Research Study Coordinator I- Center for Individual & Genomic Medicine

As a Research Study Coordinator I, you will play a vital role in coordinating research projects within regulatory compliance guidelines. You will provide technical support to Principal Investigators, oversee recruitment, and manage day-to-day study operations. Your work ensures the smooth execution of research studies, directly impacting patient care and scientific advancement.

Responsibilities

Reviews, interprets, and maintains knowledge of study protocols, procedures, timelines, and project requirements; Utilizes and maintains study-specific databases and tracking systems, including participant recruitment, specimen management, and study supply inventories; Organizes and maintains study files, regulatory binders, source documentation, and research records; Coordinates research-related site visits, sponsor tours, and study meetings; Participates in investigator and project oversight meetings and communicates study updates to key stakeholders; Provides training, guidance, and operational support to research staff and study team members; Ensures study activities are conducted in accordance with research protocols, Good Clinical Practice (GCP), institutional policies, and federal regulations; Assists with the preparation and maintenance of regulatory submissions, study amendments, continuing reviews, and informed consent documents; Monitors, documents, and reports adverse events, protocol deviations, participant safety concerns, and privacy incidents under the direction of the Principal Investigator; Conducts quality reviews to ensure data integrity, protocol compliance, and accurate study documentation; Coordinates participant recruitment, screening, enrollment, retention, and follow-up activities; Serves as the primary contact for study participants; Develops and implements recruitment strategies in collaboration with investigators, clinical staff, and research leadership; Assesses participant eligibility and supports informed consent activities; Assists with specimen collection activities and ensures proper handling, tracking, and documentation of research samples; Coordinates research activities across multiple departments, including clinical, laboratory, radiology, pathology, and other support services; Serves as a liaison between investigators, sponsors, regulatory agencies, and research participants; Reviews and abstracts clinical research data into study databases and case report forms; Maintains research databases and study records to ensure complete, accurate, and timely data collection; Reviews data quality and resolves discrepancies in collaboration with study personnel; Generates reports and tracks study metrics, enrollment performance, and operational outcomes; Trains research staff on database functionality, study systems, and data management processes

Requirements

Bachelor's degree in a scientific discipline, Psychology, Sociology, Anthropology, Public Health, Healthcare Administration, or a related field; Knowledge of and experience working with human subjects research, including informed consent and research compliance requirements; Phlebotomy experience, including blood specimen collection, processing, and handling

Nice to have

Experience interacting directly with patients in clinical, research, or healthcare settings; Proficiency in Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook; Experience maintaining study documentation, source documents, regulatory binders, and case report forms; Phlebotomy Experience or Certification; SOCRA or ACRP certification preferred; IATA certification preferred

Benefits

Opportunities for continuous learning and professional development