Department
PED-HEALTH SERVICES RESEARCH (IN-PHSR-IUINA)
Department Information
The Department of Pediatrics employs nearly 1,000 faculty and staff who work alongside employees of Riley Hospital for Children and students of Indiana University (IU) School of Medicine (IUSM) to make Riley Childrens Health Indianas largest and most skilled pediatric system. At IUSM, our mission and core values define who we are, how we act, and what we aspire to accomplish.
Job Summary
This position as the research coordinator will play a key role in supporting the implementation and evaluation of a research study focused on improving autism diagnostic training for primary care clinicians. Working closely with investigators, clinical partners, and community stakeholders, the position contributes to advancing evidence-based approaches for expanding access to autism diagnostic services in primary care settings.
Department-Specific Responsibilities
- Supports the studys goal of reducing delays in autism diagnosis by helping identify effective strategies for training clinicians to provide high-quality diagnostic evaluations within their communities.
- Coordinates day-to-day study activities, recruits and engages participating clinicians, facilitates training and learning activities, collects and manages study data, and ensures compliance with regulatory and research protocols.
- Coordinates day-to-day research activities for a complex, multisite pediatric autism research study under the direction of Dr. Rebecca McNally and Lab Manager.
- Serves as a primary point of contact for study participants and assists with communication among participating sites, investigators, clinicians, caregivers, and research personnel.
- Coordinates participant recruitment, eligibility screening, informed consent, enrollment, scheduling, retention, and follow-up activities for primary care clinicians (PCCs) and caregivers.
- Maintains regular communication with participants to support engagement, study adherence, and timely completion of study activities.
- Tracks participant progress across all study phases, including screening, consent, baseline assessments, training activities, post-training assessments, and longitudinal follow-up.
- Assists with preparation, submission, and maintenance of regulatory documents, including IRB applications, amendments, continuing reviews, reportable events, protocol deviations, study reports, and closeout activities.
- Maintains regulatory binders, essential study documents, consent records, training documentation, delegation logs, data dictionaries, study manuals, and investigator files.
- Ensures regulatory documentation is complete, organized, and maintained in accordance with sponsor, institutional, and federal requirements.
- Maintains study communication records and supports collaboration among investigators, site personnel, consultants, advisory groups, and research teams to facilitate completion of study milestones and deliverables.
- Coordinates research data collection using REDCap and other approved study systems.
- Assists participants with survey completion and data submission and provides support related to study questionnaires and electronic platforms.
- Reviews study records routinely to ensure completeness, accuracy, and compliance with protocol requirements.
- Conducts quality assurance reviews of participant eligibility documentation, consent forms, survey completion, training records, follow-up assessments, and study tracking systems.
- Identifies missing data, incomplete records, and data discrepancies and follows up with participants and study personnel to facilitate resolution.
- Coordinates implementation of clinician training activities throughout the study and serves as a primary resource for participants regarding training requirements, study expectations, timelines, and completion criteria.
- Maintains detailed tracking systems for participant completion of assigned training components, including didactic education modules, case-based observation activities, case-based practicum activities, learning collaborative participation, coaching sessions, and post-training assessments.
- Monitors participant progress throughout the training phase and conducts routine reviews to ensure completion of required activities.
- Communicates reminders regarding upcoming deadlines, incomplete training requirements, missed sessions, and follow-up tasks.
- Documents participant interactions and study communications.
General Responsibilities
- 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 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 plus 2 years of clinical research experience; OR
- Associates degree in science or a health-related field plus 3 years of clinical research experience.
LICENSES AND CERTIFICATES
Preferred
- SOCRA/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
$57,000.00 - $67,000.00 annually
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: Career
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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