Do you have a passion for the highest clinical quality and patient happiness? Would you like to use your expertise with an organization known nationally for excellence in cancer treatment, research and education? We would be happy to hear from you! Please consider the following exciting opportunity with one of the most outstanding and dynamic places to work in the medical field as your next career move.

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The Regulatory Coordinator II submits continuations, amendments, responds to questions, generates reports, and maintains files research files and documentation involving the regulatory requirements for the study/clinical trial. Duties this position will cover are as follows; representing the Medical Center when meeting with pharmaceutical companies, attending weekly team meetings, and working with other staff to ensure all regulatory documents and requirements are met and up-to-date. The incumbent will plan and coordinate strategies for improving efficiency, action plans to improve quality, and training and education of personnel. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

*This position is hybrid*

Primary Duties and Responsibilities:

• Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC.
• Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies.
• Responds to all questions from the IRB or IACUC related to the regulatory aspects of the study.
• Completes forms and generates all reports necessary to policies/requirements.
• Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials.
• Meets with monitors from pharmaceutical companies and represents the Medical Center during these meetings.
• Works closely with the clinical trial coordinator, research staff, and investigators to make sure all regulatory documents for the research studies are up-to-date.
• Attends weekly research team meetings and updates staff and investigators on the status of regulatory submission and amendments.
• May provide training and education of other personnel.
• May participate in centralized activities of the department or institution.
• May plan and coordinate strategies to improve existing standard operating procedures related to regulatory affairs.
• May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Participates in required training and education programs.

Qualifications:

• Bachelor's degree, required.
• Three (3) years minimum of directly related experience.
• Specialty research certification, preferred.

Physical Demands:

Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.