Clinical Research Coordinator

3 weeks ago

Lafayette, United States Medix Full time

Description:

The clinical research Coordaintor manages the screening, enrollment, and maintenance of patients on clinical trials. Duties include assuring protocol compliance for all patients on trial, participation in consent process, ongoing assessments for changes in condition and adverse events, accurate and timely documentation/data entry, responsible for education and training of other staff and patients, understands the strategic and operational objectives of the research program, may performs high level financial work including budget oversight. Trains and promotes professional development of staff. Ensures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.

Responsibilities:

  • Screens potential patients for protocol eligibility
  • Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on clinical trials
  • Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on clinical trials
  • Responsible for review of consents to ensure proper execution of the informed consent process for study subjects
  • Coordinates patient care in compliance with protocol requirements
  • Disburses investigational drug and provide patient teaching regarding administration and other patient educational needs
  • Maintains investigational drug accountability
  • Oversees the preparation of orders by physicians to assure that protocol compliance is maintained
  • Working independently, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents and reports all findings to physician and care team
  • Communicates with physician regarding study requirements, need for dose modification, and adverse event reporting Provide clinical services as required including patient assessments
  • Responsible for reviewing protocol specific billing guides and submitting billing information to appropriate personnel
  • Responsible for compiling and reporting protocol activity, accrual data, and research financials to practice administration and physicians
  • May be responsible for the development of practice research budgets
  • Maintains regulatory documents in accordance with USOR SOP and applicable regulations
  • Participate in scheduling monitoring and auditing visits
  • Interacts with the monitors/auditors while on-site
  • Provide input in determining, and implementing improvements to policies/processes
  • Works with clinic staff to solve complex issues around patient trial participation
  • Develops SOPs in collaboration with research and clinical teams
  • Due to expertise in subject matter, functions in a lead role as a resource for research staff
  • Conduct protocol-specific training for study personnel to include training of staff in preparation for study activities Review protocols and provide input on study activities in relation to areas of responsibility
  • May work with SRL to determine study recruitment and enrollment goals
  • Oversees subject recruitment and study enrollment to meet goals
  • Leads efforts to find effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials Assists SRL in feasibility assessments and study selection

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