Job Information
University of Michigan Clinical Research Technician in Ann Arbor, Michigan
Clinical Research Technician
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Summary
The University of Michigan Kellogg Clinical Research Center (KCRC) is seeking a motivated and organized individual for an enriching work experience at Kellogg Eye Center supporting an investigator-initiated study. The ideal candidate will have a desire to gain expertise in both psychology and ophthalmology aspects of the project and a willingness to learn skills to extend to new projects as they come. This would be an excellent project on which to gain experience and build a career; the department?s research compliance specialist will provide oversight and support for this role while increasing independence is gained.
Dr. Jayasundera, a retinal surgeon and inherited retinal diseases specialist, along with Dr. Fresco, a distinguished professor of psychiatry, have a comprehensive National Institutes of Health (NIH)-funded project that aims to address various conditions associated with inherited retinal diseases. These conditions often lead to distress, depression, and a spectrum of vision-related disabilities. Their unique intervention approach combines low vision rehabilitation and psychotherapy to alleviate distress and improve overall well-being.
As an integral member of the research team, the Clinical Research Coordinator (CRC) will help ensure that this study and others supported by the KCRC are initiated and executed in the highest quality and compliant manner. The CRC will play a pivotal role in setting up this clinical trial, including tasks related to subject recruitment and the administration of patient-reported outcome measures/instruments (PROs).
In order to succeed, the applicant must possess exceptional communication and organizational skills, uncompromising integrity, a love of people, and a strong willingness to learn new skills. If you are passionate about making a difference in the field of retinal diseases, possess strong interpersonal skills, and are eager to contribute to the development of interventions that address both medical and psychosocial aspects, we encourage you to apply.
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*
COMMUNICATIONS: The CRC is expected to facilitate communications between team members, investigators, regulatory personnel, and other key contributors both in written and spoken form, using various software to document decision-making as needed. They will relay study details to potential and enrolled participants, create written materials (e.g. letters, flyers, and consent documents), and assist with submissions and reports as required by the IRB, NIH, and other stakeholders. They will also communicate with sponsors, the University of Michigan Clinical Trials Support Unit (CTSU), and contract research organizations as applicable. The communications will include, but are not limited to scheduling participants appointments, meeting with investigators, interfacing with the regulatory and financial authorities, working closely with study monitors, and resolving issues that invariably arise.
DATA: The CRC will be involved in data entry and organization, tracking screening, recruitment, randomization, and completion of participant activities, inputting data into REDCap, Excel, and case report forms (CRFs), maintaining studies in the OnCore clinical trial management system, and resolving queries.
REGULATORY COMPLIANCE: Employees of the KCRC follow all local, state, and federal regulations regarding clinical research in addition to Good Clinical Practice and protocol specific guidelines. The CRC is expected to actively support an environment of strict regulatory compliance. The CRC will work within UM's eResearch regulatory system to create and revise IRB submissions, track any protocol deviations or adverse events and assure they are reported in a timely manner, and organize and store regulatory documents required by the NIH, UM, the Food and Drug Administration (FDA) and other regulatory authorities as required.
RECRUITMENT AND PARTICIPANT INTERACTION: The CRC will recruit and guide participants through study activities, including scheduling appointments with low vision and psychotherapy providers on the study team, conducting surveys, and assisting participants with accessing online materials and questionnaires. Communication with participants will take place in person, over the phone and through video conferencing mediums (i.e. Zoom).
PROTOCOL SPECIFIC NEEDS: Each study often has unique needs. The CRC is expected to possess a willingness to learn protocol specific requirements.
OTHER: Clinical research regulations and best practices are frequently changing. The CRC is expected to incorporate these changes into the workflow as they occur.
Required Qualifications*
Clinical Research Coordinator Technician
Associate degree in Health Science or an equivalent combination of related education and experience is necessary.
ONE of the following:
Minimum 1 year of directly related experience in clinical research and clinical trials. (Please review SoCRA'sDefinition of a Clinical Research Professional (https://www.socra.org/certification/certification-program/definition-of-a-clinical-research-professional/for) qualifying experience prior to applying.)
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.
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 Coordinator Assistant
- High School Diploma or GED
All Titles:
Knowledge of general clinical research operations and regulations or a capacity to learn quickly
Willingness to achieve professional certification such as SOCRA or equivalent
Committed to prioritizing the welfare of the research volunteer
Exceptional organizational skills
Uncompromising integrity
Capacity to learn new skills as the positional needs change
Ability to work both independently and as part of a team
Experience with computer keyboards and applicable software (e.g. MS Word, Excel, Power Point, Outlook or equivalent)
Desired Qualifications*
Bachelor's degree in Health Science or an equivalent combination of related education and experience
Experience working with patients in a healthcare setting
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
At least one year of directly related experience in clinical research and clinical trials
Experience with the MiChart (Epic) electronic health record (EHR) system
Experience with REDCap databases
Experience with the OnCore clinical trial management system (CTMS)
Ophthalmic technician skills (e.g. visual acuity, refraction, intraocular pressure, etc.) and phlebotomy skills or a willingness to learn as they may be needed in future studies.
Willingness to adjust schedule to accommodate occasional patient needs for contact
Underfill Statement
This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.
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
249347
Working Title
Clinical Research Technician
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 Ophthal. & Visual Science
Posting Begin/End Date
5/20/2024 - 6/03/2024
Career Interest
Research
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