Oncology Research Consultant- RN – Atrium Health LCI Full Time

Summary:

The Oncology Research Consultant- RN at Atrium Health LCI, a remote role in Charlotte, NC, oversees clinical trials for the Levine Cancer Institute. Atrium Health, serving since 1940, operates over 40 hospitals and 900 care locations, focusing on quality care and innovation. This position manages research, regulatory compliance, and patient coordination to advance cancer care.

Responsibilities:

• Competently fulfills the job responsibilities of the Oncology Research Coordinator.
• 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.
• Acting on behalf of the sponsor for Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AHWFBCCC), facilitates the completion of Investigator-Initiated Research (IIR) project development in collaboration with the Principal Investigator, Biostatistics, QA Monitoring, Pharmacy, Regulatory, Clinical and Data Project Management, Finance, Contracts, external funding entities and other key sponsor stakeholders.
• Edits sections of IIR protocols after first draft is completed.
• Writes informed consent forms for IIR protocols.
• Writes operational manuals for IIR protocols, in collaboration with stakeholders.
• Manages questionnaires/surveys (creation and/or obtaining permissions, translation, etc) for use in IIR projects.
• Facilitates protocol development meetings.
• Serves as the key project contact for external funding entities during the development phase.
• Coordinates stakeholder review of external funder/vendor contract drafts in collaboration with Contracts.
• Coordinates and facilitates Site Initiation Visit training for IRB-approved IIR projects.
• Collaborates with the Regulatory and Compliance team on IRB/FDA submissions and review.
• Ensures relevant IIR documents are maintained in the regulatory binder.
• Facilitates IIR protocol amendments in collaboration with key stakeholders.
• Coordinates and leads applicable sponsor-led meetings with key stakeholders.
• Prepares agendas and minutes for IIR study team meetings.
• Reviews and assesses IIR protocol questions from study conduct sites and provides appropriate feedback or triaging.
• Assists with/facilitates amendments to LCI-sponsored clinical trials.
• Ensures contractual requirements with external collaborators are being met; writes and sends progress reports on IIR projects per funder requirements.
• Facilitates completion of Data and Safety Monitoring Committee reports for IIR clinical trials.
• Reviews, queries, and reports expedited safety event and deviation reports received from study conduct sites on IIR protocols.
• Creates and conducts applicable Site Initiation Visit and amendment training for study conduct sites.
• Assists in the development, improvement and review of Standard Operating Procedures and processes.
• Provides educational and technical assistance to new IIR teammates including orientation and mentoring of new IIR teammates.

Requirements:

• 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.
• Ability to review and understand all aspects of a clinical research protocol.
• Experience in serious adverse event reporting.
• Clinical experience in Oncology preferred.
• 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.
• 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.

Benefits:

• Paid Time Off programs.
• Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability.
• Flexible Spending Accounts for eligible health care and dependent care expenses.
• Family benefits such as adoption assistance and paid parental leave.
• Defined contribution retirement plans with employer match and other financial wellness programs.
• Educational Assistance Program.