The Regulatory Coordinator III will provide supervision of other regulatory staff. Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC. This role submits continuations, amendments, responds to questions, generates reports, and maintains research files and documentation involving the regulatory requirements for the study/clinical trial. Other duties include, 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. May plan and coordinate strategies for improving efficiency, action plans to improve quality, or 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).
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
Provides supervision of other regulatory staff.
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 comply with regulatory requirements and institutional policies.
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 assure that 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.
May be required to develop clinical trial budgets.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
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.
DEPARTMENT AND/OR UNIT SPECIFIC ESSENTIAL JOB RESPONSIBILITIES:
Coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) including communicating with ancillary committees, study team, contract research organizations, and sponsors.
Assist with training of all regulatory personnel with regards to regulatory compliance.
Act as a mentor for new employees and find ways to improve the department's mentorship program.
Work directly with senior management to examine opportunities for regulatory innovation and promote the use of novel approaches within the project team to resolve issues and problems.
Conduct regular quality review on enrolling studies on an on-going basis
Maintain of regulatory-related internal tracking databases and distribute evenly regulatory tasks within the assigned team.
Compile regulatory-related metrics for use by senior management.
Assist in the development of written work instructions and conducts training opportunities.
Communicate to study research personnel and investigators relevant changes to regulatory processes.
Participate in the audit response and CAPA processes to identify, recommend, and implement corrective and preventive actions for regulatory and other related processes with the guidance of senior leadership.
Verify that implemented corrective and preventive actions are suitable and effective by supporting implemented quality assurance (QA) & quality control (QC) checks on active clinical trials.
Other duties as assigned by senior management.
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BA/BS degree, required
ACRP/SoCRA (or equivalent) certification preferred.
Five (5) years minimum of directly related experience
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.
Working Title: Regulatory Coordinator III - Cancer Clinical Trials Office
Department: SOCCI Clinical Research Office
Business Entity: Academic / Research
City: Los Angeles
Job Category: Compliance/Quality
Job Specialty: Research Compliance
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day