The Indiana University School of Medicine Department of Otolaryngology--Head and Neck Surgery, established in 1909, has a proud tradition of achievement in the areas of medical research, education and patient care. The faculty of this department treat diseases of the ear, nose and throat; research innovative new treatments; and educate the next generation of otolaryngology--head and neck surgeons.
Our researchers contribute regularly to the creation of new knowledge, understanding and treatments surrounding diseases of the ear, nose and throat. Faculty members in this department study various challenges in this area of medicine, such as understanding how hearing loss affects a child's developing brain, or how cachexia or unintentional weight loss affects cancer patients.
An area of research affecting both adults and children, otolaryngology provides wide and varied research interests. Scientists in this department are currently researching regenerative medicine, cancer cachexia, cerebrospinal fluid (CSF) leaks, inner ear disorders, neurofibromatosis, pediatric airway abnormalities, pediatric cochlear implants, and peripheral nerve regeneration.
The Clinical Research Coordinator assists in the conduct of clinical trials and research involving human subjects. This position performs varied routine and non-routine tasks of moderate complexity. As a Clinical Research Coordinator this position initiates, conducts, completes, and reports clinical studies. This position also assigns and coordinates activities of study sites to ensure protocol, regulatory, and standard operating procedures and Good Clinical Practices compliance. Incumbents in this position must be able to develop solutions to complex problems that impact the timeliness and accuracy of the conduct of our clinical research.
Duties and Responsibilities:
Participates in protocol review, evaluations, study design, and risk assessments to subject population.
Participates in study budget negotiations and reconciles study budget accounts with the business manager.
Develops informational materials for recruitment of subjects.
Organizes, manages, and distributes regulatory documents.
Identifies potential subjects by reviewing existing protected health information, screens subjects, and conducts interviews.
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.
Maintains current knowledge of regulatory affairs and/or issues.
Bachelor's degree in science or a health-related field and two years of clinical research experience; OR associate's degree in science or a health-related field and three years of clinical research experience.
Combination of education and related experience may be considered.
Clinical Research Certification (ARCP or SOCRA).
Analytical skills and ability to simultaneously handle multiple priorities. Strong technical aptitude and ability to demonstrate a high commitment to quality. Excellent organizational skills. Ability to identify and resolve less complex problems/issues/ assignments. Problem-solving skills. Ability to determine if/when it is appropriate to seek additional guidance/assistance (escalation). Often sets priorities and/or sequence of tasks to achieve objectives with oversight.
Working Conditions / Demands
Clinical setting and patient facing. General movement around the building and visiting patients. Ability to remain stationary at a computer for long stretches of time. Ability to communicate effectively.
Must be able to perform the essential functions of the position with or without reasonable accommodation.
Salary Plan: PAE
Salary Grade: 3RS
Job Function: Research
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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Founded in 1820, Indiana University is the state’s public university system, comprised of two core campuses—IU-Bloomington and IUPUI—and six regional campuses located throughout the state. Combined, the total student population is more than 114,000 undergraduate, graduate and professional school students. IU is one of the largest employers in the state, with over 20,000 faculty and staff. Indiana University is an equal employment and affirmative action employer and a provider of ADA services. Diversity and inclusion remains a core commitment to IU’s mission to cultivate an educational environment that supports equal access, participation and representation on all of its campuses and that provides educational and career opportunities for all.