Overview
Position Title: Clinical Study Nurse
Type: Salary Non-exempt
Employment Status: Full-timeSalary:
COMMENSURATE WITH EXPERIENECE
Date Requested: January 5, 2026
Available: IMMEDIATE
Supervisory Responsibilities: None
Position Purpose:
The Clinical Study Nurse (CSN) will function as Clinical Study Coordinator to coordinate participant visits, coordinate and monitor clinical studies, manage the administrative and regulatory aspects of the protocols and to review and present study protocols. In addition, the clinical study nurse will assist the Clinical Research Institute and University Pediatricians Leadership to manage the research clinical space and to perform nursing-related activities such as blood draws, medication infusions, vital assessments, research ECGs, among other activities.
Some of the specific expectations for this current position are as follows:
· Demonstrated proficiency managing work responsibilities by successfully acting as lead Coordinator on clinical trials and studies; independently submitting regulatory documents to the university and hospital and maintaining common use sample processing equipment.
· Demonstrated contributions to the CRI Infrastructure by ensuring all equipment with the Clinical Research Center is in working condition; order supplies as needed; perform blood draws and other medical tests as needed for studies within the CRI and other Divisions. Serve as backup to Research Nurses in other Divisions. The CRI and by extension, the research staff including clinical study nurses, clinical study coordinators and clinical study assistants, share a responsibility to the customers that are served by University Pediatricians. These customers include the investigators, the research sponsors and the patients and families who participate in our research protocols.
· Assuring that for the investigators/divisions that you serve, you or a member of your team (if you work with a research coordinator group) are added to every research protocol that is submitted to the CMU IRB and DMC CRO. Regardless of the type of application and the scope of work for an clinical study nurse/ coordinator, the expectation is that a research coordinator will be able to monitor and guide the application process and will be available to answer questions and respond to emails that may come to the investigator as part of the protocol review.
· In coordination with your division, PI and research team, the research staff/clinical study nurse will track timelines and deadline and move critical documents and approvals forward to the CRI leadership in a timely manner.
Qualifications:
· Bachelor’s degree in nursing and registered nurse licensure to practice in the state of Michigan.
· Minimum of one (1) year work-related experience in both nursing and in the management of clinical trial research protocols with a focus on regulatory compliance, management of study visits and consenting participants.
· Some experience with IRB protocol applications and amendments.
· Experience with date entry and project databases such as industry sponsor electronic data capture (EDC) systems and REDCap is essential.
· Strong understanding of HIPAA regulations and the guidelines related to protected health information (PHI).
· Detail oriented and strong organizational skills required.
· Strong interpersonal skills and communication strengths, demonstrating a knowledgeable grasp of medical and research-related terminology.
· Exceptional leadership with a focus on organization, timelines and clear communication with other research support staff.
· Experience working in a multi-disciplinary team; demonstrated ability to take the lead on a projects, work independently, and following up with stakeholders.
· Familiarity with Good Clinical Practice (GCP) and HIPAA rules and regulations.
· Write clearly and informatively; able to read and interpret written information. Balance team and individual responsibilities; Exhibits objectivity and openness to others' views; contributes to building a positive team spirit.
Additional Desired Qualifications
· Some experience working in a pediatric patient setting.
· Experience with scientific writing, including literature searches (e.g., PubMed, Google Scholar) and EndNote, and communicating scientifically about research findings
Certificates, Licenses, Registrations: State of Michigan Registered Nurse required; CITI certified required but can obtain after hire
Expectations and Responsibilities:
1. Safely and effectively administer study medications and accurately document the administration in source documents.
2. Collect and record subject study data into source documents or electronic data systems ( i.e, vital signs, adverse events, concomitant medications, etc.).
3. Responsibilities include but not limited to, sample collection, I.V. and phlebotomy, medication administration, EKG’s, monitor vital signs, and other procedures required by protocols.
4. Conduct participant recruitment, implementation of study procedures as outlined in the protocol, sample collection, source document creation, and documentation of data.
5. Network with different investigators to coordinate a participant visit.
6. Collaborate closely with study investigator and Clinical Research Manager informing on relevant adverse events and serious adverse events according to procedures outlined in the protocol.
7. Process patient lab specimens and ship/store them per protocol, ensure the diagnostic specimens are packaged and shipped per IATA guidelines.
8. Assist in coordinating site visits for prospective research and pharmaceutical companies.
9. Provide support for all aspects of research conducted by the research center.
10. Assist in other study specific research as required.
Competencies
Customer Service - Respond promptly to customer needs; Responds to requests for service and assistance.
Interpersonal Skills - Maintain confidentiality; Listen to others without interrupting; Keep emotions under control; Remain open to others' ideas and tries new things.
Oral Communication - Speak clearly and persuasively in positive or negative situations; Participates in meetings.
Written Communication - Write clearly and informatively; Able to read and interpret written information.
Teamwork - Contribute to building a positive team spirit.
Ethics - Treat people with respect; Uphold organizational values.
Organizational Support - Follow policies and procedures, complete administrative tasks correctly and on time, support organization's goals and values.
Planning/Organizing - Organize or schedule other people and their tasks.
Quantity - Meet productivity standards.
Attendance/Punctuality - Is consistently at work and on time; ensure work responsibilities are covered when absent; arrive at meetings and appointments on time.
Working Conditions:
1. Regularly lift up to 25-50 pounds with or without assistance.
2. Able to complete duties under stress, deadlines, and while attending to multiple duties simultaneously.
3. Prolonged computer related exposure, as well as sitting and standing at workstations for long periods of time.
4. Noise level in the work environment is usually moderate.
5. Bending, sitting, walking, and standing frequently throughout the day.
6. Occasionally work non-traditional hours as needed.
This position is exempt from overtime pay provisions of the Federal Fair Labor Standards Act.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
I understand the responsibilities, duties, and working conditions of this job description and is not intended to be all inclusive or limiting as to specific duties, and can change at the employer’s discretion without notice.
Job Types: Full-time, Permanent
Pay: From $60,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible schedule
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Tuition reimbursement
- Vision insurance
Work Location: In person
