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.

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.

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.

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.