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AND PATIENT CARE
The GCRC clinical staff is specially training in clinical research
due to the unique processes and procedures that are necessary in
conducting a protocol. The utmost commitment is made to patient
safety and the quality of nursing care. The nursing staff consists
of a nurse manager, Madelene Ottosen, RN; assistant nurse manager,
Glenna Scott, RN and six to eight full and part time nurses depending
on the schedule of protocols and patients. The GCRC clinic is open
usual business hours, but nursing assistance can also be provided
for protocols requiring after-hours or off-site patient care. The
nurse manager reviews all protocols prior to their implementation
to ensure that the nursing component is within the scope of the
GCRC in terms of patient care.
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The GCRC clinical unit is composed of four private
inpatient rooms and six outpatient rooms, as well as a patient waiting
area and nursing station. Patient care at the GCRC can be as minor
as taking vital signs and patient history to as complex as assisting
with invasive procedures and administration of chemotherapies. The
GCRC facilities are located within Memorial Hermann Hospital-Texas
Medical Center which provides medical coverage and emergency care
to the unit if necessary. All the nurses are BCLS certified and
many are ACLS certified. The GCRC nursing staff assists investigators
with room and patient preparation, equipment set up, inserting IV
lines and catheters, obtaining and processing blood and urine samples.
Instructions for processing, storing and shipping laboratory samples
for each protocol are developed and carried out by the clinical
staff of the GCRC.
All of the clinical staff receives training in patient safety,
Good Clinical Practices, patient privacy and confidentiality and
all records are HIPAA compliant. Patient care orders are carefully
reviewed by the nursing staff prior to subject enrollment. Nurses
and health care assistants working at the GCRC have expertise in
the meticulous data collection measures and sample collection and
storage processes required in clinical research. Investigators can
be assured their patients and protocols are given the utmost attention
by a highly qualified staff.
The nurse manager works closely with the Research Subject Advocate
to ensure the ethical and careful treatment of patients. A signed
Informed Consent form which has been approved by the Institutional
Review Board/Committee for Protection of Human Subjects must be
on file before a patient can be seen at the GCRC. The RSA meets
with the clinical staff on a weekly basis to discuss safety or ethical
issues.
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The GCRC nurses have been instrumental in developing
and actively involved in the expansion of the Association of Clinical
Research Nurses which encompasses all of the institutions within
the Texas Medical Center. This organization is dedicated to continuing
education and training of research nurses and increased awareness
and interest in clinical research.
Madelene Ottosen, RN, MSN 713-704-4147 Madelene.J.Ottosen@uth.tmc.edu
Glenna Scott, RN 713-704-4137 Glenna.Scott@uth.tmc.edu

Madelene Ottosen, RN, MSN, has been the nurse manager
for the GCRC for over 10 years. She works closely with investigators
and the Memorial Hermann Hospital Office of Research to ensure adherence
to protocol and patient safety. Each protocol is review by Ms. Ottosen
prior to submission to the Scientific Advisory Committee. Once approved,
she then works closely with the investigator and the nursing staff
to develop patient care orders including scheduling and billing
procedures. In addition to being involved with the Association of
Clinical Research Nurses, Ms. Ottosen also serves on the MHH Nursing
Clinical Practice Committee. Her responsibilities also include providing
training for nurses, students, fellows and faculty on various aspects
of clinical research, regulatory compliance and clinical practices.
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