Job Summary

Directs and leads all aspects of clinical, regulatory, business, and other research- related activities and documentation for clinical trials on behalf of the Levine Cancer Institute, following industry standards and applicable regulations including FDA/OHRP guidance, GCP and ICH.

Essential Functions

• Competently fulfills the job responsibilities of the Oncology Research Consultant, and:
• Coordinates the clinical care of patients being evaluated for and/or patients already participating in the trial program, including research activities, and education as appropriate.
• Coordinates clinical care throughout the program utilizing pathways, and developing tools to ensure high quality, cost effective continuity of care.
• Ensuring compliance with federal and institutional research regulations.
• Ensures a master file of protocols with requisite regulatory requirements, data forms, source documentation and patient files is maintained.
• Coordinates research site selection, monitor, audit, QA and regulatory visits.
• Educates patients and families about research studies, treatments, side effects and follow-up, as appropriate.
• Supervises and coordinates assigned programs across clinics/sites.
• Coordinates, follows, and evaluates patient participation in clinical trials to ensure compliance with the protocol. Provides accrual and other metrics to leadership.
• Performs protocol specific tasks including patient assessment, eligibility screening, specimen collection, toxicity assessment, and monitoring of responses.
• Manages protocol and program quality assurance activities, monitoring visits, and audits. Works with research team to ensure that regulatory findings and data queries are resolved.
• Collaborates with principal investigator(s) to assist in developing plans for research projects and to discuss the interpretation of results; collaborates on the preparation of manuscripts for publication.
• Coordinates the regulatory coordination in preparing and submitting accurate study materials, interim reports, annual reports, amendments and case records to sponsors and the IRB as required within the designated time period.

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 and 5 or more years of clinical research experience with a pharmaceutical company or Contract Research Organization or equivalent experience required; or Master’s Degree and 4 or more years of clinical research experience with a pharmaceutical company or Contract Research Organization or equivalent experience required; or a minimum of 9 years clinical research experience with a pharmaceutical company or Contract Research Organization or equivalent experience required with no degree. Bachelor’s Degree in Nursing or Master’s Degree in Nursing or other health/science degree concentration preferred. CPR certification required. Previous experience in a healthcare setting required, especially in a cancer care and/or cancer research environment. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) required. Certification in oncology nursing specialty preferred (OCN®, CPHON®, AOCNP®, AOCNS®, CBCN®, etc.). Supervisory experience or experience leading teams required.