PED-COMPARATIVE EFFECTIVENESS (IN-PCER-IUINA)

For more than 90 years, the Department of Pediatrics at Indiana University School of Medicine has provided comprehensive medical training for medical students, residents and fellows in addition to lifelong learning opportunities for practicing physicians. The department consists of 19 specialty divisions based at Riley Hospital for Children at Indiana University Health, which is ranked as one of America's Best Children's Hospitals in 10 out of 10 specialties in US News and World Report.

Pediatric and Adolescent Comparative Effectiveness Research (PACER) in the Department of Pediatrics at IU School of Medicine is funded by a grant from the Agency for Healthcare Research and Quality in order to discover what matters most to children and caregivers with respect to health and to identify which treatments and therapies work best to deliver optimal outcomes. In partnership with the Children's Health Services Research group, PACER investigators host the annual Children's Health Services Research Symposium.

The goals of the Pediatric and Adolescent Comparative Effectiveness Research program are to: 1) Expand the research capacity of IU School of Medicine in pediatric subspecialties; 2) Establish a rigorous research program focused on patient-centered outcomes; 3) Build capacity and training for faculty to engage in comparative effectiveness research and patient centered outcomes research in pediatric subspecialties; and 4) Develop methods for incorporating findings into the larger health care system.

This Clinical Research Technician position will participate in health services research projects conducted within the Departments of Pediatrics and Obstetrics & Gynecology. This position will assist in the conduct of clinical studies and interventions that pertain to patient-provider communication and shared decision making in high-risk obstetrical and neonatal settings, especially in the context of periviable delivery (22-24 weeks gestation). Studies will likely be sensitive in nature and often require recruitment of potential subjects during emotionally heightened times.

Department-Specific Responsibilities

• Responsible for screening, identifying, approaching patients for eligibility, and recruiting participants into research studies.
• Approaches potential subjects in the clinical setting (e.g. Labor & Delivery Unit or outpatient clinics) about participating in research projects.
• Advertises research studies on social media platforms (e.g. Facebook, Twitter, Reddit, etc.) in compliance with institutional human subjects research policies. Recruits subjects from databases, social media, or in the clinical setting.
• Consents subjects in-person or virtually using HIPAA compliant video conferencing software (i.e. Zoom) into research projects. Ensures that Informed Consent forms are properly signed before the start of the study. Explains the purpose of the investigations and the requirements for participation in each study.
• Collects data from subjects, charts and interviews in adherence with the assigned study protocol and in accordance with good clinical principals.
• Conducts in-depth interviews at baseline and follow-up sessions. Coordinates, schedules, and conducts follow-up study procedures with participants.
• Responsible for entry and management of study-related data into electronic data capture systems.
• Performs coding of transcript data per instructions from PI.
• Tracks recruitment and keeps accurate records on respondent and non-respondent characteristics.
• Suggests strategies for improving recruitment and for data management.
• Communicates with the PI and Research Coordinator and provides assistance with additional research projects and tasks as needed.

General Responsibilities

• Assists in the conduct of clinical research studies or trials following established protocols and standard operating procedures.
• Assists with identifying and recruiting subjects for clinical research studies or trials; calls/schedules subjects for appointments per protocol.
• Performs screening, consenting and interviewing/data collection in adherence with the assigned study protocol and in accordance with good clinical principals.
• Collects patient consent and authorization for treatment intervention documents and performs those interventions as needed.
• Conducts routine experiments and/or coordinates research study procedures in accordance with SOPs; receives, collects, and records study data in database; communicates and keeps researchers and/or PI up-to-date on any problems or concerns related to the research study or trial; may be responsible for collecting clinical samples (such as blood, sample tissue, etc.) for research including any storage measures.
• Assists with advertising and other information for participant recruitment; assists in developing and sharing educational and informational resources with subjects and families.
• Ensures proper documentation of Case Report Forms, regulatory documents, PI notes, and any other mandatory study-related documents and ensures quality and accuracy; archives documents for study per sponsor, government and institutional requirements; keeps accurate records and provides necessary documents for regulatory audits.
• Maintains and manages inventory and research study supplies; may be responsible for facilitating disbursement of study participant payments.
• Provides various additional research study support (such as protocol research in medical library/online databases, summarizing literature reviews for study hypothesis, grant preparation, manuscript review/editing, literature searches, and/or transcription).
• Stays up-to-date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings.

EDUCATION / WORK EXPERIENCE

Required

• Bachelor's degree in science or health-related field OR
• Associate degree in allied health profession plus 1 year of patient-related or research experience OR
• Bachelor's degree in any field OR 3 years of college-level science plus 2 years patient-related or research experience OR
• High school diploma or GED plus 5 years patient-related or research experience that includes 2 years of experience with clinical studies

Combinations of related education and experience may be considered

SKILLS

Required

• 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

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.

Indianapolis, Indiana

Career Level: Intermediate

FLSA: Nonexempt

Job Function: Research

Job Family: Clinical Research

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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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