Indiana University is a leading institution in human genetics, known for its rich history in training geneticists and providing genetic consultation services. The Clinical Research Coordinator will conduct protocol reviews, manage study activities, and ensure compliance with regulations in clinical research studies.
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 Investigators (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 1 year of clinical research experience; OR
- Associate's degree in science or a health-related field and 2 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
- The Society of Clinical Research Associates and the Association of Clinical Research Professionals (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 Overview
Indiana University looked for ways to promote innovation while assisting students in building better futures. It was founded in 1820, and is headquartered in Bloomington, Indiana, USA, with a workforce of 10001+ employees. Its website is https://www.iu.edu.
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