Clinical Research Coordinator

• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35

Position Summary

The Department of Pediatrics is seeking a Clinical Research Coordinator to join our team in a full time position to work within the division of Pediatric Hematology, Oncology, Stem Cell Transplantation. Columbia University Irving Medical Center’s Department of Pediatrics is a world leader in providing care for children. Our mission areas include Healthcare, Education and Research. We offer care for our patients in over 25 specialty areas as well as individualized care for complex cases. Our Residency, Fellowship and Graduate programs are among the best in the Nation. Our Clinical, Translational and Basic Science research features collaborations across specialties and stretches from the bench to bedside. This position will support the department by providing support to the Stem Cell Transplantation Section of our Division.

The Section of Stem Cell Transplantation at Columbia University Medical Center is recruiting for the position of a Clinical Research Coordinator (CRC). The employee will be a Columbia Officer and work within the Division of Hematology, Oncology and SCT. The section of Stem Cell Transplantation 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 of Stem Cell Transplantation, Divisional Administrator and CTO Program Manager.

Responsibilities

• Coordinate patient appointments with physicians, nurses and all test areas and schedule all protocol required evaluations (physical exams, radiology, labs, etc.
• 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 and 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 and 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 and 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 in education and experience required; plus two years of related experience.

Preferred Qualifications

• 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. 

Other Requirements

• Type other requirements and/or special indicators if CUIMC

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.