Research Study Coord RN

Responsibilities
1. Enrolls patients in research studies; obtains informed consent from patients or legal representatives; performs screening procedures and is responsible for primary care of study patients; ensures compliance with FDA and sponsor regulations. a. Assesses patients condition, readiness and eligibility for study enrollment as a research subject based on assessment skills and tools and criteria outlined in study protocols. b. Develops a plan of care for the patients study participation with the patient, family, principle investigator, patient’s primary physician(s) and study team based on assessment integrated with the study protocol and medical plan of care. c. Implements patient care, collaborating with applicable individuals to complete data collection for each study patient. May be assigned as the patient’s primary contact with the responsibility of total patient care, or may be utilized as a resource on the applicable unit. d. Coordinates and delegates the delivery of care by selected members of the health care team as prescribed in the study protocol under the direction of the principle investigator. e. Maintains clinical competence by assuming responsibility for acquiring knowledge and experiences, and integrates, as appropriate into patient care delivery based upon specific patient needs. Gains certification in CPR and/or appropriate specialty fields as required by type of study. f. Documents delivery of health care and processes in accordance with specific unit standards and hospital policy.
2. Monitors progress of research patients; documents responses to investigative agents or devices; communicates with study investigators about patient’s progress, designs patient flow charts and documentation.
3. Evaluates the need for patient education, instruction and training pertaining to research studies; determines the need for termination of patient participation on collaboration with the study investigator.
4. Coordinates accurate inpatient account services and ensures accurate billing.
5. Provides education programs as required.
6. Participates in study site visits and ensures the safekeeping and accurate inventory of investigational drug supplies.
7. Assumes responsibility for coordinating, completing and maintaining data collection for case report forms.
8. Participates in the planning and operation of research activities.
9. Educates staff and physicians concerning rules and regulations; maintains current information regarding regulations.
10. Maintains an impartial, objective and professional attitude at all times.

Minimum Qualifications
Current license to practice nursing (RN) in the state of Texas is required. Two (2) years general nursing experience is required. Some administrative experience is required.

Preferred Qualifications
This position will be part of growing adult oncology research program that is part of the National Cancer Institute’s National Community Cancer Center Program pilot. This position will allow the initiation of chemo and biological therapy cancer treatment research and the RN coordinator can work with physicians, other coordinators and Seton Office of Research Administration to develop this aspect of clinical research.

Oncology research experience and chemo and/or OCN certification preferred. Commitment to working with diverse patient population. Bilingual English/Spanish preferred. Interest in participating in leading-edge research and rapidly growing oncology research program

Skills
Must be able to effectively communicate, both verbally and in writing with physicians and other health care professionals. Must be able to maintain the confidentiality of research subjects and research protocols.

Physical Demands
Medium (requires lifting 50 lbs, with frequent carrying of up to 25 lbs)
Balancing:............Frequently
Bending:...............Rarely
Carrying:...............Frequently
Climbing:.............Occasionally
Crawling:..............Rarely
Crouching:............Frequently
Fine Dexterity:.......Frequently
Foot Controls:.......Frequently
Handing:..............Frequently
Hearing:...............Continuously
Kneeling:.............Frequently
Lifting:..................Frequently
Pushing Pulling: .Frequently
Reaching:............Frequently
Sitting:...................Frequently
Standing:..............Frequently
Talking:................Continuously
Twisting:..............Occasionally
Vision:..................Continuously
Walking:...............Frequently

Work Environment
Involves no exposure to blood borne pathogens as part of duties

Supervision Received
Director

Supervision Exercised
N/A
Physical Other
NONE

Other Functions
1. Performs other duties as assigned.

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