Assist with research department operations including SOP development, department start-up activities, equipment ordering, invoicing, expense tracking, and study feasibility assessments
Research new study and business opportunities through government and industry resources such as ClinicalTrials.gov
Coordinate assigned clinical trials, including managing timelines, budgets, study documentation, and regulatory requirements
Support patient recruitment, screening, informed consent, and retention efforts
Conduct protocol reviews and communicate study requirements, inclusion/exclusion criteria, and protocol updates to research staff and applicable departments
Collect, organize, and maintain accurate clinical research data; perform data entry, query resolution, and quality checks
Ensure study staff are trained on protocols, electronic systems, and study procedures
Attend sponsor meetings and study trainings and communicate study expectations to internal teams
Assist in mentoring and supporting research staff while promoting a collaborative team environment
Coordinate with internal departments, sponsors, and IRBs to ensure smooth study execution and compliance with GCP and institutional guidelines
Qualifications
Bachelor’s degree in a scientific, healthcare, or research-related field preferred
Prior clinical research experience as a Clinical Research Coordinator, Research Assistant, or similar role required
GCP, ACRP, and/or IATA certification preferred or willingness to obtain certification
Strong understanding of clinical research processes, SOPs, and regulatory requirements
Experience with EMR systems, electronic data capture platforms, and clinical documentation
Excellent organizational, communication, and project management skills with the ability to manage multiple studies simultaneously