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Clinical Research Specialist

Company: Indiana University
Location: Indianapolis
Posted on: January 17, 2022

Job Description:

DepartmentCANCER CENTER (IN-CANC-IUINA)Department InformationThe IU Simon Comprehensive Cancer Center (IUSCCC) is the only National Cancer Institute (NCI)-designated comprehensive cancer center in the state of Indiana. This designation recognizes centers around the country that meet rigorous criteria for world-class, state-of-the-art programs in multidisciplinary research. The IUSCCC puts significant resources into developing research programs, faculty and facilities that will lead to better approaches for prevention, diagnosis and treatment of cancer.Job SummaryThe IU Simon Comprehensive Cancer Center is seeking a Clinical Research Specialist for the Data and Regulatory team in the Biospecimen Collection and Banking Core (BC2). This core supports cancer research by providing comprehensive biospecimen management including collection, storage, distribution and annotation. Primary duties performed by the Clinical Research Specialist include the following:

  • Assists with identifying and recruiting potential research study subjects; determines eligibility according to the IRB/protocol approved methodologies, coordinates study procedures, and monitors the progress of research studies or projects.
  • Shares treatment and intervention alternatives, provides information, and ensures that Informed Consent forms are executed by study participants and documented properly before the start of the study.
  • Conducts study visit activities and coordinates screening, consenting, and scheduling of test, exams, and/or non-medical/behavioral interventions and assessments involving study subjects; coordinates, facilitates, and performs various study activities; manages all follow-up activities with subjects based on protocols.
  • Records study data, samples, and/or results in various databases; maintains databases for subjects and subject scheduling; performs data validation checks and pursues resolutions to erroneous data; produces various reports in response to requests from PI, sub-investigators, and/or other study stakeholders.
  • Monitors study team compliance with protocol and SOPs; submits all regulatory paperwork required; communicates with PI and sub-investigators about concerns or recommended changes in study protocols, etc.
  • Assists with developing various communications and strategies for advertising and recruitment, as well as in developing information materials for study participants.
  • Stays up-to-date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings.
  • Provides various other clinical research study or project support as needed (such as assisting with budget development, invoicing for adverse events, billing compliance and patient billing resolution).
  • May provide guidance and/or support to less experience clinical research staff. QualificationsEDUCATION / WORK EXPERIENCERequired
    • Bachelor's degree in science or a health-related field and 1 year of health-related or research experience OR
    • Associate's degree in an allied health profession and 3 years of health-related or research experienceCombinations of related education and experience may be considered.SKILLS
      • Proficient communication skills
      • Maintains a high degree of professionalism
      • Demonstrated time management and priority setting skills
      • Demonstrates a high commitment to quality
      • Possesses flexibility to work in a fast paced, dynamic environment
      • Highly thorough and dependable
      • Possesses a high degree of initiative
      • Ability to build strong customer relationships Working Conditions / DemandsThe 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.Job ClassificationCareer Level: MasteryFLSA: NonexemptJob Function: ResearchJob Family: Clinical ResearchClick here to learn more about Indiana University's Job Framework.Posting DisclaimerDue 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.If you wish to include a cover letter, you may include it with your resume when uploading attachments.New employees will be provided with information regarding Indiana University's COVID-19 vaccine policy, which includes the opportunity to request an exemption. To learn more, view our COVID-19 vaccine information page.Equal Employment OpportunityIndiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment without regard to 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.Campus Safety and SecurityThe Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online. You may also request a physical copy by emailing IU Public Safety at iups@iu.edu or by visiting IUPD.Contact UsRequest SupportTelephone: 812-856-1234

Keywords: Indiana University, Indianapolis , Clinical Research Specialist, Healthcare , Indianapolis, Indiana

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