Oncology Research Specialist Registered Nurse

Full-time position, benefits eligible, 40 hours per week.

About the Role

Assists with clinical, regulatory, business, and other documentation associated with oncology research projects and clinical trials within LCI.

Responsibilities

• Participates in study project start-up activity, working with the PI and others to initiate new research projects.
• Maintains protocol amendments, deviations, and informed consent changes for oncology research studies, ensuring all documentation is managed compliantly and maintained in an audit-ready manner.
• Maintains appropriate documentation (e.g., FDA Form 1572, CTSU documentation, IRB approval letters, ICFs) for assigned studies.
• Assists in maintenance of filing systems, data repositories, and systems.
• Monitors clinical trial compliance by reporting issues and problems appropriately.
• Obtains required documentation (forms, slides, reports, etc.) to assess patient eligibility for research studies.
• Contacts local research staff to confirm scheduling of tests/treatments required by protocol.
• Obtains and completes data for patients enrolled on clinical trials.
• Completes Case Report Forms (CRFs) with a high level of accuracy.
• Completes and resolves queries from sponsors.
• Prepares and submits information from patient charts and other source documents on appropriate data forms, flowsheets, or databases.
• Assists with inventory, ordering, organization, and distribution of supplies related to assigned trials, with critical focus on expiry management.
• Maintains regulatory binders for review at monitoring visits.
• Maintains patient shadow charts with appropriate source documentation.
• Completes registration for patient enrollment and maintains status in sponsor and LCI databases.
• Assists with the coordination of research monitor visits and audits; prepares appropriate data.
• Assists in the collection, preparation, and shipping of samples.
• Coordinates required protocol-related activities such as tests and treatments using CTMS.
• Assists in writing and updating Informed Consents with PI and team.
• Supports the clinical trial team to efficiently complete tasks including documentation/submissions, Serious Adverse Events (SAEs)/safety reports, FDA Form 1572, DARFs, ClinicalTrials.gov postings, etc.

Requirements

• Must hold a valid applicable state or South Carolina (as applicable) Board of Nursing license.
• Graduate of an accredited nursing program (ADN, RN) required; Bachelor's Degree in Nursing (BSN) or higher preferred.
• CPR certification required.
• Previous experience in a healthcare setting preferred, especially in cancer care and/or clinical research.
• Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred.

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.

Pay

Pay range: $38.20 - $57.30 per hour.

Benefits

• Comprehensive suite of Total Rewards including competitive compensation and generous retirement offerings.
• 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.
• Premium pay such as shift, on-call, and more based on the teammate's job.
• Incentive pay for select positions.
• Opportunity for annual increases based on performance.