Job Description

How to Apply

A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Job Summary

This is the entry level position on the Michigan Medicine CRC Career Ladder. This position provides administrative and coordination support for multiple projects in the conduct of clinical research projects. This position may assist with study coordination but will not be assigned clinical trials independently. This position may provide coordination for clinical research projects such as registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies. This position is part of the Michigan Clinical Trial Support Unit (M-CTSU) CRC team that supports various departments and divisions withing Michigan Medicine.

Characteristic Duties And Responsibilities

Knowledge of all 8 competency domains is expected:

• 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

Responsibilities*

Clinical Coordinator Responsibilities

• 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.

Data Coordinator Responsibilities

• 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)

Regulatory Coordinator Responsibilities (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.)

Administrative Responsibilities (ex. ? 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.)

Training (ex. ? May receiving task specific training to perform additional research duties as assigned.)

• PEERRS, HIPAA, CITI GCP
• 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.

Related Duties

Ethics and Participant Safety

• 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

Operations

• 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.

Other

• Perform other related duties as assigned.

Supervision Received

This position receives direct supervision and reports directly to the M-CTSU unit CRC Administrator.

Supervision Exercised

None

Required Qualifications*

• High School Diploma or GED

Desired Qualifications*

• Bachelor's 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.

Modes of Work

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.

Work Schedule

This position supports normal business hours, Monday - Friday with rare occasional early mornings or late afternoon's depending on patient schedules. This is an on-campus position with opportunity for remote work.

Work Locations

Ann Arbor

Additional Information

Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO Statement

The University of Michigan is an equal employment opportunity employer.

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