Note: The job is a remote job and is open to candidates in USA. Indiana University is dedicated to excellence in research, education, and patient care in the field of cardiovascular medicine. They are seeking a Clinical Research Coordinator to initiate and conduct protocol reviews, manage study budgets, and ensure compliance with regulations while overseeing the recruitment and assessment of study subjects.
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
Skills
- 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
- Society of Clinical Research Associates (SOCRA) / Association of Clinical Research Professionals (ACRP) 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)
- This position is eligible for remote work or to work a hybrid schedule (mix between remote and in-person work), subject to change in the future based on university policy and business needs.
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