"Clinical Research Assistant"

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.

This position is ideally suited for an individual who is passionate about both health center and community-based work in underserved groups with health disparities and can multitask simultaneous involvement across a number of ongoing projects. The research area for current projects include social determinants of health, health services, clinical trials and community-based participatory research which are focused on substance use disorders, liver disease and underserved communities. Current studies include evaluation of an integrated multidisciplinary collaborative care model in the UM alcohol-associated liver disease program, recruiting patients with liver disease into prospective liver trials and database registry, clinical trials testing novel therapeutics in patients with liver disease in the hospital and clinic settings and working with Michigan tribal communities to improve substance use disorder care and treatment. The research coordinator shall assure the success of these projects by working closely with the PI and entire study teams to achieve grant deliverables such as 1) research administrative responsibilities (IRB protocol development, submission and all related requirements), 2) recruiting participants for qualitative and quantitative study procedures, 3) collecting data and doing descriptive data analysis, 3) preparation of study reports, 4) involvement in dissemination of study findings and 5) organizing team and study related activities (focus groups, community advisory meetings) and meetings. While manuscript development, IRB submission, and EMR charting are examples of work that can be completed remotely, the research coordinator must also be able to travel onsite for patient recruitment and data collection for select studies.

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

Additional duties include:

• 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)

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.
• 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)

Desired Qualifications

• 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

This is a hybrid position with onsite work divided between the study location and Michigan Medicine.

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.