Clinical Research Technician, Pediatric Health Services Research

Department of Pediatrics Health Services Research is seeking a Clinical Research Technician to support clinical research studies within Indiana University School of Medicine and Riley Hospital for Children.

About the Role

The Division of Pediatrics Health Services Research conducts and manages clinical research studies, ensuring compliance with protocols, regulatory standards, and best practices in pediatric health services research.

Responsibilities

• Conducts and completes clinical research studies, including protocol review, evaluations, study design, and risk assessments.
• Identifies and selects research study subjects by reviewing protected health information, screening, and conducting interviews; performs subject interviews and assessments for data required by protocol(s).
• Performs data management and informatics related to clinical research studies.
• Ensures compliance with protocol, regulatory requirements, standard operating procedures (SOPs), and Good Clinical Practices (GCP).
• Develops solutions to problems impacting the timeliness and accuracy of clinical research studies.
• Conducts study visit activities, including coordinating screening, consenting, scheduling tests, exams, and non-medical/behavioral interventions and assessments.
• Manages follow-up activities with subjects based on protocols and oversees proper documentation at study close-out.
• Participates in study budget negotiations and reconciles study budget accounts.
• Follows up on study documentation with stakeholders (healthcare providers, study participants, laboratory personnel, etc.).
• Reviews incoming subject adverse event (SAE) information, assists the principal investigator (PI) in submission determinations, and follows up to resolve adverse events.
• Assists in the conduct of clinical research studies or trials following established protocols and SOPs.
• Assists with identifying, recruiting, and scheduling subjects for clinical research studies; performs screening, consenting, and data collection in adherence to study protocols.
• Conducts routine experiments and coordinates research study procedures; collects and records study data in databases; communicates issues to researchers or PI.
• May collect clinical samples (e.g., blood, tissue) for research, including storage measures.
• Assists with participant recruitment, including advertising and developing educational resources for subjects and families.
• Ensures proper documentation of Case Report Forms, regulatory documents, PI notes, and other study-related materials; archives documents per sponsor, government, and institutional requirements.
• Maintains and manages inventory of research study supplies; may facilitate disbursement of study participant payments.
• Provides additional research study support, such as protocol research, literature reviews, grant preparation, manuscript review/editing, literature searches, and transcription.
• Stays up-to-date on regulatory affairs and clinical research best practices through continuing education, conferences, seminars, and project team meetings.

Requirements

• High school diploma or equivalent (e.g., HSED or GED) plus 5 years of patient-related or research experience, including 2 years of experience with clinical studies; OR
• Associate's degree in an 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 of patient-related or research experience; OR
• Bachelor's degree in science or a health-related field.

Skills

• Proficient written and verbal communication skills.
• High degree of professionalism, thoroughness, and dependability.
• Strong time management and priority-setting skills.
• Commitment to quality and flexibility to work in a fast-paced, dynamic environment.
• Ability to move about the work environment, operate laboratory equipment, and move objects weighing up to 25 pounds.
• Occasional work near moving mechanical parts.
• Ability to perform essential functions with or without accommodation.

Pay

$40,000.00 - $45,000.00 annually, determined by education, experience, knowledge, skills, and abilities, as well as internal equity and market data.

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.
• Generous paid time off plans.
• Paid leave for new parents and IU-sponsored volunteer events.
• Employee assistance program (EAP).