Clinical Research Technician/Assistant

Summary
CRC-Technician Title:
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 CRC-Assistant position on the Michigan Medicine CRC Career Ladder is required.
CRC-Assistant Title:
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.
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*
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

We are looking for a full-time (100% effort) coordinator for Initiation and development of the Clinical Research project. The role of circulating meta-inflammatory monocytes in adolescent insulin resistance. The coordinator will work in collaboration with the research Principal Investigator by participating in initiation of projects, budget reviews, IRB readiness, database maintenance, coordination of recruitment, sample management and following participants through the study.
Specific duties include:
Prepare and organize space for study related materials and equipment to accomplish the following:

• Identify, screen and enroll potential subjects; consent minimal risk subjects
• Perform data management, such as entering information into a RedCap Database
• Maintain a good rapport and communication with research cores, support offices, teams and faculty, as well as patients and families
• Work with trainees who will support recruitment, nutrition staff for planning mixed meal tolerance testing and Clinical Research units for study scheduling.

Collect and assist in the management of patient data for Clinical Research subjects.

• Foster a relationship with clinic staff and physicians to support recruitment and consent into the study.
• Build a relationship with participants and family to be able to answer questions, ease fears and provide support. This will including meeting with participants during the face to face visits of metabolic testing.
• Schedule study activities with participants and families then provide reminder emails, phone calls, text messages and communicate with the lab to ensure participant visits are scheduled and samples are processed in a timely manner within the study protocol.
• Collection of patient bio specimens and disease activity measures; ensure integrity of specimens (collection, processing, shipping/packing, storing, labeling, tracking, etc)

Ongoing study support

• Report to the PI weekly to discuss recruitment numbers, issues, progress, and adverse events.
• Coordinate DSMP meetings
• Create and maintain a study timeline to ensure objectives and recruitment targets are being met
• Provide the participants with incentives and maintaining records
• Update clinicaltrials.gov

Support the preparation for IRB audit and monitor

• Assist in the preparation of IRB amendments and scheduled continuing reviews, progress reports, safety reports and adverse event reports
• In coordination with other Clinical Trials Support Units (CTSU) staff, communicate with sponsors concerning progress of Clinical Research, billing calendar/budget issues, subject related problems, recruitment strategies, and specific policies and procedures
• Act as liaison between study team and sponsors, IRB, federal, state, and University officials and other regulatory agencies to maintain accurate communication of costs, policy changes, fiscal requirements and other regulatory issues
• Support the PI in creating and submitting NIH reports
• Assist in the training of other research staff in the research program

Assist with writing Clinical Trials Protocols and/or Abstracts/Manuscripts.
Supervision Received:
This position receives direct supervision and reports directly to the Faculty Principal Investigator and the Administrative Director.
Supervision Exercised:
None.
Required Qualifications*
CRC-Technician Title:

• 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;

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

CRC-Assistant Title:

• High school diploma or GED is necessary

Other required qualifications:

• Excellent interpersonal, oral, and written communication skills
• Proficient computer skills including Microsoft software applications
• Experience of participating in the writing manuscripts and progress reports
• Ability to organize/prioritize tasks effectively and efficiently
• Demonstrated ability to manage work across a set of diverse stakeholders (e.g., study subjects, research assistants, research investigators, regulatory staff/agencies)
• Ability to set goals, exercise sound professional judgment, and problem-solve within delegated authority
• Ability to work independently to meet milestones and deadlines
• Solid attendance record and work ethics

Desired Qualifications*
CRC-Technician Title:

• Bachelor's degree in Health Science or an equivalent combination of related education and experience is desirable.

CRC-Assistant Title:

• Associate Degree in Health Science or an equivalent combination of related education and experience is desirable.

Other desired qualifications:

• 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.
• Reasonable understanding of Clinical Research or clinical trials. This study will have several tasks that will require consistent communication and coordination of participant data and sample/data management
• Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) certification
• Demonstrated good judgment and strong problem solving skills related to Clinical Research experience
• Good understanding of medical terminology - ideally in the field of nutrition or metabolic health
• Familiarity with REDCap, OnCore, Epic, MiChart, and eResearch applications
• Some knowledge of UMHS policies and practice
• Proven experience in administering IRB/regulatory requirements and protocols

Underfill Statement
This position may be underfilled at the CRC-Assistant title based on selected candidates' qualifications.
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/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.
Job Detail
Job Opening ID
242568
Working Title
Clinical Research Technician/Assistant
Job Title
Clinical Research Technician
Work Location
Ann Arbor Campus
Ann Arbor, MI
Full/Part Time
Full-Time
Regular/Temporary
Regular
FLSA Status
Nonexempt
Organizational Group
Medical School
Department
MM Pediatrics-Endocrinology
Posting Begin/End Date
12/05/2023 - 12/19/2023
Career Interest
Research