Clinical Research Coordinator I

Responsibilities

• Provide day-to-day coordination of Hematopoietic Disease Repository, which include identifying potential subjects, tracking participants during their care, reviewing and extracting data from medical records, entering extracted data into data management system, and interacting closely with internal and external investigators who acquire resources from the repository.
• Work in collaboration with principal investigator and study staff to ensure protocol-required activities are performed in an efficient and optimal manner.
• Assist with the data management team to ensure quality control and assessment measures are appropriately maintained and kept up-to-date.
• Assure compliance with local and federal regulations.
• Take the lead in maintaining, modifying, and managing the IRO files pertaining to the Hematopoietic Disease Repository.
• Assist in development and oversight of budget activities for the Hematopoietic Disease Repository.
• Work with study staff to develop and prepare reports examining utility and success of the repository that will be provided to Fred Hutch and any other funding organization.
• Work closely with other Coordinator’s and staff to integrate enrollment and specimen collections from patients who are participating in clinical protocols treating patients of interest.

Qualifications

• High school diploma or equivalent.
• Minimum one year experience in a clinical research or cancer registry environment with regulatory or human research protections.
• Demonstrated knowledge of how to synthesis study conduct.
• Ability to apply judgement in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.
• Associate or bachelor’s degree preferred.
• Certified Clinical Research Coordinator (CCRC) or certification as Clinical Research Professional (SOCRA).
• Excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment.
• Collaborative focus is essential, as well as strong written and verbal communication skills, including computer skills.
• Two years of experience in a research environment with regulatory or human research protections.
• Previous experience working with NIH, FDA and OHRP regulations and medical terminology.
• Knowledge of clinical trials records, procedures, and computerized data processing systems.
• Ability to extract data from medical records.
• Prior experience with EPIC & OnCore Clinical Trial Management System (CTMS).
• Strong scientific writing skills.
• Outpatient Oncology experience.
• Experience with institutional regulatory processes, review of electronic medical records (EMR) and management of patient data for clinical research.
• Knowledge of medical terminology and statistics.