Oncology Research Specialist Registered Nurse - Atrium Health Levine Cancer Institute Clinical Trial

About the role

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.

Responsibilities

• 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.
• Maintains filing systems, data repositories and systems.
• Maintains 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.
• Aids in the preparation and submission of information from patient's chart and other source documents on appropriate data forms/flowsheets/databases.
• 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.
• 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 cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred. Oncology experience strongly preferred. OCN certification preferred. Previous experience in a healthcare setting preferred, especially cancer care and/or clinical research.

Qualifications

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 cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred. Oncology experience strongly preferred. OCN certification preferred. Previous experience in a healthcare setting preferred, especially cancer care and/or clinical research.

Skills

Strong organizational and communication skills. Proficiency in Microsoft Office applications. Ability to manage multiple tasks simultaneously. Knowledge of clinical research protocols and regulations.

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.

Pay

$38.20 - $57.30

Schedule

M-F, 8am-5pm