Clinical Research Technician / Assistant (underfill)

How to Apply

A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

Job Summary

This position may independently provide study coordination for simple and moderately complex clinical research studies. Seeking highly motivated, positive, organized, and autonomous individual. As a member of this team, you will collect primary data, schedule participants, assist with regulatory preparations, prepare data to be analyzed, along with addition responsibilities as needed.

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:

• 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

Project Management

• Assist in creating policies and procedures
• Screen, Recruit, Provide Informed consent, and enroll participants according to protocol for clinical studies.
• Schedule participant study visits in coordination with laboratory and other clinical staff.
• Directly interact with subjects in a clinical setting administering survey instruments.
• Track and monitor participants, relay results to the clinical team.
• Manage regulatory requirements including IRB submissions in eResearch Regulatory Management system., collection of essential regulatory documents, execution of study protocol, and preparation for sponsor monitoring
• Track ongoing presentations, posters, manuscripts for multiple projects

Data Management

• Collect primary data (e.g., administer questionnaires, perform survey research)
• Collect and record participant study-related data.
• Collect, process, label, store study related products.
• Complete and document participant compensation according to requirements
• Perform data management such as creating a database, cleaning data, or merging datasets
• Entering research data and managing databases
• Maintaining accurate and detailed databases
• Ensure all study related documentation is completed accurately with quality and in a timely fashion per requirements. Electronic and/or paper data entry into case report forms
• Maintain confidentiality and protect the privacy of others.
• Continue to maintain certifications and continuing education

Data Analysis

• Prepare data to be analyzed by study coordinators
• Assist in data processing
• Conduct preliminary data analysis

Research

• Preform clinical study supply organization and clinic room preparation.
• Consenting research study subjects
• Work with IRB adverse event reports
• Act in accordance with all relevant human subject regulations, identify potential protocol problems and, in collaboration with the PI, work to resolve those problems.

Supervision Received: This position receives direct supervision and reports directly to (Faculty Principal Investigator).

Supervision Exercised: None

Required Qualifications*

Technician Level:

• 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 SoCRAs 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.

Assistant Level:

• High school diploma or GED is necessary.

Both:

• An understanding of medical terminology, experience in a large complex health care or large corporation setting, ability to effectively communicate with staff and faculty of all levels, and awareness of policies and procedures
• Experience and understanding of clinical research or clinical trials
• Experience with personal information up to and including protected health information
• Experience of participating in the writing or editing of manuscripts and progress reports
• Demonstrated good judgment and strong problem-solving skills
• Familiarity with database systems and entry including one or more of the following: Oracle, REDCap, OnCore, Epic, MiChart, and eResearch applications.
• Proven experience in administering regulatory requirements and protocols

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.

Technician Level:

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

Assistant Level:

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

Work Schedule

Weekdays day shift. Alterations to this schedule may be required as the Principal Investigator deems necessary.

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.

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 Statement

The University of Michigan is an equal employment opportunity employer.