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Coordinator - Oncology Research - RN -Investigator-Initiated Research Clinical Project Coordinator

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Charlotte, NC, United States
Job ID: 18242
Job Family: Nursing
Status: Full Time
Shift: Day
Shift Details: Regular
Department Name: 11011036640304-Clinical Trials - LCI
Location: LCI - 1021 Morehead Medical Dr

Overview

Job Summary

Coordinates the clinical, regulatory, business, and other research- related activities and documentation for clinical trials conducted by the Levine Cancer Institute, following industry standards and applicable regulations including FDA/OHRP guidances, GCP and ICH.

Additional Essential Functions

  • Working on behalf of the sponsor, collaborates with the Levine Cancer Institute (LCI) Investigator-Initiated Research (IIR) Clinical Project Manager and other sponsor-level stakeholders to oversee study conduct on LCI-sponsored clinical trials
  • Reviews LCI-sponsored clinical trials in development and amendments from a clinical operations perspective; participates in protocol and data element review meetings as applicable
  • Coordinates and leads applicable sponsor-led meetings with key stakeholders
  • Prepares agendas and minutes for LCI-sponsored study team meetings
  • Reviews and assesses LCI sponsored protocol questions from study conduct sites and provides appropriate feedback
  • Assists with/facilitates amendments to LCI-sponsored clinical trials
  • Ensures contractual requirements with external collaborators are being met; writes and sends progress reports on LCI-sponsored clinical trials per funder requirements
  • Facilitates completion of Data and Safety Monitoring Committee reports for LCI-sponsored clinical trials
  • Reviews, queries, and reports all expedited safety event and deviation reports received from study conduct sites on LCI-sponsored clinical trials
  • Creates and conducts applicable Site Initiation Visit and amendment training for study conduct sites


Essential Functions

  • Competently fulfills the job responsibilities of the Oncology Research Specialist, and:
  • Coordinates clinical and regulatory document submissions for clinical trial start-up, consent development and amendment, protocol amendment, continuing review, closure to accrual, action letter, suspension, termination and other reportable regulatory information.
  • Assesses patient eligibility through chart reviews and patient/family interviews.
  • Assists in providing patient education regarding the nature of their disease and the benefits/risks of participating in a clinical drug trial.
  • Collaborates with regulatory team, Principal Investigator, Sub-Investigators, study personnel, IRB, sponsor/CRO/monitor and other internal/external customers to efficiently coordinate documentation/submissions. Conducts routine NCI research base/sponsor website reviews to identify regulatory updates and actions required.
  • Presents and obtains patient informed consent.
  • Coordinates accurate data collection and record keeping by reviewing documents and processes for quality assurance.
  • Ensures timely and accurate submission of data.
  • Coordinates and prepares for internal and external audits.
  • Participates in sponsor study start-up and follow-up meetings as appropriate.
  • Develops study calendars.
  • Collaborates on billing and financial activity with Research Finance (budgets and billing compliance).
  • Coordinates scheduling of patient visits, labs, and diagnostic procedures across LCI locations.
  • Coordinates drug shipments, storage, and accountability with IDS/Pharmacy.
  • Assists in the development, improvement and review of Standard Operating Procedures and processes.
  • Provides educational and technical assistance to research staff including orientation and mentoring of new research staff.
  • Collaborates and participates with teams across the LCI enterprise in a professional and courteous manner.
  • Interacts professionally with patients and families.

    Additional Training and Certifications

  • Clinical experience in Oncology preferred
  • Ability to review and understand all aspects of a clinical trial
  • Experience in serious adverse event reporting
  • Collaborative attitude, with excellent verbal and written communication skills
  • Organized, with ability to follow through, track, and follow-up on numerous ongoing initiatives
  • Self-motivated and deadline-oriented, able to multi-task and function autonomously
Physical Requirements

Primarily works in an office setting. Requires full range of body motion; sitting for extensive periods of time; walking, standing, reading, and writing/keyboarding. Occasionally lifts and carries items weighing up to 35 pounds. Requires corrected vision and hearing within normal range. Must speak and read/write clearly in English. Must be able to be mobile within the entire healthcare system and other locations that participate in LCI clinical trials.


Education, Experience and Certifications

Must hold a valid North Carolina or South Carolina (as applicable) Board of Nursing license. Bachelor’s Degree (BS) and 1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or Master’s Degree (MS) and 0-1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or a minimum of 3 years clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required with no degree. Bachelor’s Degree in Nursing (BSN) or Master’s Degree in Nursing (MSN) or other health/science degree concentration preferred. CPR certification required. Previous experience in a healthcare setting preferred, especially cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred.