University of Michigan-Flint School of Management
Clinical Research Coord Assoc
University of Michigan-Flint School of Management, Ann Arbor, Michigan, us, 48113
Clinical Research Coordinator Associate – University of Michigan‑Flint School of Management
Emergency Medicine seeks an experienced Clinical Research Coordinator to support multiple study projects within the Traumatic Brain Injury Program. The role involves study planning, IRB management, patient recruitment, consenting, enrollment, lab procedures, data collection, and independent coordination of simple to moderately complex clinical research studies.
Responsibilities
Apply independent knowledge across all eight competency domains (Scientific Concepts and Research Design; Ethical Participant Safety; Investigational Products Development and Regulation; Clinical Study Operations (GCPs); Study and Site Management; Data Management and Informatics; Leadership and Professionalism; Communication and Teamwork).
Ensure regulatory compliance: prepare/wrap IRB protocols, maintain documentation (applications, amendments, reviews, progress reports, safety reports, adverse events), and communicate regularly with the IRB.
Create and maintain study SOPs/protocols and research binders.
Conduct literature reviews and accurately complete study tracking documentation.
Maintain project tracking systems and consult with investigators to ensure protocol alignment.
Coordinate study operations: screen potential subjects, consent/enroll participants, collect demographic data, conduct follow‑up assessments, manage specimen collection and storage, monitor safety, and oversee daily operations.
Develop, design, and conduct small or moderately complex research projects, review progress, evaluate results, and recommend improvements.
Work independently and collaboratively, exercise good judgment, resolve operational problems, and maintain confidentiality.
Support studies within Emergency Medicine, covering evening and weekend shifts and cross‑training with other staff.
Perform additional tasks as required.
Required Qualifications
Excellent interpersonal, oral, and written communication skills with meticulous attention to detail.
Highly organized, self‑motivated, and proficient in Microsoft Office and other computer applications.
Ability to manage multiple tasks/projects simultaneously, prioritize, and exercise sound judgment.
Work independently with minimal supervision while collaborating effectively with a diverse team.
Adhere to confidentiality, meet deadlines, and prioritize tasks.
Comfortable working in the Emergency Department, interacting with diverse populations, and discussing sensitive topics.
Associate
Bachelor’s degree in Health Science or equivalent education/experience.
Certification as a Certified Clinical Research Coordinator (CCRC) through ACRP or a Certified Clinical Research Professional (CCRP) through SOCRA, completed within six months of hire.
Minimum 2 years of directly related clinical research experience.
Technician
Associate degree in Health Science or equivalent education/experience.
One of the following:
Minimum 1 year of directly related clinical research experience.
An advanced degree in a health‑related area (Health Sciences, Behavioral Sciences, Public Health, etc.).
Minimum 3 years of human subject experience in clinical, lab, or health regulations.
Assistant
High school diploma or GED required.
Desired Qualifications
Previous clinical research or related volunteer experience; familiarity with research protocols.
Ability to function independently with limited supervision after onboarding.
Experience with Epic, MiChart, eResearch applications, and regulatory compliance processes.
Experience with REDCap, Qualtrics, or similar data capturing systems.
Working Conditions Onsite 8‑hour shifts, 40 hours per week, with routine evening and weekend coverage required.
Background screening and pre‑employment drug testing will be conducted for all selected candidates.
EEO Statement The University of Michigan is an equal employment opportunity employer.
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Responsibilities
Apply independent knowledge across all eight competency domains (Scientific Concepts and Research Design; Ethical Participant Safety; Investigational Products Development and Regulation; Clinical Study Operations (GCPs); Study and Site Management; Data Management and Informatics; Leadership and Professionalism; Communication and Teamwork).
Ensure regulatory compliance: prepare/wrap IRB protocols, maintain documentation (applications, amendments, reviews, progress reports, safety reports, adverse events), and communicate regularly with the IRB.
Create and maintain study SOPs/protocols and research binders.
Conduct literature reviews and accurately complete study tracking documentation.
Maintain project tracking systems and consult with investigators to ensure protocol alignment.
Coordinate study operations: screen potential subjects, consent/enroll participants, collect demographic data, conduct follow‑up assessments, manage specimen collection and storage, monitor safety, and oversee daily operations.
Develop, design, and conduct small or moderately complex research projects, review progress, evaluate results, and recommend improvements.
Work independently and collaboratively, exercise good judgment, resolve operational problems, and maintain confidentiality.
Support studies within Emergency Medicine, covering evening and weekend shifts and cross‑training with other staff.
Perform additional tasks as required.
Required Qualifications
Excellent interpersonal, oral, and written communication skills with meticulous attention to detail.
Highly organized, self‑motivated, and proficient in Microsoft Office and other computer applications.
Ability to manage multiple tasks/projects simultaneously, prioritize, and exercise sound judgment.
Work independently with minimal supervision while collaborating effectively with a diverse team.
Adhere to confidentiality, meet deadlines, and prioritize tasks.
Comfortable working in the Emergency Department, interacting with diverse populations, and discussing sensitive topics.
Associate
Bachelor’s degree in Health Science or equivalent education/experience.
Certification as a Certified Clinical Research Coordinator (CCRC) through ACRP or a Certified Clinical Research Professional (CCRP) through SOCRA, completed within six months of hire.
Minimum 2 years of directly related clinical research experience.
Technician
Associate degree in Health Science or equivalent education/experience.
One of the following:
Minimum 1 year of directly related clinical research experience.
An advanced degree in a health‑related area (Health Sciences, Behavioral Sciences, Public Health, etc.).
Minimum 3 years of human subject experience in clinical, lab, or health regulations.
Assistant
High school diploma or GED required.
Desired Qualifications
Previous clinical research or related volunteer experience; familiarity with research protocols.
Ability to function independently with limited supervision after onboarding.
Experience with Epic, MiChart, eResearch applications, and regulatory compliance processes.
Experience with REDCap, Qualtrics, or similar data capturing systems.
Working Conditions Onsite 8‑hour shifts, 40 hours per week, with routine evening and weekend coverage required.
Background screening and pre‑employment drug testing will be conducted for all selected candidates.
EEO Statement The University of Michigan is an equal employment opportunity employer.
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