Oncology Research Specialist Registered Nurse

American Addiction Centers • Charlotte, NC

22h • $38 - $57 • Onsite

About The Position

This full-time position is responsible for assisting with clinical, regulatory, business, and other documentation associated with oncology research projects/clinical trials within LCI. The role involves participating in study project start-up, maintaining protocol amendments and deviations, and ensuring all documentation is managed compliantly and maintained in an audit-ready manner. The specialist will also maintain appropriate documentation for assigned studies, assist in maintenance of filing systems and data repositories, and monitor clinical trial compliance.

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.
• CPR certification required.

Nice To Haves

• Bachelor's Degree in Nursing (BSN), or higher, preferred.
• Previous experience in a healthcare setting preferred, especially cancer care and/or clinical research.
• Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred.

Responsibilities

• Assists with clinical, regulatory, business, and other documentation associated with oncology research projects/clinical trials within LCI.
• Participates in the study project start-up activity, working with the PI and others to initiate new research projects.
• Maintains protocol amendments, deviations, and informed consent changes regarding oncology research studies, assuring all documentation is managed compliantly and maintained in an audit-ready manner.
• Maintains appropriate documentation, (i.e. FDA Form 1572, CTSU documentation, IRB approval letters, ICFs, etc.) for assigned studies.
• Assists in maintenance of filing systems, data repositories and systems.
• Assists in the monitoring of 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 trial.
• Completes Case Report Forms (CRFs) maintaining high level of accuracy.
• Completes/resolves queries from sponsors.
• Obtains required forms, slides, reports, and other information needed to assess patient eligibility.
• Prepares and submits information from patient's chart and other source documents on appropriate data forms/flowsheets/databases.
• Assists with inventory, ordering, organization and distribution of supplies related to assigned trials.
• Maintains supply inventory with critical focus on expiry management.
• Maintains regulatory binder 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.
• Assists with the coordination of required protocol-related activities such as tests and treatments using CTMS.
• Assists in writing/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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree