Why work for Nebraska Methodist Health System?
At Nebraska Methodist Health System, we focus on providing exceptional care to the communities we serve and people we employ. We call it The Meaning of Care – a culture that has and will continue to set us apart. It’s helping families grow by making each delivery special, conveying a difficult diagnosis with a compassionate touch, going above and beyond for a patient’s needs, or giving a high five when a patient beats a disease or conquers a personal health challenge. We offer competitive pay, excellent benefits and a great work environment where all employees are valued! Most importantly, our employees are part of a team that makes a real difference in the communities we live and work in.

Job Summary:

Location: Methodist Physicians Clinic - Westroads Office Park III
Address: 1120 N. 103rd Plaza - Omaha, NE
Work Schedule: Monday through Friday, hours between 8am - 5pm

Coordinates clinical research studies of investigational medications, including but not limited to: regulatory compliance, study start-up phase, implementation of study, follow-up of research subjects, closeout of study, and study record maintenance. Conducts registry studies for data collection and observation (short and long term). Ensures proper billing services. Evaluates and ensures proper follow-up care is provided for all research subjects.

Responsibilities:

Essential Job Functions

1. Trial Management- Clinical or Device

• Verifies investigator/site feasibility, facilitates site budget/contract approval process, and develop timelines for conducting and completing the trial, as well as manage financial agreements.
• Attends Investigator Meetings as required.
• Prepare and submit initial study submission to IRB/IEC and/or sponsor for review and approval.
• Select the investigational staff and assign roles and responsibilities, ensuring appropriate training of staff.
• Maintain trial master file (e.g., regulatory binder), Identify minimum regulatory document requirements for site trial master file (e.g., country-specific regulatory documents), while ensuring IRB/IEC review/approval of study and study documents.
• Develop and follow a recruitment strategy and study management plan, maintain screening/enrollment log and ensure trial subject retention.
• Select and manage local vendors (e.g., laboratory, x-ray, MRI), and maintain current vendor credentials (e.g., lab certification/licensure and normal ranges) as applicable.
• Prepare study documentation (e.g., schedule of events, description of procedures) as well as modifying per protocol amendments require.
• Search clinical databases for potential participants, and schedule participants for protocol specific procedures, including multi-department visits as indicated in protocol.
• Conduct informed consent, working with the participant's the trial Investigator and/or Primary Care Physicians to ensure the participant understands study design.
• Collect, record, and report accurate and verifiable data, conducts participant visits according to requirements, documenting protocol deviations/violations and implementing corrective actions plans as applicable.
• Enter and transmit data, as well as review and resolve CRF queries from the study monitor/data management.
• Communicate laboratory/diagnostic results with Principal Investigator and Sponsor/CRO ensuring timely review of study data (e.g., laboratory results, x-rays).
• Manage study supplies (e.g., lab kits, case report forms), equipment (e.g., calibration and preventive maintenance), and study record retention and availability.
• Coordinate study monitoring visits, including site initiation, interim and close-outs.
• Prepare study documents and study summary and/or close-out letter for IRB/IEC.
• Interrogate implantable cardiac devices (i.e. pacemakers, defibrillators).
• Analyze implantable cardiac devices, perform diagnostic tests, and make appropriate device programing changes.

2. Trial Oversight

• Ensure adequate site management, while being compliant with electronic data requirements (e.g., electronic health records, eCRF).
• Ensure access to source data by authorized parties, in accordance with ICH-GCP, and protect confidentiality by limiting unauthorized access.
• Respond to or facilitate response to audit/inspection findings.
• Ensure proper adverse event reporting by the investigator.
• Escalate problems to appropriate in-house management.
• Investigate and/or report potential fraud and misconduct.
• Ensure follow-up medical care for study subjects is documented, as applicable.
• Ensure staff, facility, and equipment availability throughout the study.