Clinical Research RN - MOB Lindner Research HV - Full Time - Days

Responsibilities

• 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.
• Affirms 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.
• Responsible for project management and implementation of study 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.
• Aids 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.
• Seriously adverse events (SAEs) are submitted 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.
• Covers 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.
• 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.
• 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.
• 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.
• Aids non-RN staff with any clinical tasks or decision making duties.
• On-call responsibilities as required that includes approximately one weekend every three months.
• Aids in training of new staff as needed.
• Demonstrates enthusiasm in the job.

Qualifications

• KNOWLEDGE AND SKILLS:
  • Specialized knowledge or skills, which are REQUIRED to perform the position duties.
  • 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).