This highly visible Clinical Research Coordinator role will support the world renown IR Team at Adventist Midwest Health. This position has a regional focus and will support 6 Physicians, 4 hospitals and one clinic. The research performed by this team is ground breaking research. The group has been published many times and speaks internationally. Why not join a team of the best?
The position manages daily process of conducting clinical research. Recruits for and registers patients in clinical research studies. Analyzes and evalutes clinical data to determine proper treatment per protocol.Completes data reporting requirements. Manages compliance with regulatory reporting requirements.Ensures compliance with protocol and overall clinical objectives,.Knowledge of FDA regulatory requirements is required.Familiar with standard concepts, practices, and procedures within a particular field. Coordinates and is responsible for the daily work operations within the clinical research programs to ensure compliance with standards of the GCP (Good Clinical Practice), FDA (Food and Drug Administration), OHRP (Office of Human Research Protection) guidelines, National Cancer Institute and other associated agencies involved in monitoring research activities.
· Bachelor’s degree in health-related field required; clinical area preferred.
· Certification/licensure: RN preferred; CCRP-, CCRA-eligible preferred.
· Minimum 3-5 years’ experience working in clinical research department, performing eligibility screening, patient registration, treatment coordination with caregivers, data collection and submission.
· Experience in operating computerized database systems and computer software applications (word processing, spreadsheet and graphics) required.
· Medical terminology required.
· 20 wpm typing speed required.
· Understanding of therapeutic areas preferred.
· Understands GCP (Good Clinical Practice), FDA (Food and Drug Administration), OHRP (Office of Human Research Protection) guidelines and regulations regarding research conduct and oversight.
· Ability to search, download and report using Internet sites.
· Ability to interpret medical test results.
· Ability to read, write speak and understand English.
· Ability to operate equipment that may be necessary to perform job duties.