Clinical Research Coordinator 2
Current- Assists in participant recruitment and retention activities, and assists in screening potential study participants for eligibility.- Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols.- Collects, processes, packs, and ships specimens according to protocol, applicable standards and regulations.- Maintains study binders and filings according to protocol requirements, UM and department policy.-… Show more - Assists in participant recruitment and retention activities, and assists in screening potential study participants for eligibility.- Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols.- Collects, processes, packs, and ships specimens according to protocol, applicable standards and regulations.- Maintains study binders and filings according to protocol requirements, UM and department policy.- Distributes study drug materials according to practice standards and clinical credentials as delegated by the Principal Investigator.- Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations.- Assists in implementing protocol amendments under direct supervision of the Principal Investigator.- Assists with study orientation and protocol related in-services to research team and clinical staff.- Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule.- Learns the research team and assists with communications/interactions with sponsor, data coordinating centers, compliance monitors, collaborators, investigators’ academic administrative personnel, and departments.- Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews.- Adheres to cultural competency guidelines; implements strategies to meet study participants’ needs for language translation, health literacy, etc.- Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.- Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies. Show less
