Oncology Research Specialist Registered Nurse

Advocate Health and Hospitals Corporation•Charlotte, NC

5d•Onsite

About The Position

This position assists with clinical, regulatory, business, and other documentation associated with oncology research projects/clinical trials within LCI. The specialist participates in study project start-up activities, working with the PI and others to initiate new research projects. They maintain protocol amendments, deviations, and informed consent changes regarding oncology research studies, ensuring all documentation is managed compliantly and maintained in an audit-ready manner. The role involves maintaining appropriate documentation (e.g., FDA Form 1572, CTSU documentation, IRB approval letters, ICFs) for assigned studies, and assisting in the maintenance of filing systems, data repositories, and systems. The specialist will also assist in monitoring clinical trial compliance by reporting issues and problems appropriately. They will obtain required documentation to assess patient eligibility for research studies, contact local research staff to confirm scheduling of tests/treatments, and obtain and complete data for patients enrolled on clinical trials. This includes completing Case Report Forms (CRFs) with high accuracy, completing/resolving queries from sponsors, and preparing/submitting information from patient charts and other source documents on appropriate data forms/flowsheets/databases. The role also involves assisting with inventory, ordering, organization, and distribution of supplies related to assigned trials, maintaining supply inventory with a focus on expiry management, and maintaining the regulatory binder and patient shadow charts. Registration for patient enrollment and status maintenance in sponsor and LCI databases will be handled by this role. Additionally, the specialist will assist with coordinating research monitor visits and audits, preparing appropriate data, collecting, preparing, and shipping samples, and coordinating required protocol-related activities. They will also assist in writing/updating Informed Consents with the PI and team, and support the clinical trial team in completing tasks including documentation/submissions, Serious Adverse Events (SAEs)/safety reports, FDA Form 1572, DARFs, and ClinicalTrials.gov postings.

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.
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.

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

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