Adverse Events, Allergies, Analysis Skills, Behavioral Intervention, Budgeting, Clinical Data Collection, Clinical Research, Collections Regulations, Communication Skills, Conduct Studies, Data Collection, Data Entry, Data Quality, Dental Insurance, Documentation, Flexible Spending Accounts, Health Insurance, Health Science, Healthcare, Healthcare Providers, Informed Consent, Laboratory Equipment, Maintain Compliance, Medical Treatment, Multitasking, Negotiation Skills, Operations, Operations Management, Organizational Skills, Patient Care, Pediatrics, Protocol Analysis, Reconciliation, Recruiting Strategy, Regulations, Respiratory Medicine, Retirement Plan, Risk Analysis, Risk Management, Safety Compliance, Safety/Work Safety, Scientific Research, Site Evaluation, Site Initiation, Sleep Medicine, Society of Clinical Research Associates (SoCRA)
Department
PED-ALLERGY (IN-PALG-IUINA)
Job Summary
This position manages the daily operations of pediatric pulmonary and allergy research studies, ensuring protocol compliance, participant safety, and data quality. Responsibilities include participant recruitment, informed consent, study visit coordination, data collection, regulatory documentation, and communication with investigators, sponsors, and clinical teams. This role supports the successful execution of clinical research while advancing scientific knowledge and improving patient care.
Department-Specific Responsibilities
- Oversees study coordination and execution (scheduling visits, study management, protocol implementation)
- Conducts participant recruitment, screening, and informed consent
- Facilitates study visits, assessments, participant
follow-up, specimen collection, processing, management, and shipping
- Performs data collection, entry, and source documentation
- Oversees regulatory compliance, protocol adherence, and institutional requirements
- Facilitates communication and liaison activities with investigators, sponsors, participants, and research teams
General Responsibilities
- 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 Institutional Review Board (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
Qualifications
Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.
EDUCATION / WORK EXPERIENCE
Required
- Bachelors degree in science or a health-related field and 1 year of clinical research experience; OR
- Associates degree in science or a health-related field and 2 years of clinical research experience
LICENSES AND CERTIFICATES
Preferred
- Society of Clinical Research Associates (SOCRA) / Association of Clinical Research Professionals (ACRP) clinical research certification upon date of hire
SKILLS
Required
- Demonstrates analytical skills
- Ability to simultaneously handle multiple priorities
- Possesses strong technical aptitude
- Demonstrates a high commitment to quality
- Excellent organizational skills
Working Conditions / Demands
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.
Additional Information
This position is not eligible for visa sponsorship.
Work Location
Indianapolis, Indiana
Advertised Salary
$50,000.00 - 60,000.00 per year based on a combination of experience, skill level, education, and training
Benefits Overview
For full-time staff employees, Indiana University offers a wide array of benefits including:
- 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)
Learn more about our benefits by reviewing the IU Benefit Programs Brochure.
Job Classification
Career Level: Core
FLSA: Exempt
Job Function: Research
Job Family: Clinical Research
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Posting Disclaimer
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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Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information.
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