Clinical Research Coordinator - Internal Medicine (Pulmonary)

University of Kansas Medical Center•Kansas City, KS

2d•Onsite

About The Position

The Clinical Research Coordinator (CRC) in the Division of Pulmonary, Critical Care, and Sleep Medicine is responsible for coordinating and managing clinical research studies in accordance with regulatory requirements and institutional policies. This role involves the planning, implementation, and oversight of research protocols, ensuring compliance with FDA regulations, GCP guidelines, IRB approvals, and HIPAA requirements. The CRC will collaborate with investigators, sponsors, and participants to facilitate all aspects of study conduct, including subject recruitment, informed consent, data collection, and reporting.

Requirements

4 years of experience in health sciences, nursing, biology, or related field. Education may be substituted for experience on a year for year basis.
2 years of clinical research experience.
Experience with clinical research regulations (FDA, GCP, IRB, HIPAA).
Organization.
Problem-solving.
Communication.
Computer skills.

Nice To Haves

Phlebotomy certification.
4 years of clinical research experience.
Experience in pulmonary, critical care, or sleep medicine research.
Experience with REDCap, Epic, or similar data management systems.

Responsibilities

Study Coordination & Management: Coordinate multiple clinical research studies, including investigator-initiated and industry-sponsored trials.
Develop and maintain study-specific documents, including regulatory binders, case report forms, and data collection tools.
Ensure research protocols are conducted in accordance with IRB, FDA, NIH, and institutional regulations.
Monitor study progress, ensuring adherence to timelines and compliance with protocols.
Patient Recruitment & Enrollment: Identify and screen eligible participants for clinical studies based on protocol inclusion/exclusion criteria.
Obtain informed consent and educate participants about study procedures, risks, and benefits.
Schedule study visits, follow-ups, and coordinate necessary clinical assessments.
Data Collection & Regulatory Compliance: Collect and enter accurate research data into electronic data capture (EDC) systems.
Maintain compliance with Good Clinical Practice (GCP) and institutional policies.
Prepare and submit regulatory documents to IRB and sponsor organizations.
Assist in audits, monitoring visits, and responses to queries from regulatory agencies.
Clinical & Laboratory Responsibilities: Coordinate sample collection, processing, and shipping according to study requirements.
Assist with study-related procedures such as pulmonary function tests, sleep studies, and vital sign monitoring under supervision.
Ensure investigational products (drugs, devices) are handled per protocol and regulatory requirements.
Collaboration & Communication: Act as a liaison between study sponsors, investigators, patients, and healthcare providers.
Participate in research team meetings, sponsor calls, and professional development sessions.
Provide education and training to new research personnel and clinical staff as needed.

Benefits

Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan.
Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available.
Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays.
One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment.
A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available.

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