Clinical Research Coord Assoc/Tech/Asst

4 weeks ago

Ann Arbor, United States University of Michigan Full time

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 . Michigan Medicine is comprised of over 30, 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*

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.

Knowledge of all 8 competency domains is expected and experience within applicable domains specific to unit needs.

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
 

The clinical research coordinator is responsible for all aspects of study administration including but not limited to the following:

Regulatory maintenance (prepares, maintains, and manages regulatory applications and submissions; maintains study binder and records, manages study communications and follow-up including query resolution in a timely manner) Conducts necessary procedures for study closeouts Creation of research documents, presentations, and educational materials for patients, staff, and faculty Screening for potential research participants in both inpatient and outpatient settings Explaining research studies to potential subjects and their parents and obtaining informed consent and assent  Entering subject study enrollment as required by Michigan Medicine Placing research orders in Michart  Scheduling and coordinating research visits Coordinating with the Data Office for electronic medical record data capture.  Data collection and entry into electronic data capture systems (e.g. REDCap, DrugDEV) Reliable tracking of subjects to ensure subject retention necessary for high follow up rate  Demonstrates ability to identify Adverse Events, Serious Adverse Events, and ORIOs and to report these appropriately Financial tracking of patient visits to ensure proper billing for research subjects, as well as processing subject incentives through HSIP Compliance with protocols, Good Clinical Practice, and applicable federal, state, & institutional regulations  Takes an active role in data quality by completing data queries

Required Qualifications*

Clinical Research Coordinator Associate:

Bachelor?s degree in Health Science or an equivalent combination of related education and experience is necessary. Certification is required through Association of Clinical Research Professionals (register or take the exam at date of hire and the certification must be completed or passed etc . within six months of date of hire. (Please review eligibility criteria from orprior to applying.) Minimum 2 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA?sfor qualifying experience prior to applying.)

Clinical Research Technician:

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 SoCRA?s 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.

Clinical Research Assistant:

High school diploma or GED is necessary.

Desired Qualifications*

Clinical Research Coordinator Associate:

4+ years of direct related experience

Clinical Research Technician:

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. 

Clinical Research Assistant:

Associate 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. 

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Work Locations

This position may be eligible for remote and/or flexible work opportunities at the discretion of the hiring department. Flexible work agreements are reviewed annually and are subject to change dependent on the business needs of the hiring department, throughout the course of employment.

Underfill Statement

This position may be underfilled at the CRC-Technician or CRC-Assistant titles based on selected candidates? qualifications.

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