Oncology Research Specialist Registered Nurse - Atrium Health Levine Cancer Institute Clinical Trials
About The Position
This role involves assisting with clinical, regulatory, business, and other documentation associated with oncology research projects and clinical trials within the Atrium Health Levine Cancer Institute (LCI). The specialist will participate in study project start-up, maintain protocol amendments and deviations, and ensure all documentation is managed compliantly and maintained in an audit-ready manner. The position requires obtaining and completing data for enrolled patients, completing Case Report Forms (CRFs) with high accuracy, and resolving queries from sponsors. Additionally, the role supports the clinical trial team with various tasks including documentation, submissions, safety reports, and coordination of research monitor visits and audits. The specialist will also assist with the collection, preparation, and shipping of samples, and the coordination of protocol-related activities using the Clinical Trials Management System (CTMS).
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.
- Oncology experience strongly preferred.
- OCN certification 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
- Comprehensive suite of Total Rewards: benefits and well-being programs
- Competitive compensation
- Generous retirement offerings
- Programs that invest in your career development
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
