CRC Technician/Assistant

University of Michigan; Ann Arbor (MI); On-site; USD 52,000 - 68,000; Full time

Benefits offered by this job

Excellent medical, dental and vision -

2:1 retirement match

Job summary

The University of Michigan's Michigan Medicine is seeking a Clinical Research Coordinator Assistant to independently support study coordination for simple to moderately complex clinical trials. You will join a coordination team and contribute across the portfolio under the CRC Career Ladder, mastering duties and ensuring data quality and participant safety.

Responsibilities include screening and enrolling subjects, IRB submissions, data management, and collaboration with sponsors, IRB, and

Qualifications

• Associate’s Degree or equivalent in combined education and clinical research experience.
• Minimum of 1+ years direct related experience OR advanced degree in health-related areas OR 3 years of related human subjects experience
• Underfill requirement
• High School Diploma or GED
• Bachelor’s Degree in Health Science or an equivalent combination of related education and experience is desirable
• An understanding of medical terminology preferred
• Knowledge of Michigan Medicine policies and practice
• Familiarity with OnCore, Epic, MiCHART, and eResearch applications
• PEERS, CITI, or NIH Protection of Human Subjects Training Certification
• Experience with local and central IRB application processes
• Motivated to help others

Responsibilities

• Assist study team with identifying potential subjects, screening subjects, consenting and enrolling subjects.
• Collect and manage patient and laboratory data for clinical research subjects.
• Prepare IRB submissions including initial applications, amendments and scheduled continuing reviews, progress reports, safety reports, and adverse event reports.
• In coordination with other M-CTSU staff, communicate with sponsors concerning progress of clinical trials, 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.
• Provide support for audits and monitor visits.
• Work collaboratively with the M-CTSU team by maintaining a good rapport and communication with research teams and faculty, as well as patients and families.
• Prepare and organize space for study related materials and equipment.
• The person in this position will frequently traverse around the medical campus and will occasionally spend long hours (full days) on their feet.
• Staff members are expected to work independently and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while always maintaining the strictest of confidentiality.
• This person may help mentor and train other CRC staff through formal and informal presentations.
• Other administrative responsibilities as assigned.

Skills

Scientific Concepts and ResearchDesign

Ethical Participant Safety Consider-

Investigational Products Development-

Clinical Study Operations (GCPs)

Study and Site Management

Data Management and Informatics

Leadership and Professionalism

Communication and Teamwork

Education

Associate’s Degree or equivalent in combined education and clinical research experience

High School Diploma or GED

Bachelor’s Degree in Health Science

Tools

OnCore

Epic

MiCHART

eResearch applications

PEERS

CITI Training

Job description

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.

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

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.

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

Assist study team with aspects of clinical research coordination including: identifying potential subjects, screening subjects, consenting and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects.

Collect specimens and monitor study subjects.Assist in monitoring of test results.Ensure integrity of specimens (collection, processing, shipping/packing, storing, labeling, tracking, etc.).

Perform data management and results reporting, such as entering information into Case Report Forms (CRFs). Assist with collection of external medical records for study reporting purposes. Ability to identify and report Adverse Events (AEs) and Serious Adverse Events (SAEs).

Prepare IRB submissions including the initial applications, as well as amendments and scheduled continuing reviews, progress reports, safety reports, and adverse event reports.

In coordination with other M-CTSU staff, communicate with sponsors concerning progress of clinical trials, 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. Serve as key resource to research participants and collaborators. Provide support for audits and monitor visits.

Work collaboratively with the M-CTSU team by maintaining a good rapport and communication with research teams and faculty, as well as patients and families.

Prepare and organize space for study related materials and equipment.

The person in this position will frequently traverse around the medical campus and will occasionally spend long hours (full days) on their feet. There is a need to move, transport, and position clinical research supplies weighing up to 50 pounds across the hospital campus.

Staff members are expected to work independently and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while always maintaining the strictest of confidentiality.

This person may help mentor and train other CRC staff through formal and informal presentations.

Other administrative responsibilities as assigned.

Required Qualifications*

Associate?s Degree or equivalent in combined education and clinical research experience

Minimum of 1+ years direct related experience OR advanced degree in health-related areas OR 3 years of related human subjects experience

Underfill requirement

High School Diploma or GED

Desired Qualifications*

Bachelor?s Degree in Health Science or an equivalent combination of related education and experience is desirable

An understanding of medical terminology preferred

Knowledge of Michigan Medicine policies and practice

Familiarity with OnCore, Epic, MiCHART, and eResearch applications

PEERS, CITI, or NIH Protection of Human Subjects Training Certification

Experience with local and central IRB application processes

Motivated to help others

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

Work Schedule

This position will primarily support work M-F during normal business hours.

Underfill Statement

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

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 Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.