Clinical Research Specialist, Pediatric Nephrology

About the role

The Department of Pediatrics employs nearly 1,000 faculty and staff who work alongside employees of Riley Hospital for Children and students of Indiana University (IU) School of Medicine (IUSM) to make Riley Children's Health Indiana's largest and most skilled pediatric system. At IUSM, our mission and core values define who we are, how we act, and what we aspire to accomplish. The Clinical Research Specialist supports pediatric Nephrology transplant programs in the coordination, tracking, and integrity of clinical and research data related to kidney transplant patients. This position involves managing complex datasets across pre- and post transplant phases, including patient demographics, clinical outcomes, laboratory values, immunosuppression protocols, and regulatory reporting requirements. The specialist collaborates closely with physicians, research staff, and multidisciplinary teams to ensure timely and accurate data entry into institutional databases, sponsor systems, and national registries. Indianapolis, Indiana

Responsibilities

Department-Specific Responsibilities

• Submits studies to institutional review board (IRB) and consent research participants.
• Prepares data for analysis
• Supports grant and regulatory submissions
• Conducts research visits/consenting while maintaining compliance with IRB and Health Insurance Portability and Accountability Act (HIPAA) standards
• Assists with quality assurance audits

General Responsibilities

• 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
• 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 experience clinical research staff

Requirements

Education and Experience

• 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

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.

Skills

• Proficient 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

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