Clinical Research Coordinator

Position Summary The Section of Oncology at Columbia University Medical Center is recruiting for the position of a Clinical Research Coordinator (CRC). The employee will work within the Division of Hematology, Oncology and Stem Cell Transplantation. The section of Oncology has a cadre of Phase 1 and 2 trials, investigator-initiated studies, and industry sponsored studies. The CRC will be assigned to studies based on need and review of clinical trial roster. The CRC will work with investigators, study staff, Scientific Review Committee (SRC) and institutional review boards (IRB), clinical trial sponsors and federal regulatory agencies to assure compliance with study protocols, data documentation, reporting requirements, ensure that regulatory requirements for clinical trials are met. The CRC will work under the supervision of the Section Head, Divisional Administrator and CTO Program Manager. “Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process.” Responsibilities Schedule all protocol required evaluations (physical exams, radiology, labs, etc.) Coordinate patient appointments with physicians, nurses and all test areas. Attend Investigator meetings, which establish required procedures. Coordinate, obtain, process (e.g., spin/separate/freeze samples), and ship (e.g., utilization of specific packaging and ensuring proper handling and shipping of samples) protocol required samples. Obtain vital signs and EKGs as indicated. Maintain accurate patient research files and records of sample procurement. Develop protocol specific flow charts, intake sheets and other tools as needed to ensure protocol compliance and proper data acquisition. Maintain study supplies and utilizes study specific supplies as required. Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training. Assists Principal Investigator to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures. Cooperates with university compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office. Coordinates and facilitates monitoring auditing visits and notifies appropriate institutional officials of external audits by FDA and sponsors. Collaborates with PI and institution to respond to any audit findings and implement-approved recommendations. Cooperates with university and sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office. Establish and maintain regular communication with study team, study sponsor, and applicable regulatory agencies to ensure all required information is communicated. Serve as facilitator for study team and sponsor with regard to study status information, safety issues, upcoming protocol amendments, consent changes, and applicable protocol training. Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval. Prepares and submits regulatory documentation that may include IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug Administration (FDA) etc. Coordinates assigned study monitoring and auditing visits with study coordinator, investigator, industry sponsors, and internal/external auditors. Performs related duties & responsibilities as assigned/requested. Minimum Qualifications Bachelor’s degree or equivalent and experience required. Preferred Qualifications Two years of related experience. Protocol oversight; monitoring and reporting of study events; data collection; adherence to study protocols; in-service education of physicians, nurses, and support staff to protocol requirements; coordinate research activities. Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents. #J-18808-Ljbffr Columbia University in the City of New York