Michigan Medicine · 20 hours ago
Clinical Research Assistant
Ann Arbor, MI
Full-time
Hybrid
New Grad, Entry LevelMichigan Medicine is one of the largest health care complexes in the world, and they are seeking a Clinical Research Assistant to provide administrative and coordination support for clinical research projects. The role involves assisting with study coordination, participant recruitment, data collection, and ensuring compliance with research protocols.
EducationHealthcareHealth CareMedical
Responsibilities
Knowledge of all 8 competency domains is expected and experience within applicable domains specific to unit needs
Scientific Concepts and Research Design
Ethical Participant Safety Considerations
Investigational Products Development and Regulation
Clinical Study Operations (GCPs)
Study and Site Management
Data Management and Informatics
Leadership and Professionalism
Communication and Teamwork
Communicate and collaborate with both academic and community partners to conduct research
Organize logistics for study procedures, including recruitment of participants to study-related activities, obtaining written informed consent, and drafting submissions to the Institutional Review Board
Meet with study team regularly (virtual option will be available) to strategize and monitor recruitment and study related procedures but some in person meetings may be required
Assist with writing project updates as required by funders
Adhere to the Health Insurance Portability and Accountability Act (HIPAA) of 1996 in order to maintain patient confidentiality
Communicate effectively and professionally with people, members of the health care team and project leadership
Contribute to scholarship activities, including presentations and manuscript development
Ethical Participant Safety Considerations
Quantitative and qualitative data collection (survey administration, focus group/interview analysis, electronic health record results)
Demonstrates ability to screen participants for study eligibility & enroll with accuracy in various databases
Performs simple study procedures with accuracy
Understands protocol structure and how to interpret study requirements to ensure study compliance
Understands proper documentation techniques as outlined in the ICH-GCP guidelines
May complete simple study reimbursement with partners such as the Human Subjects Incentive Program (HSIP) and the CTSU finance team
Demonstrates the ability to find and utilize information from EMR and databases/CTMS/EDC
May mark visits as planned/occurred in OnCore
May provide lab results, not interpretation, to participants
May maintain essential regulatory documents
May assist research coordinator in conduct of SIV; attends SIV
May assist in and attends monitor visits and or audits
May conduct site selection/qualification visits for potentially incoming clinical trials
Demonstrates the ability to complete simple data collection during study visits (e.g., basic demographic information)
Enters data to complete forms (CRFs) on paper, databases, or EDCs
Assists with collection of external medical records, CLIAs, CAPs, and radiology CDs as assigned
May administer minimal risk consents, surveys, and questionnaires
Checks own work and confirms accuracy
Demonstrates ability to perform concomitant medications abstraction
Uses various NCI AE grading scales
Builds patient research study charts
Demonstrates ability to resolve simple queries
Assists in quality control efforts (e.g., review of consents for signatures)
May work with regulatory support to collect essential documents and maintain regulatory binder (CVs, MD licenses, lab certifications, IRB rosters, lab norms, etc.); Assists with AEs and SAEs, ORIOS reporting; Uses proper documentation techniques as outlined in the ICH-GCP guidelines
Provide other administrative support for study activity including scanning, filing, etc. of research documents; managing organization of research kits
Demonstrates understanding of the clinical research objectives associated with the program
May communicate with study participants such as sending study correspondence via mail or email
May schedule subjects for research visits and FU appointments
May check study calendar for completion of study procedures
May manage study supply inventory
May utilize documents and systems to track recruitment and retention of participants
May complete and activate postings (advertisements, flyers, etc.) independently
May work with regulatory support to maintain regulatory binder (CVs, MD licenses, lab certifications, IRB rosters, UM lab norms, etc.)
May receiving task specific training to perform additional research duties as assigned
Gains appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assigned
Willing to learn and use available technology and systems to accomplish job requirements
Understands the disease process per program
Attends and participates in all training classes assigned to this level
Demonstrates proficiency in eResearch duties as assigned
Uses proper documentation techniques as outlined in the ICH-GCP guidelines
May gather participant approval via a simple consent
May assess participant understanding of the research during the consent process and can therefore consent to the study
Demonstrates ability to identify AEs and SAEs, ORIOS, and assists with reporting
May submit continuing reviews, amendments, and post correspondence in eResearch
Demonstrates familiarity with essential documents as described in the ICH-GCP guidelines
Demonstrates the ability to understand the completion and submission of eResearch and OnCore applications
Can explain the basic requirements of an Informed Consent and the importance of such a document regarding the safety and ethical treatment of participants
Identifies key regulations and guidelines in FDA and ICH documents that ensure ethical conduct in clinical trials
Understands importance of participant confidentiality and complies with HIPAA and U of M regulations
Demonstrates professional behavior and ethical integrity through the applications of all established processes and procedures related to the ethical treatment of participants
Suggests modifications to improve efficiency of workload and/or workflow
May assist research team in the conduct of site initiation meetings
May conduct site selection/qualification visits for potentially incoming clinical trials
May communicate with MCRU or other staff completing specimen management to collect data (e.g., pick up/retrieve CRFs from staff, track packages, etc.)
Ensures integrity of specimen management (collection, processing, packaging/shipping, storing, labeling, tracking, etc.)
Is familiar with basic clinical lab equipment such as a centrifuge, freezers (various), pipettes, and standard laboratory safety requirements and guidelines
May prepare study procedure kits, shippers, CRFs, and requisition forms
Perform other related duties as assigned
Qualification
Required
High school diploma or GED is necessary
Some work experience in research or related technical fields (community outreach, cancer prevention and control, community health work)
CITI training (can be completed during on-boarding or immediately after starting the position if not already completed)
Access to reliable and independent transportation (with mileage reimbursement through the university)
Preferred
Associate or Bachelor Degree in Health Science or an equivalent combination of related education and experience is desirable
An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable
Prior experience with IRB protocol/submissions, informed consent and electronic health record navigation
Benefits
Excellent medical, dental and vision coverage effective on your very first day
2:1 Match on retirement savings
Company
Michigan Medicine
Michigan Medicine is a health care system and academic medical center that provides medical education and more. It is a sub-organization of University of Maichigan.
Founded in 1869
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Heather Ascani
Director, Business Strategy - Michigan Kidney Translational Research Core
Jack Kufahl
Chief Information Security Officer
Recent News
2025-12-11
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