Indiana University · 13 hours ago
Clinical Research Coordinator
Indianapolis, IN
Full-time
Onsite
Entry, Mid Level
2+ years expIndiana University is a leading institution in the field of family medicine, providing comprehensive healthcare services. They are seeking a Clinical Research Coordinator to initiate and conduct protocol reviews, oversee compliance with regulations, and manage clinical research studies.
Higher Education
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
Qualification
Required
Bachelor's degree in science or a health-related field and 2 years of clinical research experience
OR Associate's degree in science or a health-related field and 3 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
Preferred
SOCRA/ARCP 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)
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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