Clinical Study Coordinator - CRI

Clinical Study Coordinator

• CRI University Pediatricians
• 2.9 Detroit, MI Job Details Full-time $48,000
• $52,000 a year 14 days ago Benefits Health savings account Health insurance Dental insurance 401(k) Flexible spending account Tuition reimbursement Paid time off Employee assistance program Vision insurance 401(k) matching Life insurance Qualifications Project team coordination Web-based survey tools Clinical research Customer service Team leadership Scientific research HIPAA Administrative experience Bachelor's degree Clinical data entry Scientific protocols Leading team collaboration initiatives Implementing research protocols Managing projects Research and development project management Quality data entry Full Job Description

POSITION ANNOUNCEMENT

Position Title:

Clinical Study Coordinator Type:

Hourly/Salary Non-exempt Employment Status:

Full-time Salary:

COMMENSURATE WITH EXPERIENECE

Date Requested:

May 15, 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 CMU/UP Clinical Research Institute (CRI) is looking to fill the position of Research Study Coordinator. 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.

Qualifications:

Bachelor's Degree required and one (1) year minimum experience in a related field. Familiarity with regulatory (IRB) applications and addressing issues. Three years experience conducting clinical trials and following study protocols. 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. Knowledge and experience with clinical trial management systems Understanding of GCP and HIPAA rules and regulations. Exceptional leadership, organizational and communication skills. Additional Desired Qualifications 1. Masters-level/ advanced degree with five (5) years experience managing clinical trials. 2. Relevant experience in an academic health center, medical school or higher education. 3. Certification as a Clinical Research Coordinator. 4. Clinical Trial Management System experience. 5. Experience with scientific writing literature searches (e.g., PubMed, Google Scholar) and EndNote, and communicating scientifically about research findings.

Certificates, Licenses, Registrations:

None Expectations and Responsibilities:

1. Serve as the primary coordinator for multiple protocols across disciplines. This includes managing the regulatory and operational aspects of the respective studies. 2. Assist the CMU-UP Clinical Research Institute in the start-up and development of a clinical trial management system

• CTA (Oncore). This position will assist the CRI Executive Director and CRI pre
• and post
• award staff in the creation of the fields and processes related to the key tracking elements associated with research at CMU.

3. Assist with the preparation and maintenance of study files 4. Assist the Associate Director and Executive Director with internal audits of study binders, study files, and databases. 5. Responsible for the pulling of reports and auditing data entered the clinical trial management system. 6. Management of clinical trials for FDA investigational devices and drugs. a. Patient consent and enrollment, patient follow-up, data collection and reporting and sponsor monitor visits. b. Preparation of IRB documents for industry sponsored trials including new study submissions, continuations, amendments, unexpected events and closures. Maintaining regulatory binders and tracking. c. Assist investigators with FDA submissions and IRB requirements of Compassionate Treatments. d. Participation in site initiation and sponsor monitoring visits with CRI staff and Principal Investigators as needed. e. Preparation of source documents for clinical trials. Update files as needed. f. Study maintenance and preparation of study enrollment reports as requested. 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. Frequently work non-traditional hours as needed. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Job Type:

Full-time Pay:

$48,000.00

• $52,000.

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 Tuition reimbursement Vision insurance Ability to

Commute:

Detroit, MI 48201 (Required) Ability to

Relocate:

Detroit, MI 48201: Relocate before starting work (Required)

Work Location:

In person