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Overview

Job Summary

Manages a team and coordinates all aspects of oncology clinical trials. Collaborates with internal groups and externally with trial sponsors, contract research organizations, monitors, auditors, regulatory bodies and others.

Essential Functions

• Manages multiple projects and ongoing work activities ensuring work plans and deliverables are met.
• Ensures follow-up on trial subject safety matters as well as regulatory management of trials in their portfolio.
• Allocates resources appropriately to meet departmental needs.
• Recruits; interviews; onboards; trains; mentors and coaches; manages performance; works across teams to collaborate on recruitment process.
• Communicates with teammates and manages remote training/dialogue.
• Assists with training teammates across enterprise as it relates to a specific trial, project, or process.
• Coordinates and manages study subjects; educates subjects and families about research studies, treatments, side effects, and follow-up; ensures subject eligibility for participation in clinical trial, ensures timely and accurate data collection and reporting, maintains appropriate documentation on study subjects, as required by the sponsor and standard practices.
• Assists teammates with start-up, contracting and regulatory process for sponsored projects, develops project-related budgets, tracks project financial performance, time and effort reports, resolution of subject billing issues, and fiscal stewardship of departmental resources.
• Ensures all aspects of the team's work is accomplished in compliance with accepted Good Clinical Practice (GCP), ICH, OHRP, FDA, corporate and departmental SOPs, and applicable state/federal law.
• Manages safety of research subjects by oversight of adverse event and safety reporting, as well as internal communications to ensure appropriate clinical follow-up.
• Prepares and responds to audit findings and coordinates corrective action plans (CAPA).
• Communicates on-going project status, potential issues, and timelines to investigators, peers and leadership as appropriate.
• Participates in Institute-wide meetings pertaining to area of responsibility (e.g. Section Meetings, Protocol Review, Tumor Board, clinic-based, etc.).
• Assists leadership team in seeking ways to reduce costs and improve processes and efficiency.
• Understands basic scientific methods, biological principles and medical terminology, knowledge of Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines, as well as applicable rules/regulations pertaining to research; knowledge of regulatory requirements of the Food and Drug Administration (FDA), Institutional Review Boards (IRB), and Human Subjects Protections (OHRP) pertaining to clinical research.

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 clinical trials.

Education, Experience and Certifications

Graduate of an Accredited School of Nursing. RN required. Bachelor's Degree required. BSN preferred. Current NC Board of Nursing License required. CPR certification required. Minimum of 3 years clinical trials experience with a pharmaceutical company, Contract Research Organization (CRO), research center or equivalent required; oncology experience strongly preferred. OCN certification preferred. Certification in clinical research (SoCRA CCRP, ACRP, RAPS, or similar) preferred.