Senior Clinical Research Coordinator - Pediatrics Hematology & Oncology

Washington University in St. LouisAnn Arbor, MI
54d$62,000 - $96,100

About The Position

Position oversees and coordinates complex or multi-site clinical research studies; serves as a resource to provide comprehensive information to clinical research staff by promoting a smooth operation, preparation of regulatory compliance and interaction with other departments; responsible for assisting in budgetary reports and ensuring billing and regulatory compliance standards are maintained; may supervise clinical research staff.

Requirements

  • Bachelor’s degree or combination of education and/or experience may substitute for minimum education
  • Basic Life Support - American Heart Association
  • Basic Life Support - American Red Cross
  • Clinical Research (3 Years)
  • Supervision

Nice To Haves

  • SoCRA or ACRP certification
  • Experience in Pediatrics and/or Oncology
  • Experience with pharmaceutical sponsored therapeutic protocols
  • Master's degree
  • Clinical Research Management
  • Clinical Study Protocols
  • Database Management
  • Research Projects
  • Spreadsheet Analysis
  • Statistical Analysis Software (SAS)

Responsibilities

  • Manages protocol study start up and study launch, submission, and maintenance of essential regulatory documents
  • Assists in budget review and invoice tracking
  • Assists in scheduling and facilitating site visits by external and internal monitors and auditors
  • Provides high level of direct and indirect support
  • Works with PI to evaluate research procedures
  • Confers with PI to assist in developing plans for research projects
  • Provides input of feasibility, cost, and workload in regards to participating in new clinical trials
  • Serves as a resource to clinical research staff, ensuring appropriate procedures, and explains policies and procedures
  • Ensures that research projects are completed according to IRB and federal guidelines
  • Develops and implements policies and procedures
  • Provides comprehensive direction to clinical research personnel
  • May participate in the hiring, training, and evaluation of clinical research staff
  • Serves as a subject matter expert for clinical group and acts as a resource for protocol related questions
  • Facilitates communication with PIs to ensure that study objectives are met in a timely manner
  • Maintains a cooperative relationship with Hematology/Oncology and other divisions and departments
  • Researches and recommends new methods and procedures to maintain standards and improve quality
  • Provides study coordinator functions and performs all duties associated with the coordination and implementation of clinical research study/projects, data collection, and the management of data generated by study protocols
  • Consents participants for non-therapeutic clinical trials
  • Performs other duties incidental to the work described above

Benefits

  • Up to 22 days of vacation, 10 recognized holidays, and sick time.
  • Competitive health insurance packages with priority appointments and lower copays/coinsurance.
  • Take advantage of our free Metro transit U-Pass for eligible employees.
  • WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%.
  • Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!
  • We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We’ve got you covered.
  • WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us.
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