POSITION TITLE: CLINICAL STUDY COORDINATOR
TYPE: HOURLY/SALARY NON-EXEMPT
EMPLOYMENT STATUS: FULL-TIME
SALARY: COMMENSURATE WITH EXPERIENECE
DATE REQUESTED: JULY 7, 2026
AVAILABLE: IMMEDIATE
Position Purpose:
The Study Coordinator (SC) is a research professional who works alongside physicians, research nurses, study support staff, regulatory offices and staff, project sponsors, and Central Michigan University (CMU)/ University Pediatricians (UPeds) Clinical Research Center staff as it directly correlates to clinical trial studies. The SC will facilitate and coordinate clinical trial studies by performing these duties, in conjunction, with the principal investigator, institution, and funding organization. The SC will also submit regulatory (IRB) applications, hospital required compliance applications, and manage regulatory binders. In doing so, the study coordinator will provide support and guidance on the authority of compliance, financial, and other related aspects of the clinical study.
The Clinical Research Institute (CRI) is looking to fill the position of in-house Research Study Coordinator to support the ongoing clinical research across divisions within Children’s Hospital of Michigan. The candidate will work closely with research physicians and CRI staff to coordinate clinical research trials at the Children’s Hospital of Michigan. It is preferred that the candidate have research experience including patient consent and enrollment, clinical research study coordination, data and regulatory (IRB) management. The candidate will work with a multi-disciplinary team in a hospital setting and collaborate with other coordinators to achieve overall research study management. The candidate will also be expected to take primary coordinator responsibilities for clinical studies and investigator-initiated projects.
The expectations for this current position are as follows:
- Demonstrated proficiency managing work responsibilities by demonstrating confidence and ability to take the lead on a clinical trial or study; successfully submit regulatory documents with minimal guidance and demonstrated knowledge base for processing and shipping clinical samples.
- Demonstrated contributions to the CRI Infrastructure; including giving presentations, provide guidance for shipping study samples to other Coordinators; serving as a point of contact for regulatory questions/issues, performing QC checks on clinical data, and mentoring new Coordinators and part-time staff or students. The CRI and by extension, the research staff including investigational 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 investigational 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/investigational 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 required and some experience in a related field.
- Familiarity with regulatory (IRB) applications and addressing issues is helpful. Experience conducting clinical trials and following study protocols is desirable.
- Data entry and familiarity with databases such as REDCap, OnCore, etc.
- Ability to draft and/or amend protocol study documents.
- Experience with Qualtrics and MS Suite.
- Experience in human subjects/health services research.
- Experience working in a multi-disciplinary team; demonstrated ability to take the lead on a projects, work independently, and following up with stakeholders.
- Experience in obtaining and processing samples.
- Must be detail oriented with strong communication and customer service skills.
Additional Desired Qualifications
- Experience with scientific writing, including literature searches (e.g., PubMed, Google Scholar) and EndNote, and communicating scientifically about research findings
- Experience preparing and submitting regulatory documents for clinical research including interactions with the Institutional Review Board (IRB)
- Experience with FDA and IND studies
- Familiarity with Good Clinical Practice (GCP) Guidelines.
- Experience in a hospital/healthcare setting
- Well-versed in consenting study participants
- Understanding of HIPAA rules and regulations
- Flexibility to take call on evenings/nights/weekends during active study periods
Certificates, Licenses, Registrations: None
Expectations and Responsibilities:
1. Serve as the primary coordinator for multiple protocols of different PI’s in the Emergency Department. This includes managing the regulatory and operational aspects of the respective studies.
2. Consent and enroll patients in ED research studies as needed.
3. Create various research documents, including informed consent forms, assent, surveys/questionnaires, and patient-facing materials. Assist with the preparation and maintenance of study files.
4. Train research assistants, volunteers and study teams in participant recruitment techniques, data collection methodologies, ethical aspects of research, and the importance of maintaining research data securely.
5. Train pediatric emergency medicine fellows and residents in REDCap database construction, data abstraction for research projects, and data maintenance.
6. Review ED daily log and abstract data for ongoing QI and research projects
7. Prepare presentations for monthly division meetings to provide an overview of academic accomplishments and maintain records of ED academic activities, grants and research protocols.
8. Manage clinical trials.
a. Patient consent and enrollment, patient follow-up, data collection and reporting and sponsor monitor visits.
b. Prepare IRB documents for industry sponsored trials including new study submissions, continuations, amendments, unexpected events and closures. Maintain regulatory binders and tracking.
c. Participate in sponsor monitoring visits with CRI staff and Principal Investigators as needed.
d. Prepare source documents for clinical trials. Update files as needed.
e. Study maintenance and preparation of study enrollment reports as requested.
9. Perform miscellaneous job-related duties as assigned.
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. Flexibility to work non-traditional hours as needed, including on nights and weekends.
Pay: $50,000.00 - $55,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Professional development assistance
- Retirement plan
- Tuition reimbursement
- Vision insurance
Work Location: In person
