CLINICAL RESEARCH NURSE-RN

Job Description

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.

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

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

5. Performs other related duties as required or requested.

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)