CURRENT OPPORTUNITIES

• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range: $58,500-$65,000

Position Summary

The Initiative for Drug Delivery Innovation (IDDI) program at The Vagelos College of Physicians & Surgeons of Columbia University is recruiting for the position of a Clinical Research Coordinator (CRC). The incumbent will be a Columbia University Officer of Administration (OOA) and work within the section of Pediatric Neuro Oncology. The Initiative for Drug Delivery Innovation (IDDI) program has a cadre of Phase 1 and 2 trials investigator initiated studies. The Clinical Research Coordinator will be assigned to all studies involved in the IDDI program. The Clinical Research Coordinator 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 Clinical Research Coordinator will work under the supervision of the Section Head of Oncology, Divisional Administrator, IDDI Program PIs, and IDDI Program Coordinator. 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. 

At CUIMC, we are leaders in teaching, research, and patient care and are proud of the service and support we provide to our community. We apply the same rigor in our commitment to fostering an inclusive, thriving community and caring for our employees and their loved ones. We offer immediate eligibility and invest in our employees’ families through comprehensive Health and Welfare, Employee Assistance, Tuition Programs, and Retirement Benefits.

"Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process".

Responsibilities

• Schedules all protocol required evaluations (physical exams, radiology, labs, etc.).
• Coordinates and track patient study appointments with physicians, nurses and all test areas.
• Attend Investigator meetings which establish required procedures.
• Coordinates, obtains, processes (e.g. spin/separate/freeze samples), and ships (e.g. utilization of specific packaging and ensuring proper handling and shipping of samples) protocol required samples.
• Maintains accurate patient research files and records of sample procurement.
• Maintains study supplies and utilizes study specific supplies.
• Ensures all protocol related data is collected and recorded in data management system and stored internally. 
• Efficiently and appropriately identifies and preliminarily grade all AEs/SAEs that occur in any participant on any research study for which they are primarily responsible.
• Responsible for identifying all pertinent information about the AE/SAE, including but not limited to the type of AE/SAE, time points of occurrence, and symptoms relating to the AE/SAE to be presented to the next member of the clinical research team (NP/PI).
• Assists study team 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 and maintains documentation of training.
• Assists study team 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. 
• Collaborates with study team with regulatory and reporting requirements as outlined in individual studies.
• 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.
• Prepares, maintains and organizes regulatory files for each assigned study in compliance with study sponsor requirements, PCFDTP etc.
• Tracks and manages assigned new protocol start-up packet; initiates, facilitates and monitors study start-up progress.
• Creates and maintains tracking for all subsequent submissions to the SRC/IRB; protocol and consent amendments, all required safety reporting, all required deviations/violations, etc.
• Coordinates assigned study monitoring and auditing visits with study team, investigator, industry sponsors, and internal/external auditors. Notifies appropriate institutional officials of external audits by FDA and sponsors.
• Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion.
• 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.

Equal Opportunity Employer / Disability / Veteran

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