Clinical Research Nurse-RN - MOB Lindner Research HV - PRN

Facilitates the start-up of clinical projects in an acute
care/inpatient/outpatient setting. Assists in project initiation, which includes
educating physicians and hospital staff, implementing study protocol
assignments, facilitating patient enrollment and follow-up. Assures protocol
compliance, reports to the study Sponsor, and coordinates study participation
with the patient’s clinical health plan. The goal is to complete each clinical
trial with required enrollment, retention of subjects, and accurate data in
accordance with FDA guidelines. The RN will need to have a willingness to learn
innovative procedures such as the preparation and administration of stem cells,
the use of investigational devices and the administration of investigational
medications.

Responsibilities

1. Responsible for project management and implementation of study protocols.

* Assists in the initiation and maintenance of protocols. Strategically plans
the study flow and creates outlines and source documents.
* Responsible for the training of research staff members, physicians and
ancillary hospital healthcare professionals on study related procedures.
* Adjusts information aids, standing orders, study outlines when amendments to
the protocols occur.
* Consents patients, verifies inclusion/exclusion criteria, facilitates testing
and procedures, and coordinates patient visits to meet protocol requirements.
* Must be familiar with the policies and procedures of other hospital
departments, i. e., OR, Cath Lab, EP Lab, ICU, ED, Cancer Center and telemetry
units.
* Performs procedures and collects data in the ED, Cath Lab, EP Lab, ICU/step
down area, physician office, O. R., Cancer Center and other required areas
* Assists physicians and ancillary hospital staff with procedures and data
collection on sub-studies associated with project.
* Professionally represents the principal investigator and research center at
Investigator Meetings and training sessions.
* Accurately maintains Case Report Forms (CRFs) and source documentation.
* Submits serious adverse events (SAEs) to the IRB and sponsor per established
guidelines.
* Responsible for accountability during monitoring visits, sponsor audits, and
FDA audits.
* Fulfills on call duties related to study procedures.

2. Coordinates project management and patient activities to provide compliance.

* Serves as the contact for physicians, nurses and other ancillary hospital
staff to assure that all research and related clinical needs are achieved.
* Verifies that patients are scheduled appropriately for follow up evaluations
per protocol guidelines.
* Responsible for educating patients on the scientific objectives of the study
as well as to the importance of compliance with follow-up.
* Maintain control of drug/device inventory and validate storage at the
appropriate temperature.
* Guides the primary care physician in facilitating good protocol compliance
and clinical patient care through awareness of protocol objectives and
design.
* Makes recommendations on how to facilitate special or acute needs of
patients.
* Assists the screening team with patient consenting and performs reconsenting
as necessary.
* Fulfills IRB/FDA and protocol expectations.

3. Facilitates and maintains high patient enrollment and participation in
research protocols.

* Encourages new patient enrollment by identifying potential research patients,
discussing the protocols with physicians and communicating this information
to the screeners to facilitate the process.
* Works collaboratively with the physicians, hospital staff, patients, family,
and study sponsors to implement research procedures to promote optimal
outcomes.
* Alerts operational managers and physicians of possible patient withdrawal or
continuance issues immediately in order to implement a plan that will
encourage compliance with follow-up.
* Provides ongoing education to the patient and family members on the
risks/benefits of the study in an effort to develop rapport and encourage
compliance.

4. Participates directly in patient care duties associated with projects.

* Requires case management skills to assist the patient with financial aid in
order to obtain medication, medical care or transportation.
* Possesses a diverse knowledge base and is proficient in critical care nursing
skills and procedures.
* Continual assessment of patients to evaluate the outcomes of the use of the
investigational drug/device.
* Maintains accurate awareness of all clinical projects within the research
center.
* Utilizes critical thinking skills when executing protocol procedures to
maintain patient safety.
* Guides the physician in protocol compliance while making recommendations on
how to facilitate special or acute needs of the patient.

5. Performs other related duties as required or requested.

* Assures that the research center’s needs are recognized and cooperatively met
and action is taken as required to obtain desired outcomes.
* Assists non-RN staff with any clinical tasks or decision making duties.
* On-call responsibilities as required that includes approximately one weekend
every three months.
* Assists in training of new staff as needed.
* Demonstrates enthusiasm in the job.

Qualifications

Knowledge and Skills

Please describe any specialized knowledge or skills, which are REQUIRED to
perform the position duties. Do not personalize the job description,
credentials, or knowledge and skills based on the current associate. List any
special education required for this position.

EDUCATION: RN Diploma degree or Associates in Nursing required, BSN preferred,
BSN must be obtained within 5 years of date of hire.

YEARS OF EXPERIENCE: 3-5 years direct patient care experience required with 3
years clinical research and FDA/IRB regulations operations preferred.

REQUIRED SKILLS AND KNOWLEDGE: Photocopier, fax equipment, computer, all medical
equipment appropriate to research, and strong organizational skills. Excellent
communication skills, all essential patient care equipment and duty knowledge.

Licenses & Certifications

Licensed and Registered by the State of Ohio as a Registered Nurse.

Basic Life Support (BLS)