Clinical Research Coordinator

One of the first human genetics departments in the country, the Department of Medical and Molecular Genetics at Indiana University (IU) School of Medicine has a rich history of training geneticists and genetic counselors and providing genetic consultation and counseling services. Currently ranked 5th in the nation among Genetics Departments for National Institutes of Health (NIH) Funding, received in 2023, the department contributes to the understanding of numerous genetic conditions through the integration of basic research in genetic and genomic mechanisms, translational research in disease models, and clinical trials in rare and common genetic diseases.

This position serves as the lead coordinator for IU Digital Core supporting the Michael J. Fox Foundation's Platform Trial Program (P2P), a multi-site master protocol evaluating multiple investigational therapies for Parkinson's disease.

• Oversees the complete lifecycle of device management-inventory control, device activation and assignment, shipment to study sites, participant support, device return, data transfer, quality assurance, and regulatory compliance
• Programs and assigns wearable devices for scheduled study visits, maintains device accountability logs, ensures accurate documentation, monitors inventory, and ensures timely receipt and redistribution of devices. Manages secure transfer of digital data and verifies quality in accordance with the protocol.
• Coordinates all operational activities related to the digital biomarker component of the study across participating United States (US) and outside of United States (OUS) sites
• Leads Digital Core operations, manages digital device lifecycle and inventory, coordinates digital data management and quality assurance, regulatory compliance and technical support, training, process improvement, and documentation

• 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 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 Principal Investigator (PI) and sub-investigators
• Stays up to date with knowledge of regulatory affairs and/or issues

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.

• 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

• 3 years of clinical…