Clinical Research Technician Underfill Assistant-Term Limited

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. *

• 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

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 includin…