Clinical Research Coordinator, Pediatrics Children's Health Services Research jobs in United States
Indiana University
Responsibilities
- Leads day-to-day operational activities for complex, multisite pediatric oncology research studies across participating pediatric centers
- Serves as the primary operational contact for participating sites and coordinates activities among investigators, research personnel, regulatory offices, and data teams
- Coordinates retrospective and prospective data collection for pediatric oncology patients, including patients with established care plans
- Oversees standardized data collection, tracking, and quality control processes to ensure accurate and complete study data
- Manages participant recruitment, screening, consent, scheduling, study procedures, data collection, and follow-up
- Provides guidance to research personnel regarding study procedures, documentation requirements, study timelines, and protocol implementation
- Leads day-to-day operational activities for pediatric behavioral research studies focused on eating disorders, weight stigma, nutrition, physical activity, and weight-related health outcomes
- Coordinates research activities across participating pediatric centers and serves as a primary operational contact for investigators, research personnel, regulatory offices, and data teams
- Monitors study data to identify patient-, interpersonal-, neighborhood-, and health system-level factors associated with disordered eating and other weight-related health concerns
- Oversees standardized data collection, tracking, and quality control processes
- Provides guidance to research personnel regarding study procedures, documentation, timelines, and protocol implementation
- 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
- Monitors regulatory and contractual requirements, identifies barriers to site activation, and works with stakeholders to resolve issues
- Ensures ongoing compliance with federal, institutional, sponsor, and protocol requirements
- Collaborates with investigators, transplant centers, research staff, data teams, and other stakeholders to ensure timely completion
- 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 risks related to participant safety, data integrity, compliance, and study timelines and escalates significant concerns as needed
- Monitors study milestones, data submissions, participation, and site deliverables
- Conducts data quality checks and works with sites to resolve discrepancies
- 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
- Develops standardized processes, tools, and workflows to promote consistency and continuous improvement across multisite research operations
- Provides ongoing training, coaching, and development to the Research Technician and helps establish consistent research practices across assigned projects
- Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies. Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks
- Conducts study visit activities and coordinates screening, consenting, and scheduling of tests, exams, and/or non-medical/behavioral interventions and assessments involving study subjects
- Facilitates and performs various study activities including site evaluation visits, study related meetings and training sessions, study initiation visits (SIV) and monitoring visits
- Manages all 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
- Develops informational materials for recruitment of subjects; monitors enrollment goals and modifies recruitment strategy as needed
- 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
Preferred
- Society of Clinical Research Associates (SOCRA) / Association of Clinical Research Professionals (ACRP) clinical research certification upon date of hire
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)
- Glassdoor
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- Bloomington, Indiana, USA
- https://www.iu.edu
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Qualifications
- Bachelor's degree in science or a health-related field and 1 year of clinical research experience; **OR**
- Associate's degree in science or a health-related field and 2 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
- 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 2 years of clinical research experience.
Required skills
- ACRP Clinical Research Certification, SOCRA Clinical Research Certification
Experience
