Job Title Clinical Research Nurse
Category Clinical Research Coordinators
The MetroHealth System, Cuyahoga County’s public health system, and its staff of nearly 8,000 provides care at MetroHealth’s four hospitals, four emergency departments and more than 20 health centers and 40 additional sites throughout Cuyahoga County. The health system is home to Cuyahoga County’s most experienced Level I Adult Trauma Center, verified since 1992, and Ohio’s only adult and pediatric trauma and burn center. As an academic medical center, MetroHealth is committed to teaching and research. Each active staff physician holds a faculty appointment at Case Western Reserve University School of Medicine. Our main campus hospital houses a Cleveland Metropolitan School District high school of science and health. The MetroHealth System is committed to creating a healthier community.
Plans for, recruits, enrolls, documents and observes the progress of subjects enrolled in research studies. This is done in accordance with physician’s orders, study protocols, good clinical practice standards as well as approved/recognized standards of nursing care/nursing techniques, and procedures/administrative policies, as delegated by physician(s). Maintains the accurate and timely documentation of study visits, and notifies the Institutional Review Board (IRB) of deviations or violations from study protocol. Site visits occur in a variety of settings, such as inpatient, ambulatory, and the Clinical Research Unit (CRU). Notifies the IRB of adverse events in accordance with time frames established by the IRB. Works within the scope of nursing practice as defined by the State of Ohio. Follows MetroHealth System policies and procedures. Upholds the mission, vision, values, and customer service standards of The MetroHealth System.
Reviews charts, interviews patients, and/or converses with investigators to determine the eligibility of patients for clinical studies.
Recruits and screens subjects for eligibility as described in protocol.
Obtains informed consent prior to performing any study procedures; treats informed consent as an on-going process throughout the clinical trial.
Conducts study visits as specified in protocol; assures that all specifics of protocol are met, and notifies the IRB of deviations/violations from study procedures.
When necessary schedules subject visit(s) according to the schedule of evaluations in protocol; registers subjects for study visits in Epic (assuring that the appropriate research account is charged where required) for all visits on a Metro campus (i.e. clinic, labs, etc.).
Coordinates/schedules any required services from ancillary departments for the subject’s visit.
Takes patient histories; performs nursing exams as required, and triages subject needs.
Provides any necessary training/instruction to research staff and ancillary departments to ensure that required procedures are performed in accordance with protocol.
Maintains accurate and complete source documentation to meet FDA/sponsor/all applicable regulatory agency regulations and requirements.
Reports adverse events at the direction of the physician and protocol guidelines; notifies the IRB and the sponsor of adverse events in accordance with IRB and sponsor guidelines; immediately notifies the Risk Management office of any internal serious adverse events.
Accurately completes and submits Case Report Forms (CRFs) in the time requirements specified by the sponsor as applicable.
Maintains knowledge of all regulatory requirements for conducting research involving human subjects.
Provides overall patient management and protocol management.
Educates study subjects regarding the nature of illness/disease and of medication adherence/timing/dosage/ frequency/potential side effects, where applicable; as required prepares written educational material for participants while noting the IRB approvals required prior to distributing to participants; encourages subject compliance to study regimen.
Administers study medication when applicable as ordered by physician(s).
Informs the Primary Investigator (PI) of patients’ progress on study, and immediately informs the PI of adverse events experienced by participants.
Performs/schedules tests and procedures as specified in protocol, and within the scope of state licensure regulations.
Draws blood samples as required.
Assesses the condition of participants, reviews lab results immediately upon receipt, and immediately informs study physician of abnormalities.
Maintains and demonstrates current knowledge of specialty area(s).
When necessary performs and/or supervises testing procedures required by research study protocols.
Demonstrates clinical judgment/foresight in anticipating variances in research protocols.
Demonstrates clinical skills relating to the execution of research protocols.
Encourages subjects to exercise their rights as research participants.
- Following training, works in the Epic Electronic Health Record system to complete the following tasks:
a. Links patients to study specific research accounts and coverage (Epic Care).
b. Charts patient research visits (Epic Care).
c. Registers patients (Prelude).
d. Schedules/Checks in patients (Cadence 300-400).
e. Completes visit with charges to-be-billed (Resolute).
f. Scans consent forms (On-Base).
Participates in the identification of relevant new studies when required.
Coordinates and leads meetings with the investigator, referring physicians and patients to discuss protocols.
Maintains accurate and essential documents as required by the FDA, the IRB, the sponsor and/or funding agencies.
Attends monitoring visits with the sponsor monitor, and acts as liaison with the PI and the monitor/sponsor.
Prepares/assists with grant applications as required.
Assists with study budget preparation/review as required.
Prepares abstracts as required.
Develops positive working relationships with team members and ancillary departments to ensure smooth study progress.
Acts as a liaison between the investigator and the IRB as required.
Prepares advertising for the recruitment of subjects following prior IRB approval as required.
Keeps abreast of FDA, IRB and other regulatory agency compliance requirements and patient safety issues.
Maintains data integrity.
Manages study supplies where applicable.
Assists in preparing for FDA and internal audits as required.
Demonstrates creative, innovative and flexible approaches to problem solving in a research environment.
Assists with internal audits.
Performs other functionally related duties as assigned.
Bachelor’s degree of Science in Nursing (BSN) from an accredited school of nursing.
Current RN licensure in the State of Ohio.
One year of clinical experience as a staff nurse or 2 years of relevant, clinical research experience.
Current CREC (Continuing Research Education Credit) certification or obtains within 2 months of hire.
Good organization and problem-solving skills.
Excellent clinical skills.
Demonstrated proficiency with personal computers and various software/database applications.
Excellent interpersonal, written and verbal communication skills.
Ability to work independently
Current BLS certification.
May be required to obtain other certifications as determined by study protocols.
Note: Possesses and maintains competencies per department requirements as indicated on position posting.
Experience in research.
Institutional Review Board (IRB) experience.
Knowledgeable of Good Clinical Practice (GCP) in research.
For Specific Research Departments only:
Oncology Department: OCN certified, or obtains certification within 2 years of hire.
Emergency Department: One year of Emergency Department and/or ICU experience.
Emergency Department: ACLS Certification.
May sit, stand, stoop, bend, and ambulate intermittently during the day.
May need to sit or stand for extended periods.
See in the normal visual range with or without correction.
Hear in the normal audio range with or without correction.
Ability to lift 250-300 pounds with assistance.
Ability to push/pull up to 500 pounds with assistance.
Requires some exposure to communicable diseases or body fluids.
Requires some exposure to chemicals.