Clinical Research Coordinator
M.I.N.D
2 days ago
Full-time
On-site
Farmington Hills, Michigan, United States
$20 - $23 USD hourly
Occupational Therapist
Classification FSLA – Non-Exempt/Hourly
Salary Grade/Level/Range
Level of experience, longevity, certification, within company pay structure
Reports to: Clinical Infusion and Research Manager
Summary/Objective
The Clinical Research Study Coordinator is responsible for the day-to-day coordination and management of clinical research studies conducted within the neurology infusion center. This role ensures protocol adherence, accurate data collection, regulatory compliance, and effective communication between investigators, sponsors, CROs, clinical staff, and patients.
The Study Coordinator supports study start-up, participant screening and enrollment, visit coordination, data management, and regulatory documentation to ensure high-quality research execution and patient safety.
Work Environment
This position operates in a medical infusion and research center and routinely uses computers, EMR systems, electronic data capture (EDC) platforms, phones, and standard office equipment. Interaction with patients, clinical staff, providers, and external research partners is routine.
Essential Functions
Study Coordination & Execution
Coordinate assigned clinical research studies from start-up through close-out
Screen, recruit, and enroll eligible research participants according to protocol criteria
Schedule and coordinate study visits, procedures, infusions, labs, and follow-ups
Ensure protocol-specific procedures are completed accurately and within required timelines
Study Start-Up & Regulatory Support
Assist with study start-up activities, including feasibility assessments, site readiness tasks, and workflow development
Prepare and maintain regulatory documents including investigator site files (ISFs), delegation logs, training logs, and essential documents
Support IRB submissions, amendments, renewals, and continuing reviews as directed
Ensure staff training documentation is current and protocol-specific training is completed
Data Management & Documentation
Accurately collect, enter, and maintain study data in EDC systems and source documents
Ensure data accuracy, completeness, and timeliness in compliance with GCP and protocol requirements
Respond to data queries and collaborate with monitors and sponsors during monitoring visits
Maintain organized and audit-ready study documentation
Clinical & Operational Collaboration
Collaborate closely with infusion nurses, providers, and research leadership to coordinate study-related care
Communicate effectively with sponsors, CROs, and monitors regarding study progress and issues
Assist with investigational product accountability, documentation, and coordination with pharmacy or nursing staff as applicable
Patient Education & Support
Educate study participants on protocol requirements, visit expectations, and study procedures
Serve as a primary point of contact for research participants throughout study participation
Ensure participant safety, confidentiality, and informed consent compliance at all times
Compliance & Quality
Ensure compliance with study protocols, GCP guidelines, HIPAA regulations, and institutional policies
Maintain confidentiality of patient and study information
Assist with monitoring visits, audits, and inspections as required
Identify protocol deviations and escalate concerns to research leadership
Daily / Ongoing Responsibilities
Track study milestones including enrollment, visits, and follow-ups
Maintain study calendars and visit schedules
Assist with ordering and tracking study supplies and materials
Perform assigned clerical duties including filing, scanning, copying, and data organization
Support infusion and clinical teams with research-related coordination needs
Physical Demands
Work involves sitting, standing, and walking throughout the day. Visual acuity, auditory acuity, and manual dexterity are required for data entry and documentation. Minimal lifting may be required.
Position Type/Expected Hours of Work
Full-time position. Typical hours are Monday through Friday. Evening hours may be required based on study or operational needs.
OSHA Exposure Classification:
Job Category I. Direct contact with blood or other body fluids (Bloodborne Pathogens) to which Universal Precautions apply. Personal protective equipment is made available and must be worn.
Travel
Travel may be required to satellite infusion or research locations or for sponsor meetings and training.
Required Education and Experience
Associate’s or Bachelor’s degree in a health-related or science field preferred
Prior experience in clinical research coordination preferred
Knowledge of GCP, IRB processes, and clinical research regulations preferred
Experience with EMR and EDC systems preferred
Strong organizational, communication, and documentation skills
Other Duties
Please note 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. Duties, responsibilities and activities may change at any time with or without notice.
