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

About the Role

Facilitates the start-up of clinical projects in an acute care, inpatient, or outpatient setting. Assists in project initiation, including educating physicians and hospital staff, implementing study protocol assignments, facilitating patient enrollment and follow-up. Ensures 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 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

• Responsible for project management and implementation of study protocols.
• Assists in the initiation and maintenance of protocols, strategically plans study flow, and creates outlines and source documents.
• Trains research staff members, physicians, and ancillary hospital healthcare professionals on study-related procedures.
• Adjusts information aids, standing orders, and 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.
• Familiar with the policies and procedures of other hospital departments (e.g., 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 the 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 and coordinates project management and patient activities to ensure compliance.
• Serves as the contact for physicians, nurses, and other ancillary hospital staff to assure all research and related clinical needs are met.
• Verifies that patients are scheduled appropriately for follow-up evaluations per protocol guidelines.
• Educates patients on the scientific objectives of the study and the importance of compliance with follow-up.
• Maintains control of drug/device inventory and validates 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 and maintains high patient enrollment and participation in research protocols.
• Encourages new patient enrollment by identifying potential research patients, discussing protocols with physicians, and communicating this information to screeners.
• Works collaboratively with physicians, hospital staff, patients, family, and study sponsors to implement research procedures and promote optimal outcomes.
• Alerts operational managers and physicians of possible patient withdrawal or continuance issues to implement a plan that encourages compliance.
• Provides ongoing education to patients and family members on the risks/benefits of the study to develop rapport and encourage compliance.
• Participates directly in patient care duties associated with projects, including case management to assist patients with financial aid for medication, medical care, or transportation.
• Possesses a diverse knowledge base and is proficient in critical care nursing skills and procedures.
• Continually assesses patients to evaluate the outcomes of the use of investigational drugs/devices.
• 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 facilitating special or acute needs of the patient.
• Performs other related duties as required or requested, including on-call responsibilities (approximately one weekend every three months).
• Assists in training new staff as needed.

Qualifications

• RN Diploma degree or Associate in Nursing required; BSN preferred (BSN must be obtained within 5 years of hire date).
• 3–5 years of direct patient care experience required; 3 years of clinical research and FDA/IRB regulations operations preferred.
• Proficiency with photocopier, fax equipment, computer, medical equipment appropriate to research, and strong organizational skills.
• Excellent communication skills and knowledge of essential patient care equipment and duties.

Licenses & Certifications

• Licensed and Registered by the State of Ohio as a Registered Nurse.
• Basic Life Support (BLS) certification.