initial and ongoing review and reporting of research projects.


2. Prepares and maintains accurate and complete records for regulatory agency audits.


3. Ensures compliance with all regulatory and national standards, as well as with internal Institutional Review Board (IRB) regulations for all new and open approved studies.


4. Prepares appropriate consent forms to comply with federal, study sponsor, and IRB guidelines governing the use of human subjects in clinical trials.


5. Communicates closely with Principal Investigator in the evaluation of applicable research projects to meet the ongoing cancer program and patient needs.

JOB SPECIFICATIONS(Minimum Requirements)

KNOWLEDGE, SKILLS, AND ABILITIES

• Indiana State Licensure, if a Registered Nurse.
• Demonstrated oral and written communication skills and high attention to details.
• Ability to work independently and to function as a team member.
• Ability to provide a kind, compassionate and caring approach.

EDUCATION

• Bachelors degree from a recognized college or university in Nursing (BSN) is required, a Master's degree from a recognized college or university in Nursing (MSN) is preferred.
• Bachelors Nursing Required
• Masters Nursing Preferred
• Three (3) years of progressively responsible work experience in Hematology or oncology nursing, or a closely related field is required.
• Research work experience and knowledge of federal and local IRB guidelines governing the use of human subjects in research activities is preferred.
• 3 Healthcare/Medical - Oncology/Cancer Care Required
• Licensed Registered Nurse

STANDARDS OF BEHAVIOR
Meets the Standards of Behavior as outlined in Personnel Policy and Procedure #1, Employee Relations Code.

CONFIDENTIALITY/HIPAA/CORPORATE COMPLIANCE
Demonstrates knowledge of procedures for protecting and maintaining security, confidentiality and integrity of employee, patient, family, organizational and other medical information. Understands and supports the commitment of Methodist Hospitals in adhering to federal, state and local laws, rules and regulations governing ethical business practices for healthcare providers.

DISCLAIMER - The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. The statements are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.