Clinical Research Assistant

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Summary

This is an entry level position that 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.

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.

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world’s most distinguished academic health systems.  In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

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

Clinical Coordinator Responsibilities (ex. Assist with screening participants for study eligibility & enroll with accuracy in various databases; May complete simple study reimbursement with partners; May provide lab results, not interpretation, to participants)

• 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 (ex. May assist research coordinator in conduct of SIV; attends SIV; Enters data to complete forms (CRFs) on paper or in EDC)

• 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 (ex. 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.

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.

Required Qualifications*

High school diploma or GED is necessary.

Desired Qualifications*

Associate 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.

Work Schedule

Normal work schedule is onsite 8 a.m. to 4:30 p.m., Monday through Friday.

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. 

SUPERVISION RECEIVED
This position receives direct supervision and should report directly to a Clinical Research Coordinator Lead, Clinical Research Project Manager, Administrator, or Faculty Principal Investigator.

DISCLAIMER: This description is intended to indicate the kinds of tasks and levels of work difficulty that will be required of positions that will be given this title and shall not be construed as declaring what the specific duties and responsibilities of any position shall be. It is not intended to limit or in any way modify the right of any supervisor to assign, direct, and control the work of employees under his supervision. The use of a particular expression or illustration describing duties shall not be held to exclude other duties not mentioned that are of a similar kind or level of difficulty.

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/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.