The Division of Pediatric Gastroenterology, Hepatology and Nutrition at IU School of Medicine includes 17 board-certified pediatric gastroenterologists, one nurse practitioner, one general pediatrician and one psychologist who care for children with disorders of the digestive tract: esophagus, stomach, intestine, liver and pancreas. Pediatric gastroenterologists provide comprehensive evaluations and individualized treatment plans for patients and extensive education for families.
The IUSM Department of Pediatrics Division of Pediatrics Gastroenterology is seeking a Clinical Research Specialist.
Primary Responsibilities Include:
Assists in the conduct and implementation of clinical research studies or trials. Assists in 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. Records study data, samples, and/or results in various databases; maintains databases for subjects and subject scheduling; provides reporting on study data as requested.
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.
Must meet one of the following qualifications:
Bachelor's degree in science or a health-related field and one year of health-related or research experience OR
Associate's degree in an allied health profession and three years of health-related or research experience.
Combinations of related education and experience may be considered.
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 / 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.
Career Level Competencies:
Self-Development (Mastery): Actively seeking new ways to grow and be challenged using both formal and informal development channels.
Resourcefulness (Mastery): Securing and deploying resources effectively and efficiently.
Career Level Dimensions:
Functional Knowledge Requires advanced working knowledge and/or understanding of a technical or specialty area. Requires proficiency in performing assigned tasks/responsibilities. Requires the ability to identify and improve processes for completing assigned duties. Requires the ability to readily learn and apply new information/concepts.
Problem Solving and Complexity Requires low degree of direct supervision and oversight. Often responsible for coordinating small projects/programs/teams with limited authority to deviate from established processes/procedures.
Autonomy and Decision-Making Requires ability to troubleshoot and/or solve complex issues and problems by applying advanced skills and knowledge. Often requires understanding and application of complex laws, regulations, or technical procedures.
Scope and Impact Duties and responsibilities are typically focused and/or modest, but could be multi-departmental.
Leadership and Influence May lead or oversee hourly staff or lower-level appointed staff. No hiring or firing authority.
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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Beginning with the fall 2021 semester, all Indiana University students, faculty, and staff will be required to be fully vaccinated for COVID-19 as a condition of enrollment / employment.To learn more about this requirement, view ourCOVID-19 vaccine information page .
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About Indiana University Purdue University Indianpolis - IUPUI
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.