Regulatory Coord III_Study Activation
Company: Cedars-Sinai
Location: Beverly Hills
Posted on: August 3, 2022
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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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