Clinical Research Specialist

Overview CANCER CENTER (IN-CANC-IUINA) The mission of the Indiana University (IU) Simon Comprehensive Cancer Center (IUSCCC) Clinical Trials Office (CTO) is to support and facilitate the conduct of quality clinical research by IUSCCC translational clinical investigators. The CTO is a centralized resource available to all clinical investigators of the IUSCCC whose services enable the safe and efficient conduct of adult and pediatric trials. The CTO provides a comprehensive range of services. These services begin in the early stages of protocol development and continue throughout the study implementation, publication and long-term follow-up. Responsibilities Assists with identifying and recruiting potential research study subjects; determines eligibility according to the Institutional Review Board (IRB) / protocol approved methodologies, coordinates study procedures, and monitors the progress of research studies or projects. 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 principal investigator (PI), sub-investigators, and/or other study stakeholders. Monitors study team compliance with protocol and standard operating procedures (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 experienced clinical research staff. Qualifications 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 experience. Skills Proficient in English written and verbal communication skills. Maintains a high degree of professionalism. Demonstrates 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. 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. Location IUSCCC Clinical Trials Office IU Indianapolis Indianapolis, Indiana Benefits Comprehensive medical and dental insurance Health savings account with generous IU contributions Healthcare and dependent care flexible spending accounts Basic group life insurance paid by IU Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death & dismemberment insurance Base retirement plan with generous IU contributions, subject to vesting Voluntary supplemental retirement plan options Tuition subsidy for employees and family members taking IU courses 10 paid holidays plus a paid winter break each year Generous paid time off plans Paid leave for new parents and IU-sponsored volunteer events Employee assistance program (EAP) Learn more about our benefits by reviewing the IU Benefit Programs Brochure. Career Level: Mastery FLSA: Nonexempt Job Function: Research Job Family: Clinical Research Click here to learn more about Indiana University's Job Framework. 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. Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information. The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online. 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