The Department of Pediatrics is seeking a Clinical Research Coordinator to join our team in a full time position. 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. We also have several active Clinical trials available to our patients. The Incumbent will work for the Division of Pediatrics Hematology, Oncology and Blood Marrow Transplant (BMT) in the section of Oncology at Columbia University Irving Medical Center. Oversee a portfolio of consortium-based and industry-sponsored Phase II and III clinical trials. The division plays active roles in the Children's Oncology Group (COG) and Dana Farber Cancer Institute (DFCI)/Acute Lymphoblastic Leukemia (ALL) consortium. The CRC will be responsible for the coordination, oversight and administration of clinical research protocols from the Children's Oncology Group, the DFCI/ALL consortium, and other cooperative groups, as applicable. General duties include working with research nurses, study physicians, and principal/co-investigators to confirm patient eligibility, enroll patients onto trials, collect and submit required data to sponsors, process samples and report. The CRC will participate in site initiation visits with sponsors as well as all monitoring visits with the sponsor or sponsor's designee (eg: clinical research organization hired by the sponsor). In addition, the CRC will coordinate and provide oversight of audit preparation including reviewing pharmacy records, regulatory, and data collection. The CRC will ensure that requirements for enrollment on clinical trials and data management requirements. The CRC will work under the supervision of the Principal Investigator(s), Director of Research, and Divisional Administrator.
Duties and Responsibilities:
Serves as a primary contact for research participants, sponsors, Principal/ co-investigators, and other study staff.
Reviews and develops a familiarity with protocols, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
Determine the eligibility of study participants according to protocol guidelines.
Assists in developing recruitment strategies.
Registers new patients onto studies in a timely manner.
Registers each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source.
Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
Collects, spins, separates and prepares specimens when needed; ships requested specimens in a timely manner.
Collects and submits tumor tissue samples and pathology slides as required.
Provides in-service education and on-going communication to CRC peers and collaborating institutions with study updates.
Reviews medical records, enters, and tracks all patient data into the appropriate data collection systems.
Completes study documentation and maintains study files in accordance with COG, other consortium, or industry requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
Works with the Regulatory Coordinator to submit all protocol modifications, amendments, and renewals to COG, NCI, the IRB, and Cancer Center within the required timelines
Prepares all materials for both institutional and cooperative group audits.
All other duties as assigned.
Requires a Bachelor's degree or equivalent in education and experience required plus two years of related experience.
Training and experience in a health science discipline, such as public health, nursing, health services research, physiology, biochemistry or equivalent preferred.
Minimum of 2 to 3 years of clinical research or other applicable research experience preferred.
Clinical research or other applicable research experience in hematology, oncology or bone marrow transplantation preferred.
Must be detail-oriented, with excellent organizational, interpersonal, written and oral communication skills, strong time management skills, ability to make decisions, and strong multitasking abilities are key attributes for this position.
Strong knowledge of medical terminology and competency in working with databases and conducting data abstraction, data entry, and generating reports.
Light Level of Physical Activity Required
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 513831
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.