Clinical Research Technician/Assistant

University Of Michigan; Ann Arbor (MI); Hybrid; USD 50,000 - 80,000; Full time

Job summary

Join a prestigious academic health system as a Clinical Research Coordinator, where you'll play a vital role in advancing pediatric rheumatology research. This full-time position offers a dynamic work environment, allowing you to contribute to groundbreaking studies while collaborating with a dedicated team. You'll manage patient data, assist in study coordination, and ensure compliance with regulatory standards. Embrace the opportunity to make a meaningful impact in the lives of patients and families, all while enjoying comprehensive benefits and a supportive work culture. Your journey towards making a difference starts here!

Benefits

Excellent medical, dental and vision coverage

2:1 Match on retirement savings

Qualifications

• Minimum 1 year of clinical research experience required.
• Excellent communication and teamwork skills are essential.

Responsibilities

• Coordinate clinical research studies and manage patient data.
• Collaborate with research teams and maintain communication with stakeholders.

Skills

Interpersonal Communication

Organizational Skills

Data Management

Clinical Research Knowledge

Team Collaboration

Education

Associate Degree in Health Science

Bachelor's Degree in Health Science

Advanced Degree in Health-Related Areas

Tools

REDCap

Epic

OnCore

MiChart

Job description

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.

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 30,000employees 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*

Characteristic Duties and Responsibilities:

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

• 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

We are seeking a motivated clinical research professional who enjoys patient-oriented, collaborative translational science and desires to contribute to research in a team-based environment. The Clinical Research Coordinator will join the translational research team led by Dr. Jessica Turnier within the growing Pediatric Rheumatology Research Program at the University of Michigan. Dr. Turnier is a Pediatric Rheumatologist, and her research focuses on understanding the biochemical and cellular pathways underlying skin and systemic inflammation in juvenile myositis and lupus. Dr. Turnier?s lab applies molecular and bioinformatic approaches to analysis of biosamples from a longitudinal cohort of juvenile myositis and lupus patients to better understand treatment response and develop novel therapeutic targets and biomarkers.

The Pediatric Rheumatology Clinical Research Coordinator will play a central role in the delivery of high-quality results in the following key responsibilities:
Prepare, manage, 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 Case Report Forms (CRFs)
• Work collaboratively with the CTSU team by maintaining a good rapport and communication with research teams and faculty, as well as patients and families
• Coordination of multicenter study and patient engagement efforts

Collect and manage patient and laboratory data for clinical research subjects

Collection of patient bio specimens and disease activity measures; maintainoversight to ensure integrity of specimens (collection, shipping/packing, storing, labeling, tracking, etc).

Processing of patient bio specimens including:

• Centrifugation, cell isolation, and freezing of patient specimens
• Labeling and tracking of samples in Freezer works

Assist withdeveloping and writing Abstracts/Manuscripts and/or Clinical Trials Protocols.

Support the preparation for IRB audit and monitor:

• Assist in the preparation of IRB applications, amendments and scheduled continuing reviews, progress reports, safety reports and adverse event reports
• In coordination with other 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
• Assist in the training ofother research staff in the research program

Supervision Received:

This position receives direct supervision and reports directly to (a CRC-Lead, CRC-Project Manager, a unit Administrator, Director, or Faculty Principal Investigator).

Supervision Exercised:

None.

Required Qualifications*

• Excellent interpersonal, oral, and written communication skills
• Proficient computer skills including Microsoft software applications
• 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 withindelegated authority
• Ability to work independently tomeet milestones and deadlines
• Solid attendance record and work ethics
• 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, HealthCare 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
• High school diploma or GED is necessary.

Desired Qualifications*

• 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
• Experience and understanding of pediatric clinical research and Rheumatology patient care
• Experience with the University of Michigan eResearch system
• Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) certification
• Experience ofparticipating inthewriting manuscripts and progress reports
• Demonstrated good judgment and strong problem solving skills related to clinical research experience
• Good understanding of medical terminology
• Familiarity with REDCap, OnCore, Epic, MiChart, and eResearch applications
• Some knowledge of UMHS policies and practice
• Proven experience in administeringIRB/regulatory requirements and protocols

Work Schedule

The position is full-time. The work schedule will typically be Monday-Friday, 8-hour shifts. However, flexibility on weekends and evenings may be required depending on study needs.

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 the CRC-Assistant title based on selected candidates’ qualifications.

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 maybegin as early as the eighth day after posting.Thisopening may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO Statement

The University of Michigan is an equal employment opportunity employer.