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Regulatory Coord III_Study Activation

Company: Cedars-Sinai
Location: Beverly Hills
Posted on: August 3, 2022

Job Description:

**JOB SUMMARY:**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 plan 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.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.Maintainance of regulatory-related internal tracking databases and distribute evenly regulatory tasks within the assigned team.Compile regulatory-related metrics for use by senior management.Communicate to Program Managers, study research personnel and investigators relevant changes to regulatory processes.Other duties as assigned by senior management.In collaboration with the manager, responsible for performing staff recruitment, screening, interviewing, hiring, performance evaluations, and counseling activities for the Unit.Assist in the development of goals for direct reports to foster professional growth and complete annual performance reviews following the Human Resource (HR) procedures. In addition, routinely monitor and evaluate staff performance during the annual review period and provide constructive and meaningful assessments on their performance.Monitor regulatory staff workload intensity and track deadlines to ensure timely submission and/or completion and appropriate regulatory reporting and compliance. Promote design, development, implementation, and assessment of sustainable workflows/solutions that will support the compliant conduct of clinical trials.Contribute to the review of new studies and provide guidance relevant to study start-up, activation, management, and close-out requirements. Serve as the primary resource for Investigators and clinical research team on regulatory matters, including collaborating departments and external partners.Collaborate with senior clinical management teams to support audit-related activities and written responses, in addition to developing, implementing, and monitoring Corrective and Preventive Action Plans (CAPA).Facilitate and promote the ongoing improvement of clinical trial compliance and quality assurance through the communication of audit results and providing supplemental regulatory training. Resolve regulatory queries through close collaboration with auditors, monitors, Investigators, research personnel, and partners.Collaborates with scientific and clinical faculty, managers and sponsor representatives, other departments, vendors, regulatory agencies and staff in development of new processes, problem-solving and conflict resolution. Leverage technology, in collaboration with research senior leadership, to promote compliance, increase efficiency, and improve effectiveness by recommending, implementing, integrating, and/or optimizing electronic systems, software, and solutions.Kronos editing/Time off requestsLead bi-weekly regulatory meeting with Reg Core**Educational Requirements:** BA/BS degree.**Licenses:** ACRP/SoCRA (or equivalent) certification preferred.**Experience:** Five (5) years minimum of directly related experience, or equivalent combination of education and experience.**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.**Working Title:** Regulatory Coord III_Study Activation**Department:** SOCCI Clinical Research Office**Business Entity:** Academic / Research**Job Category:** ,Compliance/Quality,Compliance/Quality**Job Specialty:** Research Compliance**Position Type:** Full-time**Shift Length:** 8 hour shift**Shift Type:** DayCedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.

Keywords: Cedars-Sinai, Beverly Hills , Regulatory Coord III_Study Activation, Other , Beverly Hills, California

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