Salary Grade/Level/Range
Level of experience, longevity, certification, within company pay structure
Reports to: Clinical Infusion and Research Manager
Summary/Objective
The Clinical Research Study Coordinator is responsible for the day-to-day coordination and management of clinical research studies conducted within the neurology infusion center. This role ensures protocol adherence, accurate data collection, regulatory compliance, and effective communication between investigators, sponsors, CROs, clinical staff, and patients.
The Study Coordinator supports study start-up, participant screening and enrollment, visit coordination, data management, and regulatory documentation to ensure high-quality research execution and patient safety.
Work Environment
This position operates in a medical infusion and research center and routinely uses computers, EMR systems, electronic data capture (EDC) platforms, phones, and standard office equipment. Interaction with patients, clinical staff, providers, and external research partners is routine.
Essential Functions
Study Coordination & Execution
Coordinate assigned clinical research studies from start-up through close-out
Screen, recruit, and enroll eligible research participants according to protocol criteria
Schedule and coordinate study visits, procedures, infusions, labs, and follow-ups
Ensure protocol-specific procedures are completed accurately and within required timelines
Study Start-Up & Regulatory Support
Assist with study start-up activities, including feasibility assessments, site readiness tasks, and workflow development
Prepare and maintain regulatory documents including investigator site files (ISFs), delegation logs, training logs, and essential documents
Support IRB submissions, amendments, renewals, and continuing reviews as directed
Ensure staff training documentation is current and protocol-specific training is completed
Data Management & Documentation
Accurately collect, enter, and maintain study data in EDC systems and source documents
Ensure data accuracy, completeness, and timeliness in compliance with GCP and protocol requirements
Respond to data queries and collaborate with monitors and sponsors during monitoring visits
Maintain organized and audit-ready study documentation
Clinical & Operational Collaboration
Collaborate closely with infusion nurses, providers, and research leadership to coordinate study-related care
Communicate effectively with sponsors, CROs, and monitors regarding study progress and issues
Assist with investigational product accountability, documentation, and coordination with pharmacy or nursing staff as applicable
Patient Education & Support
Educate study participants on protocol requirements, visit expectations, and study procedures
Serve as a primary point of contact for research participants throughout study participation
Ensure participant safety, confidentiality, and informed consent compliance at all times
Compliance & Quality
Ensure compliance with study protocols, GCP guidelines, HIPAA regulations, and institutional policies
Maintain confidentiality of patient and study information
Assist with monitoring visits, audits, and inspections as required
Identify protocol deviations and escalate concerns to research leadership
Daily / Ongoing Responsibilities
Track study milestones including enrollment, visits, and follow-ups
Maintain study calendars and visit schedules
Assist with ordering and tracking study supplies and materials
Perform assigned clerical duties including filing, scanning, copying, and data organization
Support infusion and clinical teams with research-related coordination needs
Physical Demands
Work involves sitting, standing, and walking throughout the day. Visual acuity, auditory acuity, and manual dexterity are required for data entry and documentation. Minimal lifting may be required.
Position Type/Expected Hours of Work
Full-time position. Typical hours are Monday through Friday. Evening hours may be required based on study or operational needs.
OSHA Exposure Classification:
Job Category I. Direct contact with blood or other body fluids (Bloodborne Pathogens) to which Universal Precautions apply. Personal protective equipment is made available and must be worn.
Travel
Travel may be required to satellite infusion or research locations or for sponsor meetings and training.
Required Education and Experience
Associate’s or Bachelor’s degree in a health-related or science field preferred
Prior experience in clinical research coordination preferred
Knowledge of GCP, IRB processes, and clinical research regulations preferred
Experience with EMR and EDC systems preferred
Strong organizational, communication, and documentation skills
Other Duties
Please note 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. Duties, responsibilities and activities may change at any time with or without notice.