Clinical Research Coordinator

Company: Indiana University
Location: Bloomington
Posted on: May 28, 2023

Job Description:

The I-CARE 2 study is a randomized clinical trial that tests how telehealth technology can positively affect informal caregivers and patients living with Alzheimer's disease and related dementias. The project will gather data over time to measure the impact of our evidence-based Brain CareNotes mobile telehealth app on informal caregiver burden and patients' behavioral and psychological symptoms of dementia, in a diverse Indiana-wide sample. Under the direction of Dr. Richard Holden, the study has a joint presence in Bloomington, Indianapolis, and online. Research for the study is highly interdisciplinary, applying expertise from social and behavioral sciences, systems engineering and informatics, human-centered design and evaluation, and the health professions. Topics addressed include medication safety; mobile health, sensors, and other technology; healthy aging and disease prevention; family caregiving for people with dementia; participatory design of interventions; and social determinants of health and healthy equity. The research lab pursues better health, by design through the development and testing of sociotechnical interventions in key areas of prevention and care.

The lab offers its team members skills development, professional advancement, and competitive funding.

Dr. Holden is Professor and Chair of Health & Wellness Design at Indiana University School of Public Health-Bloomington. He is a Jack A. Kraft Innovator, Regenstrief Venture Fellow, CHIIS's Chief Healthcare Engineer, and Dean's Eminent Scholar ... but most of all, he is a dedicated mentor. Those working in his labs are eligible for mentorship and project opportunities from a network of over a dozen faculty in and outside the Department of Health & Wellness Design and the Indiana University School of Public Health-Bloomington. Health & Wellness Design is an academic department with 20 full-time faculty, over 400 students enrolled in BS, MS, MPH, and PhD programs, and closely connected to Indiana University and Purdue University schools of Medicine, Dentistry, Nursing, Pharmacy, Engineering, Informatics, Art & Design, Public and Environmental Affairs, and Public Health as well as other state entities including Regenstrief Institute, Inc., the Indiana Clinical and Translational Sciences Institute, IU Health and Eskenazi Health.

More information about the Department of Health & Wellness Design in the School of Public Health-Bloomington at Indiana University may be found here.

Job Summary

• Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies.
• Participates in study budget negotiations and reconciles study budget accounts.
• Develops informational materials for recruitment of subjects; monitors enrollment goals and modifies recruitment strategy as needed.
• Oversees and ensures compliance with regulations, including organizing electronic files and/or filing regulatory documents appropriately; prepares and submits Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary); prepares regulatory documents for sponsor.
• Identifies and selects potential subjects by reviewing existing protected health information, screening subjects, and conducting interviews; performs subject interviews and assessments for data required by protocol(s).
• Follows up on study documentation with necessary stakeholders (healthcare providers, study participants, laboratory personnel, etc.)
• Reviews incoming subject adverse event (SAE) information, assists PI in making submission determination of SAEs, and follows up to determine resolution of adverse events.
• Conducts study-related non-medical/behavioral assessments/interventions as well as study procedures/interventions (appropriate licensure may apply).
• Records, documents, and reports protocol deviations and trial changes to PI and sub-investigators.
• Stays up to date with knowledge of regulatory affairs and/or issues. Qualifications
  
  EDUCATION / WORK EXPERIENCE
  
  Required
  • Bachelor's degree in science or a health-related field and 2 years of clinical research experience OR
  • Associate's degree in science or a health-related field and 3 years of clinical research experience Combinations of related education and experience may be considered
    
    LICENSES AND CERTIFICATES
    
    Preferred
    • SOCRA/ARCP Clinical Research Certification upon date of hire SKILLS
      
      Required
      • Demonstrates analytical skills
      • Ability to simultaneously handle multiple priorities
      • Possesses strong technical aptitude
      • Demonstrates a high commitment to quality
      • Excellent organizational skills Working Conditions / Demands
        
        The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. The person in this role must be able to perform the essential functions with or without an accommodation.
        
        Additional Information
        
        This position is grant funded with expected annual renewals. Renewals are contingent on the availability of grant funds.
        
        Job Classification
        
        Career Level: Career
        
        FLSA: Exempt
        
        Job Function: Research
        
        Job Family: Clinical Research
        
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        Due to the COVID-19 pandemic, there may be differences in the working conditions as advertised in our standard job postings (e.g., the ability to travel from one campus to another, etc.). If you are invited for an interview, please discuss your questions or concerns regarding the working conditions at that time.
        
        This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
        
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        Indiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment based on individual qualifications. Indiana University prohibits discrimination based on age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University's Notice of Non-Discrimination here which includes contact information .
        
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Keywords: Indiana University, Bloomington , Clinical Research Coordinator, Healthcare , Bloomington, Indiana