Clinical Research Specialist

318941 Department CANCER CENTER (IN-CANC-IUINA) Department Information The Indiana University (IU) Simon Comprehensive Cancer Center (SCCC) is 1 of only 57 National Cancer Institute (NCI)-designated Comprehensive Cancer Centers in the United States. This prestigious 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 to prevention, diagnosis, and treatment of cancer. The Biospecimen Collection and Banking Core supports cancer research by providing comprehensive biospecimen management including collection, storage, distribution, and annotation. Job Summary 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 tests, 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 experience clinical research staff. Qualifications Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education. EDUCATION / WORK EXPERIENCE Required 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 Required Proficient 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. 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. Work Location IU Indianapolis Campus Benefits Overview For full-time staff employees, Indiana University offers a wide array of benefits including: 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 . Job Classification Career Level: Mastery FLSA: Nonexempt Job Function: Research Job Family: Clinical Research Click here to learn more about Indiana University's Job Framework. Equal Employment Opportunity 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 . Contact Us Request Support Telephone: ...