Clinical Research Nurse Coordinator - Psychiatry (kumc)

Job Description

A Clinical Research Nurse Coordinator (CRNC) is responsible for managing and coordinating clinical trials within a healthcare setting. This role involves participation in recruitment and enrollment of patients, ensuring compliance with study protocols, and administering assessments, treatments or interventions as outlined in research protocols and/or delegated by the Principal Investigator. The coordinator is responsible for collaboratively working with multidisciplinary teams, research and hospital staff, sponsor representatives, and external stakeholders regarding various aspects of clinical trials. They also serve as a liaison between researchers, healthcare providers, and participants, while ensuring patient safety and data integrity. Additionally, a CRNC monitors adverse events, collects and manages clinical data, assist with regulatory submissions, and maintains detailed records in accordance with Good Clinical Practice (GCP) and institutional guidelines. Strong communication skills, attention to detail, and knowledge of clinical research procedures are essential for success in this role.

JOB IS FROM: nursingjobs.siteVIEWJob Duties:

Patient Recruitment and Enrollment:

• Identify and recruit eligible patients for clinical trials.
• Educate participants on the research protocol, potential risks, and benefits.
• Obtain informed consent from participants before enrolling them in studies.

Protocol Management:

• Implement and manage the clinical trial protocols.
• Ensure adherence to study protocols, regulatory guidelines, and ethical standards.
• Monitor the progress of the study, ensuring it stays on track with timelines and objectives.

Data Collection and Documentation:

• Collect, record, and maintain accurate clinical data.
• Ensure proper documentation of clinical observations, patient responses, and side effects.
• Manage electronic or paper case report forms (CRFs).

Patient Monitoring:

• Monitor participants during the study, ensuring their safety and addressing any adverse events or side effects.
• Administer medications or treatments as prescribed in the study protocol.
• Perform routine clinical assessments, scales, and tests as part of the trial.
• Identify and report adverse events (AE) or serious adverse events (SAE) to the Principal Investigator and sponsors as indicated in the protocol.

Collaboration with Research Teams:

• Work closely with principal investigators, physicians, pharmacists, and other members of the research team to ensure smooth trial execution.
• Act as the point of contact for research participants, answering their questions and concerns throughout the study.

Regulatory Compliance:

• Ensure the trial is conducted in compliance with local, state, and federal regulations (e.g., IRB approvals, GCP, FDA CFR).
• Maintain regulatory documents, ensuring that all records are up to date and accessible for auditing.
• Work closely with the Research Institute and Human Research Protection Program and have a working knowledge of KUMC policies and procedures.
• Work with study team to prepare documentation and participate in monitoring visits, SIVs, reviews, and audits.

Training and Support:

• Provide training to other staff members involved in the research project.
• Stay current with advances in clinical research and nursing practices to maintain knowledge of new treatments and protocols.
• Attend continuing education, research and training seminars as requested by manager.
• Assist clinical staff with phlebotomy and sample collection, processing, handling, and shipping as outlined in the protocol and in compliance with institutional/KUMC policy and IATAT.

Reporting:

• Assist in the preparation of study reports, manuscripts, and presentations.
• Provide progress reports on patient recruitment, data collection, and overall trial status to stakeholders.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice.

Required Qualifications:

Education:

• Bachelor of Science in Nursing (BSN) or equivalent nursing degree.

License/Certification:

• Valid state of Kansas RN License is required.

Work Experience:

• Experience with governing clinical research (CFR, GCP, HIPAA)
• Experience applying a basic understanding of statutes and guidelines relevant to regulatory affairs in clinical research
• 2 years of previous clinical research experience.
• Experience applying knowledge of clinical research methodologies, Good Clinical Practice (GCP), and regulatory requirements.
• Experience with medical terminology and clinical procedures.

Skills:

• Interpersonal skills.
• Attention to detail.
• Written, verbal, and presentation communication skills.
• Time management, multitasking, and organizational skills.

Required Documents:

• Resume/CV
• Cover Letter

Comprehensive Benefits Package:

Employee Type:

Regular

Time Type:

Part time

Rate Type:

Hourly

Compensation Statement:

The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above. 

Pay Range:

$31.42 - $48.70

Minimum

$31.42

Midpoint

$40.06

Maximum

$48.70