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

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. 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.

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.
• Assists in maintenance of filing systems, data repositories and systems.
• Maintains regulatory binder for review at monitoring visits.
• Completes Case Report Forms (CRFs) maintaining high level of accuracy.
• Completes/resolves queries from sponsors.
• 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.
• Prepares and submits 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 patient shadow charts with appropriate source documentation.
• Completes registration for patient enrollment and maintains status in sponsor and LCI databases.
• Aids in the coordination of research monitor visits and audits; prepares appropriate data.
• Aids in the collection, preparation and shipping of samples.
• Aids in the coordination of required protocol-related activities such as tests and treatments using CTMS.
• Aids 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.

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 attention to detail skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Proficient in Microsoft Office applications.
• Knowledge of clinical research protocols and regulations.
• Experience with electronic health records and data management systems.

Benefits

Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more – so you can live fully at and away from work, including:

• Compensation Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training.
• Premium pay such as shift, on call, and more based on a teammate's job.
• Incentive pay for select positions.
• Opportunity for annual increases based on performance.
• Benefits and More 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.
• Education Assistance Program.

Pay

$38.20 - $57.30

Schedule

M-F, 8am-5pm