Oncology Research Coordinator, Levine Cancer Center

American Addiction Centers • Charlotte, NC

2d • $29 - $43 • Onsite

About The Position

Coordinates the clinical, regulatory, business, and other research- related activities and documentation for clinical trials conducted, follows industry standards and applicable regulations including FDA/OHRP guidance, GCP and ICH. This position is responsible for developing and managing the Myeloma Oncology REDCap database for Levine Cancer Institute. This database provides prospective and retrospective data on Myeloma oncology patients seen at LCI. The data is used for clinical and research projects which generate conference presentations, manuscripts, and grant proposals.

Requirements

• Bachelor's Degree and 1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or Master's Degree and 0-1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or a minimum of 3 years clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required with no degree.
• 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

• Health/Science degree 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

• Coordinates the clinical, regulatory, business, and other research- related activities and documentation for clinical trials conducted, follows industry standards and applicable regulations including FDA/OHRP guidance, GCP and ICH.
• Develops and manages the Myeloma Oncology REDCap database for Levine Cancer Institute.
• Coordinates clinical and regulatory document submissions for clinical trial start-up, consent development and amendment, protocol amendment, continuing review, closure to accrual, action letter, suspension, termination and other reportable regulatory information.
• Assesses patient eligibility through chart reviews and patient/family interviews.
• Assists in providing patient education regarding the nature of their disease and the benefits/risks of participating in a clinical drug trial.
• Collaborates with regulatory team, Principal Investigator, Sub-Investigators, study personnel, IRB, sponsor/CRO/monitor and other internal/external customers; coordinates documentation/submissions.
• Conducts routine NCI research base/sponsor website reviews to identify regulatory updates and actions required.
• Presents and obtains patient informed consent.
• Coordinates accurate data collection and record keeping by reviewing documents and processes for quality assurance and ensures timely and accurate submission of data.
• Coordinates and prepares for internal and external audits.
• Participates in sponsor study start-up and follow-up meetings as appropriate.
• Develops study calendars.
• Collaborates on billing and financial activity with Research Finance (budgets and billing compliance).
• Coordinates scheduling of patient visits, labs, and diagnostic procedures.
• Coordinates drug shipments, storage, and accountability with IDS/Pharmacy.
• Assists in the development, improvement and review of Standard Operating Procedures and processes.
• Provides educational and technical assistance to research staff including orientation and mentoring of new research teammates.

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