Clinical Research Technician jobs in United States
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Michigan Medicine · 8 hours ago

Clinical Research Technician

Michigan Medicine is one of the largest health care complexes in the world, and they are seeking a motivated and organized individual for a Clinical Research Technician role. This position involves supporting a study on inherited retinal diseases, managing day-to-day operations, and ensuring compliance with regulatory standards.

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Responsibilities

As an integral member of the research team, this position will help ensure that this study and others supported by the KCRC are initiated and executed in the highest quality and compliant manner
This position will play a pivotal role in maintaining day to day operations of this trial, including tasks related to subject recruitment, the administration of patient-reported outcome measures/instruments (PROs), and record keeping
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
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
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
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, assessing suicidality, and assisting participants with accessing online materials and questionnaires
Communication with participants will take place in person, over the phone and potentially through video conferencing mediums (i.e. Zoom)
Each study often has unique needs. The CRC is expected to possess a willingness to learn protocol specific requirements
Delegate tasks to full-time research interns, part-time temps, and undergraduate volunteers
Clinical research regulations and best practices are frequently changing. The CRC is expected to incorporate these changes into the workflow as they occur

Qualification

Clinical research experienceData entryOrganizationRegulationsREDCap experienceOphthalmic technician skillsEHR systemsExceptional organizational skillsWillingness to learnWork independentlyTeam collaborationCommunication skills

Required

Associate degree in Health Science or an equivalent combination of related education and experience
ONE of the following: Minimum 1 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying
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
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
Knowledge of general clinical research operations and regulations or a capacity to learn quickly
Ability to work both independently and as part of a team
Committed to prioritizing the welfare of the research volunteer
Exceptional organizational skills
Uncompromising integrity
Capacity to learn new skills as the positional needs change
Willingness to achieve professional certification such as SOCRA or equivalent
Experience with computers and applicable software (e.g. MS Word, Excel, Power Point, Outlook or equivalent)

Preferred

Bachelor's degree in Health Science or an equivalent combination of related education and experience
Experience working with patients in a healthcare setting and/or an understanding of medical terminology
Familiarity with terms related to psychology and/or an interest in research that involves psychological interventions
Ability to effectively communicate with staff and faculty of all levels
At least one year of directly related experience in clinical research and clinical trials
Knowledge of university policies and procedures
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 accommodate occasional patient needs for contact outside of typical working hours

Benefits

Excellent medical, dental and vision coverage effective on your very first day
2:1 Match on retirement savings

Company

Michigan Medicine

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Michigan Medicine is a health care system and academic medical center that provides medical education and more. It is a sub-organization of University of Maichigan.

Funding

Current Stage
Late Stage

Leadership Team

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Heather Ascani
Director, Business Operations - Applied Systems Biology Core
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Jack Kufahl
Chief Information Security Officer
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Company data provided by crunchbase