Clinical Research Coordinator RN/LPN

Family Allergy & Asthma; Louisville (KY); On-site; USD 55,000 - 70,000; Full time

Job summary

A leading healthcare organization in Louisville is seeking a Clinical Research Coordinator RN/LPN to ensure the safety of study subjects and manage clinical trials. The role involves coordinating study protocols, maintaining documentation, and adhering to ethical standards. Candidates should be licensed RNs or LPNs with medical practice experience. Join a dedicated team committed to excellence in patient care and research.

Qualifications

• Licensed RN/LPN or minimum 2 years’ medical practice/office experience.
• Research experience preferred.

Responsibilities

• Ensure the safety and well-being of all study subjects throughout the trial.
• Manage study conduct throughout the trial including screening and recruiting subjects.
• Handle adverse event reporting and ensure proper documentation.

Skills

Medical Terminology

Computer Skills

Education

RN/LPN License

ACRP Certification

Job description

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Description

Job Title: Clinical Research Coordinator - RN/LPN

Division/Department: Research

Reporting Relationship: Director of Clinical Research

Location of Job: Germantown office – 1261 Goss Avenue, Louisville, KY 40217

Work Schedule: M-F 8-5

Objectives

• Ensure the safety and well-being of all study subjects throughout the trial.
• Support and adhere to Good Clinical Practices (GCP’s), Federal Regulations and ethical standards as set forth in Family Allergy and Asthma SOP manual, the Federal Code of Regulations and as provided by Sponsors where appropriate.
• Execute assigned coordination duties in a timely, accurate and efficient manner.
• Ensure the proper and timely maintenance of study related documents, including study files, patient charts, and supporting documentation.
• Promote personal and professional relationships by incorporating Family Allergy and Asthma core values of: Care, Advocacy, Service, Integrity, Accountability, and Fun in daily performance.

Duties And Responsibilities

• Assume primary responsibility for protocol initiation; from start to finish; to include, but not limited to:
• Assist in evaluating new protocols for feasibility at the site: reviewing the protocol, Investigator Brochure and Informed Consent Form.
• Assess subject eligibility requirements to determine if the population exists and would be available in the practice.
• Assess the ability to meet study timelines in light of other site commitments and overall feasibility.
• Assess the resources necessary to perform the study, including people, physical space, and materials.
• Prepare the site for conducting the study, including setting up and organizing study files, confirming QA measures, ensuring delegation of authority log signatures, reviewing or creating source documents, developing recruitment plans, and submitting IRB documents.
• Participate in investigator meetings and actively seek assistance from the sponsor when needed.
• Assist with informed consent process, including presenting the document, discussing the study, answering questions, and obtaining signatures.
• Manage study conduct throughout the trial: ensuring IRB approval, screening and recruiting subjects, adhering to protocol, scheduling visits, maintaining materials and supplies, promoting retention, and assisting during subject visits.
• Handle adverse event reporting, including serious adverse events, and ensure proper documentation and communication with Sponsor, IRB, and PI.
• Dispense study medication/device, maintain accountability, and manage study data entry and query resolution.
• Work with sponsor monitors, prepare for monitoring visits, and ensure study documents are complete and organized.
• Manage laboratory procedures, reorder supplies, and document compensation to subjects.
• Coordinate technical study aspects (e.g., PFT, skin testing, ECGs) and maintain equipment.
• Perform study closeout activities and other duties as assigned.
• Recruit for other protocols, assist colleagues, and ensure documentation is organized for storage.
• Report monitoring visits, audits, and participate in staff meetings and training.
• Work towards National Certification (ACRP) and maintain HIPAA compliance.

Requirements

• Licensed RN/LPN or minimum 2 years’ medical practice/office experience; research experience preferred.
• Extensive knowledge of medical terminology.
• Previous computer experience.
• CPR certification; ACRP certification preferred.

Equipment/Machinery Used

Computer, Pulmonary Function testing, ECG, Centrifuge, Fax, Copier, Digital Stadiometer, Peak Flow Meter, Manometer, Digital Thermometer, Nebulizer.

EEOC Compliance

Family Allergy & Asthma provides equal employment opportunities and prohibits discrimination and harassment of any type.

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