The Department of Pediatrics is seeking a Clinical Research Coordinator to join our team in a full time position to work within the Hematology Section. Columbia University 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. We also have several active Clinical trials available to our patients. The section of Hematology conducts several Phase 1 and 2 trials and other studies. The Clinical Research Coordinator (CRC) will be responsible for both clinical and regulatory oversight of the Hematology clinical study portfolio. The CRC will work with investigators, study staff, research subjects, institutional review boards (IRB), and clinical trial sponsors to assure compliance with study protocols, data documentation and study data entry, reporting requirements, and regulatory. The CRC will work under the supervision of the Section Head of Hematology and the Divisional Administrator.
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.
Screen patient electronic medical records and lists for eligible study subjects, and contact patients about potential interest in study participation. Provide potential subjects with study information.
Obtain informed consent for subject enrollment into clinical studies.
Organize and implement study procedures for clinical trials and other human subject studies, such as contacting subject for scheduled clinical visits, and organizing study visits (e.g. for sample collection, survey collection) to fulfill protocol requirements.
Prepare routine reports on study patient screening, eligibility, enrollment and retention.
Organize data collection and storage, and perform data entry in study electronic databases.
Prepare and submit protocol applications, amendments, continuing reviews, and informed consent documents for Columbia or other IRB review and approval.
As applicable, establish and maintain regular communication with study team and study sponsor to ensure communication of required information.
Serve as facilitator for study team and sponsor with regard to study status information, safety issues, changes to protocol and consent, and protocol training. Attend sponsor study update meetings.
Coordinate assigned study monitoring and auditing visits with principal and other investigators, industry sponsors, and internal/external auditors.
Prepare and submit timely regulatory documentation (e.g. protocol applications, amendments, continuing reviews, informed consent documents, reporting adverse events), to the Columbia IRB, DSMC and other human research oversight mechanisms, as applicable.
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. Notifies appropriate institutional officials of external audits by FDA and sponsors.
Collaborates with the PI and Columbia in compliance and monitoring efforts related to human research participant protection; reports instances of noncompliance to the appropriate compliance office; is responsive to any audit findings, and assists the PI in implementing approved recommendations.
All other duties as assigned
Requires a bachelor's degree or equivalent in education, training and experience, plus 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.
Internal Number: 512611
About Columbia University
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.