Indiana University · 20 hours ago
Clinical Research Specialist, Pediatric Endocrinology/Diabetology
Indianapolis, IN
Full-time
Onsite
Entry Level
$48K/yr - $53K/yr
1+ years expIndiana University is dedicated to promoting the health of children with endocrine disorders through research and clinical services. They are seeking a Clinical Research Specialist to manage research studies, recruit subjects, and ensure compliance with protocols while providing support to the research team.
Higher Education
No H1B
Responsibilities
Recruits subjects according to IRB/protocol approved methodology; consent subjects, including discussion of treatment and intervention alternatives
Monitors enrollment goals and modifies recruitment strategies as needed. Liaisons with healthcare professionals/providers to determine breast recruitment practices for study; manager, subject, recruitment, including marketing
Ensures proper collection, processing, shipment of specimens, and documentation; communicate with laboratory, principal, investigator, and sponsor regarding laboratory findings; records and documents protocol deviations; communicate with PI and investigators about changes in the trial
Schedules study related meetings and training sessions and provides instructions to study team for specific study assignments, trains ancillary staff regarding clinical studies or trials
Manages research, study inventory and supplies (such as medications, equipment, devices) and maintains required compliance documentation
Prepares and submits institutional review board (IRB) documents, such as informed consent, advertisement protocol, and protocol summary
Composes and submit continuing review/amendment/close out information; schedules and prepares for monitor visits; prepares in response to sponsor and/or FDA audits
Assists with identifying and recruiting potential research study subjects; determines eligibility according to the IRB/protocol approved methodologies, coordinates study procedures, and monitors the progress of research studies or projects
Conducts study visit activities and coordinates screening, consenting, and scheduling of test, exams, and/or non-medical/behavioral interventions and assessments involving study subjects. Coordinates, facilitates, and performs various study activities; manages all follow-up activities with subjects based on protocols
Records study data, samples, and/or results in various databases. Maintains databases for subjects and subject scheduling. Performs data validation checks and pursues resolutions to erroneous data. Produces various reports in response to requests from principal investigator (PI), sub-investigators, and/or other study stakeholders
Monitors study team compliance with protocol and standard operating procedures (SOPs). Submits all regulatory paperwork required. Communicates with PI and sub-investigators about concerns or recommended changes in study protocols, etc
Assists with developing various communications and strategies for advertising and recruitment, as well as in developing information materials for study participants
Stays up to date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings
Provides various other clinical research study or project support as needed (such as assisting with budget development, invoicing for adverse events, billing compliance and patient billing resolution)
May provide guidance and/or support to less experience clinical research staff
Qualification
Required
Bachelor's degree in science or a health-related field and 1 year of health-related or research experience
Associate's degree in an allied health profession and 3 years of health-related or research experience
Proficient communication skills
Maintains a high degree of professionalism
Demonstrates time management and priority setting skills
Demonstrates a high commitment to quality
Possesses flexibility to work in a fast paced, dynamic environment
Highly thorough and dependable
Possesses a high degree of initiative
Ability to build strong customer relationships
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
Indiana University
Indiana University looked for ways to promote innovation while assisting students in building better futures.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Nancy Paton
Vice President & Chief Communications and Marketing Officer
Aaron Neal
Deputy CIO
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