Clinical Research Coordinator, Pediatrics Health Services Research

Indiana University is an institution whose Department of Pediatrics supports pediatric healthcare and research in collaboration with Riley Hospital for Children and Indiana University School of Medicine. The Clinical Research Coordinator will lead operations for a multisite pediatric kidney transplant research study, coordinating regulatory activities, data collection, participating sites, compliance, and research personnel. The role also supports clinical research study design, recruitment, subject assessments, documentation, and regulatory reporting.

Responsibilities

• Leads day-to-day operations of a complex, multisite pediatric kidney transplant research study across five high-volume pediatric transplant centers
• Serves as the primary operational contact for participating sites and coordinates activities among investigators, research personnel, regulatory offices, data teams, and Dr. Laster
• Coordinates retrospective and prospective data collection for pediatric patients with end-stage kidney disease (ESKD), including kidney transplant referral, evaluation, waitlisting, and priority listing data
• Leads regulatory start-up and ongoing activities across five participating institutions, including institutional review board (IRB) submissions, amendments, continuing reviews, reliance processes, and study closeout
• Coordinates data use agreements and other institutional agreements with university offices and participating sites
• Maintains regulatory documentation, study records, data dictionaries, and tracking systems
• Exercises independent judgment in monitoring study compliance, documentation, and data quality
• Identifies and resolves protocol and operational issues in collaboration with investigators, sponsors, and regulatory personnel
• Reviews adverse event documentation assists with reportability determinations, and tracks corrective and preventive actions
• Evaluates protocols for operational feasibility, identifies implementation challenges, and develops strategies to support successful study execution
• Contributes to protocol development, study planning, workflow design, and quality improvement initiatives
• Supports onboarding, training, and mentorship of research personnel at the coordinating center and participating sites
• Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies
• Participates in study budget negotiations and reconciles study budget accounts
• Develops informational materials for recruitment of subjects. Monitors enrollment goals and modifies recruitment strategy as needed
• Oversees and ensures compliance with regulations, including organizing electronic files and/or filing regulatory documents appropriately. Prepares and submits IRB documents (i.e., Informed Consent, advertisement, protocol and protocol summary). Prepares regulatory documents for sponsor
• Identifies and selects potential subjects by reviewing existing protected health information, screening subjects, and conducting interviews. Performs subject interviews and assessments for data required by protocol(s)
• Follows up on study documentation with necessary stakeholders (healthcare providers, study participants, laboratory personnel, etc.)
• Reviews incoming subject adverse event (SAE) information, assists Principal Investigator (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
• Stays up to date with knowledge of regulatory affairs and/or issues

Preferred

• Society of Clinical Research Associates (SOCRA) / Association of Clinical Research Professionals (ACRP) clinical research certification upon date of hire
• SOCRA certification
• ACRP certification
• Clinical research

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)

Company

• University with nine campuses and online degree programs
• Bloomington, Indiana, USA
• https://www.iu.edu/
• Founded in 1820
• 10001+ employees

Qualifications

• Bachelor's degree in science or a health-related field and 2 years of clinical research experience; OR
• Associate's degree in science or a health-related field and 3 years of clinical research experience
• Demonstrates analytical skills
• Ability to simultaneously handle multiple priorities
• Possesses strong technical aptitude
• Demonstrates a high commitment to quality
• Excellent organizational skills
• 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
• This position is not eligible for visa sponsorship
• Society of Clinical Research Associates (SOCRA) / Association of Clinical Research Professionals (ACRP) clinical research certification upon date of hire
• Associate's degree in science or a health-related field and 3 years of clinical research experience.

Required skills

• , SOCRA/ACRP Clinical Research Certification

Experience

• 2+ years