Job Summary

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.
Essential Functions

• Fulfills the job responsibilities of the Oncology Research Specialist, and:
• 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.

Physical Requirements
Primarily works in an office setting. Requires full range of body motion; sitting for extensive periods of time; walking, standing, reading, and writing/keyboarding. Occasionally lifts and carries items weighing up to 35 pounds. Requires corrected vision and hearing within normal range. 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.
Education, Experience and Certifications

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. 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.

Specialty Area: Regulatory Affairs & Compliance

Additional Essential Functions

• Fulfills the job responsibilities of the Oncology Research Specialist – Regulatory Affairs & Compliance, and: 
• Provides regulatory submissions and manages regulatory documentation for clinical trial start-up, consent and/or protocol amendments, continuing review, closure to accrual, safety reporting, suspension, study termination and other information to reporting agencies and trial sponsors.
• Liaise with Principal Investigator, Sub-Investigators, study personnel, IRB, sponsor/CRO and other internal/external entities on clinical trial regulatory operations. 
• Conducts routine NCI research base/sponsor website reviews to identify regulatory updates and actions required. 
• Oversees timely regulatory submissions to meet project deadlines.
• Coordinates and prepares for audits with appropriate departments to address regulatory-related quality and compliance matters.
• Participates in sponsor study start-up and follow-up meetings as appropriate.
• Collaborates and ensures procedural compliance related to study conduct. 
• Assists in the development, improvement, and review of Standard Operating Procedures and guidelines to ensure procedural compliance. 
• Provides regulatory-related educational and technical assistance to research staff including orientation and mentoring of new research teammates.

Additional Physical Requirements

Primarily works in remote/home-based setting in the Charlotte regional area.

Additional Training and Certifications

• Regulatory knowledge of FDA/OHRP regulations, and more complex regulatory processes.
• Must speak and read/write clearly in English.