Job Description

Overview

Job Summary

Conducts and develops 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 Coordinator, and:
• Assists Principal Investigator and team in evaluating feasibility of research studies.
• Develops study budget in collaboration with team.
• Coordinates documentation for regulatory requirements.
• Coordinates trial-related activity of patients on protocols.
• Coordinates, follows, and evaluates patient participation in clinical trials to ensure compliance with the protocol.
• Coordinates protocol-specific clinical tasks including patient assessment, eligibility screening, symptom management, toxicity assessment, and monitoring of responses.
• Coordinates protocol-specific scheduling of tests and specimen collection across LCI locations.
• Monitors and reports significant study events including adverse events and protocol amendments, activity, status, and closures.
• Performs required study procedures, collects data, analyzes data and makes decisions regarding the clinical research study conduct, including initial screening, assessment, care, reassessment and modification of care in consultation with PI and team.
• Assists in data analysis and drafting of clinical study reports.
• Develops, updates and/or implements standard operating procedures (SOPs).
• Serves as a team leader.
• Serves as the key resource for Principal Investigator, physicians and research team and acts as the primary liaison with sponsors to facilitate study initiation, execution and termination.
• Ensures accurate and timely data collection, submission, and query resolution.
• Coordinates protocol-level documentation to ensure regulatory and institutional compliance.
• Educates patients and families about research studies, treatments, side effects and follow-up, as appropriate.
• Coordinates protocol activities across Levine Cancer Institute.
• Collaborates with investigators through attendance at Section meetings, conferences, and other meetings.
• Perform daily targeted and random research record reviews for accuracy and completeness
• Participate in Quality Control (QC) activities in preparation for National Clinical Trials Network (NCTN) and Sponsor Audits and FDA Inspections
• Assist with developing Corrective and Preventive Action (CAPA) Plans

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 3 years of clinical research experience with a pharmaceutical company or Contract Research Organization or equivalent experience required; or Master\'s Degree and 2 years of clinical research experience with a pharmaceutical company or Contract Research Organization or equivalent experience required; or a minimum of 6 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 preferred, especially cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred. Supervisory experience preferred.

Atrium Health