Clinical Research Coordinator I

Job Description

Job Description

Clinical Research Coordinator I

About NANI : NANI is the nation’s largest Nephrology practice. We have provided excellence in specialty kidney care for over 50 years. NANI’s nephrology practices are primarily operated in northern Illinois and throughout northern and central Indiana, with additional locations in New Jersey. NANI’s scope of care and services includes difficult-to-control hypertension, kidney disease, kidney injury, kidney transplant, and related services, as well as groundbreaking and lifesaving clinical research and consulting services

Join Our Team!

NANI’s research department is seeking a Clinical Research Coordinator I to join our team and be responsible for understanding and implementing multiple clinical research studies of a high level of difficulty under the direction of the Principal Investigator. This position will also oversee the work of the Research Assistant(s) assigned to the study and provide needed support to ensure the goals and objectives of the research project are met. Will work in Illinois at various research sites.

Travel required : This position will cover multiple locations, including Hinsdale, Evergreen Park, Chicago, Gurnee, and Huntley, Illinois. A willingness to travel among these cities is a must.

Summary : The Clinical Research Coordinator I is responsible for understanding and implementing clinical research studies under the direction of the Principal Investigator in accordance with good clinical practice. Oversees the work of the Research Assistant(s) assigned to the study.

Purpose : To ensure that the integrity of NANI Research is held to its highest and working to promote a safe and productive environment for the subjects involved in research studies throughout the NANI Organization.

Essential Duties and Responsibilities :

• Assist administration / investigators with study feasibility and selection of studies.
• Act as a liaison between the research staff and the sponsors, drug companies, IRB, federal, and state officials and other regulatory agencies.
• Schedule, prepare, and conduct monitor visits and sponsor / Federal Drug Administration audits.
• Attend investigator’s meetings and site initiation visits with the sponsor to review and assess progress and conduct the study.
• Coordinate protocol specific training for study staff and communicate important study updates such as study start-up and protocol amendments with all appropriate staff.
• Meet or exceed enrollment goals and modify recruitment strategies as necessary; recruit and screen patients for specific studies.
• Execute Informed Consent Forms according to ICH and GCP guidelines.
• Perform assessments at study visits according to protocol. Document study visits in source according to ALCOA-CCC.
• Collect, process, and ship laboratory samples according to protocol.
• Enter source document data into respective EDC vendor system and respond to queries in a timely manner.
• Perform vitals, ECG, and other study assessments required by protocol.
• Record adverse events and serious adverse events per sponsor guidance. Maintain timely follow-up to determine resolution of adverse event.
• Monitor investigational product temperature logs and report temperature excursions.
• Document protocol deviations and report to the IRB if applicable.
• Maintain regulatory documents from study start up to study completion.
• Perform other duties as assigned.

Education / Experience :

Qualifications

Work Environment : The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. Work may require occasional weekend and / or evening work

Physical Demands : The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of the position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.