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Clinical Research Coordinator

Pediatrics

Clinical Research Coordinator

  • 528309
  • Medical Center
  • Pediatrics
  • Full Time
  • Opening on: Aug 2 2022
  • Grade 103
  • Job Type: Officer of Administration
  • Bargaining Unit:
  • Regular/Temporary: Regular
  • End Date if Temporary:
  • Hours Per Week: 35
  • Salary Range:
 

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. We also have several active Clinical trials available to our patients. This position will support the department by providing clinical trial research duties to the Division of Pediatric Hematology, Oncology & Stem Cell Transplantation.

"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. and 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 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, in addition maintain study supplies and utilizes study specific supplies as required. 
  • Assists the Principal  Investigator 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 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 Principal Investigator 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.

Equal Opportunity Employer / Disability / Veteran

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

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