Clinical Research Technician Underfill Assistant-Term Limited

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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

The research assistant will support wet-laboratory studies focused on bone and joint biology, including tissue processing, cell culture, molecular assays, histology, and analysis of musculoskeletal specimens. Responsibilities will also include assisting with experimental design, data collection and analysis, laboratory maintenance, and research projects investigating mechanisms of bone and joint injury, degeneration, and regeneration.

Responsibilities*

Clinical Research Assistant:

BASIC FUNCTION AND RESPONSIBILITY

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.

CHARACTERISTIC DUTIES AND RESPONSIBILITIES

Knowledge of all 8 competency domains is expected and experience within applicable domains specific to unit needs. *

1. Scientific Concepts and Research Design

2. Ethical Participant Safety Considerations

3. Investigational Products Development and Regulation

4. Clinical Study Operations (GCPs)

5. Study and Site Management

6. Data Management and Informatics

7. Leadership and Professionalism

8. Communication and Teamwork

Essential

20% 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.

20% 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)

20% 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.)

30% 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.)

10% 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 documentregarding 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

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.

Clinical Research Technician:

BASIC FUNCTION AND RESPONSIBILITY

This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the Clinical Research Technician position is required.

CHARACTERISTIC DUTIES AND RESPONSIBILITIES

Experience as part of a team with all 8 competency domains is expected. *

1. Scientific Concepts and Research Design

2. Ethical Participant Safety Considerations

3. Investigational Products Development and Regulation

4. Clinical Study Operations (GCPs)

5. Study and Site Management

6. Data Management and Informatics

7. Leadership and Professionalism

8. Communication and Teamwork

Essential:

25% Clinical Coordinator Responsibilities (ex. ? Performs moderately complex study procedures with accuracy; Triages simple subject concerns and issues appropriately; Assesses studies for execution and troubleshoots potential implementation issues; Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.)

• Performs moderately complex study procedures with accuracy.
• Triages simple subject concerns and issues appropriately.
• Assesses studies for execution and troubleshoots potential implementation issues.
• Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.
• Completes simple to moderately complex data collection during study visits.
• May work with CTSUs to reconcile financial accounts for study participants.
• Assists with local quality control efforts.
• May create a recruitment plan that addresses the needs of the study population and develop materials for IRB submission that will aid in recruitment

25% Data Coordinator Responsibilities (ex. ? Completes simple to moderately complex data collection during study visits; Resolves simple data queries)

May work with Office of Research Compliance to create and post studies in ClinicalTrials.gov.

• May obtain the CTN number for eResearch applications.
• Completes simple to moderately complex CRFs
• Can resolve simple to moderately complex queries (e.g., data error changed numerous values in EDC)
• May assist in CRF development for Investigator Initiated trials.

25% Regulatory Coordinator Responsibilities (ex. ? Submission and management of IRB applications; Identify Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Events (ORIOs) and report appropriately.)

• May complete new eResearch applications.
• May maintain essential regulatory documents as outlined in the ICH-GCP guidelines.
• May gather participant approval via informed consent.
• Prepares and participates in internal and external audits.
• Demonstrates ability to manage increasing levels of protocol complexity or volume efficiently.
• Demonstrates ability to identify Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Events (ORIOs), and understands how to report appropriately.

15% Administrative Responsibilities (ex. Provide other administrative support for study activity including scanning, filing, etc. of research documents as well as preparing, processing, and shipping biospecimens.)

• 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.)

10% Training (ex. Participates in training opportunities on Good Clinical Practices (GCP))

• All training requirements of previous level.
• 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. Assists with training activities of staff and others.

Required Qualifications*

REQUIRED QUALIFICATIONS

Clinical Research Assistant:

High school diploma or GED

Clinical Research Technician:

Associate degree in Health Science or an equivalent combination of related education and experience is necessary.

Minimum 1 year of directly related experience in clinical research and clinical trials is necessary (Please review SoCRA?s Definition of a Clinical Research Professional for qualifying experience prior to applying.)

or

An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD

or

Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.

Desired Qualifications*

Clinical Research Assistant:

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.

Clinical Research Technician:

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.

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

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.

Underfill Statement

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

Additional Information

Please note: This will be a 1 year, term-limited appointment that runs through 11/1/2027. At the end of the stated term, your appointment will terminate and will not be eligible for Reduction-in-Force (RIF) benefits. This term-limited appointment does not create a contract or guarantee of employment for any period of time as you will remain subject to disciplinary or other performance measures, up to and including termination, at the will of the University in accordance with existing University policy and standards for employee performance and conduct.

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 any time after the minimum posting period has ended.

U-M EEO Statement

The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.