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Aurora Health Care · 2 days ago

Research Coordinator

Milwaukee, WI

Full-time

Onsite

Entry, Mid Level

$30/hr - $45/hr

2+ years exp

Aurora Health Care is a healthcare organization seeking a Research Coordinator to manage clinical trials and research protocols. The role involves coordinating studies, mentoring team members, and ensuring compliance with research standards.

Health Care

Responsibilities

Performs clinical and administrative coordination of sponsored clinical trials, research protocols/projects, and biospecimen collection studies, as applicable. Provides guidance to physicians, clinical staff and research team members

Coordinates assigned research studies in collaboration with other team members and key stakeholders, including but not limited to; study start-up, review of study CTA/budget/CTMS, IRB submissions, recruitment, screening, and enrollment of research subjects, development of mechanisms to maximize subject adherence to the research protocol, maintain source documentation, data collection (i.e. development, completion and submission of case report forms (EDC), study drug/device accountability, monitoring of subjects, AE/SAE reporting, study close out, and facilitates quality assurance inspections and audits. Acts as a liaison between sponsor and investigators and as the primary protocol/project contact for team members and clinical staff

Plans, develops and implements educational plans to disseminate protocol/project information with research staff, investigators and clinical staff. Reviews protocol amendments and updates, research related orders (in collaboration with Investigational Drug Services), and study-specific workflows

Ensures that laboratory requirements are being met for specimen procurement, proper collection, processing and shipment of specimens

Serves as Primary Research Coordinator on studies across multiple sites guiding research team members involved in the study and coordinates and tracks research activities across sites

Coaches and mentors research team members and other personnel. Assist with implementation of educational training plans including orientation

Maintains competency in research computer applications Attends and participates in educational programs, meetings, and assigned committees

Licensed nurses will utilize advanced assessment skills to identify patient care problems, provide professional nursing care to research patients and support Research Coordinators in performing nursing activities as needed

Qualification

Clinical PracticesResearch study managementElectronic Medical Record (EMR)Microsoft Office SuiteMentoring team membersRapport buildingVerbal communicationWritten communicationOrganizational skillsTime managementProblem solvingAttention to detail

Required

Performs clinical and administrative coordination of sponsored clinical trials, research protocols/projects, and biospecimen collection studies, as applicable

Provides guidance to physicians, clinical staff and research team members

Acts as a liaison between sponsor and investigators and as the primary protocol/project contact for team members and clinical staff

Plans, develops and implements educational plans to disseminate protocol/project information with research staff, investigators and clinical staff

Reviews protocol amendments and updates, research related orders (in collaboration with Investigational Drug Services), and study-specific workflows

Ensures that laboratory requirements are being met for specimen procurement, proper collection, processing and shipment of specimens

Serves as Primary Research Coordinator on studies across multiple sites guiding research team members involved in the study and coordinates and tracks research activities across sites

Coaches and mentors research team members and other personnel

Assist with implementation of educational training plans including orientation

Maintains competency in research computer applications

Attends and participates in educational programs, meetings, and assigned committees

None Required

Bachelor's Degree in Biology, or

Bachelor's Degree in Health Science, or

Bachelor's Degree (or equivalent knowledge) in Nursing or related field

Typically requires 2 years of experience in Research

Knowledge of Good Clinical Practices, International Conference of Harmonization, FDA Guidance documents, Department of Health and Human Services regulations, standard operating procedures

Ability to successfully conduct and manage a research study

Ability to mentor team members and to prepare training plans

Excellent verbal and written communication skills, organizational and time management skills with ability to work under pressure and meet deadlines

Ability to problem solve and work independently with a high degree of accuracy and attention to detail

Must be able to establish a good rapport with patients, investigators and sponsors

Competency in using Electronic Medical Record (EMR), Microsoft Office Suite, and other computerized programs

Must be able to sit, stand, walk, lift, squat, bend, reach above shoulders and twist throughout shift

Must have functional sight and hearing

Ability to function in a latex environment

May be exposed to mechanical, electrical, chemical, and radiation hazards as well as blood and body fluids on a continuous basis; therefore, protective clothing (i.e., gown, mask, goggles, gloves, etc.) must be worn as necessary

Exposed to a normal office environment

Operates all equipment necessary to perform the job

Position may require travel among sites and therefore there is exposure to road and weather conditions