Clinical Research Coordinator, Pediatric Pulmonology, Allergy, and Sleep Medicine

Responsibilities

• Participant recruitment, informed consent, study visit coordination
• Data collection, regulatory documentation
• Communication with investigators, sponsors, and clinical teams

Department-Specific Responsibilities

• Oversees study coordination and execution
• Conducts participant recruitment, screening, and informed consent
• Facilitates study visits, assessments, participant follow-up, specimen collection, processing, management, and shipping
• Oversees regulatory compliance, protocol adherence, and institutional requirements
• Facilitates communication and liaison activities

General Responsibilities

• Initiates and conducts protocol review, evaluations, study design, and risk assessments
• Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks
• Coordinates screening, consenting, and scheduling of tests, exams, and/or non-medical/behavioral interventions and assessments involving study subjects
• 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 Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary); prepares regulatory documents for sponsor
• 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

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

Skills

• Demonstrates analytical skills
• Possesses strong technical aptitude
• Demonstrates a high commitment to quality
• Excellent organizational skills

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

Pay

$50,000.00 - 60,000.00 per year based on a combination of experience, skill level, education, and training

Schedule

Not specified