Regulatory Coordinator II (Remote Option)
Company: Cedars-Sinai
Location: Beverly Hills
Posted on: May 26, 2023
Job Description:
Highly qualified candidates, residing in California, Arizona,
Nevada, Oregon, Texas, Colorado, Minnesota, Florida, and Georgia,
will be considered for remote work. Those that reside outside of
these states will not be considered - 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. The Regulatory
Coordinator II 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 insure all regulatory documents and
requirements are met and up-to-date. -May 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). ESSENTIAL JOB 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 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:
- Independently responsible for regulatory management for high
performing/productive and/or emerging disease research groups (DRG)
with moderate to complex research designs and high volumes (i.e.
accrual, timelines etc.)
- Adheres to critical deadlines and target timelines.
- May actively participate in program building within disease
research group
- May lead assigned project improvement, optimization or
enhancements with direct oversight and guidance provided by
management team
- May participate in or lead other department initiatives as
assigned
- May provide training, mentorship and/or support to junior staff
to ensure adequate regulatory compliance and critically evaluate
incoming requests or issues
- Serves as liaison for Industry sponsors, clinical
coordination/nursing and investigators.
- Responsible for ensuring investigator regulatory files and
documents are accurate and complete.
- Assists in the preparation of and participates in clinical
trial educational reviews, monitoring visits (internal or external)
and compliance audits.
- Provides guidance, under supervision of Manager or designee, to
physicians and principal investigators, IBC, CPRMC, PRMC, DSMC, and
IRB in the interpretation of applicable regulations and guidelines,
to include but not limited to GCP, GLP, ICH, FDA, and NIH OBA
guidelines.
- Maintains professional growth and development through seminars,
workshops, and professional affiliations to keep abreast of latest
trends in the field of expertise. Educational Requirements:
- BA/BS degree
- ACRP/SoCRA/RAPs (or equivalent) certification preferred.
Experience:
- Three (3) years minimum of directly related experience, or
equivalent combination of education and experience. Working Title:
Regulatory Coordinator II (Remote Option)Department: SOCCI Clinical
Research OfficeBusiness Entity: Cedars-Sinai Medical CenterJob
Category: Compliance/QualityJob Specialty: Research
CompliancePosition Type: Full-timeShift Length: 8 hour shiftShift
Type: DayBase Pay:$64,800.00 - $110,000.00
Keywords: Cedars-Sinai, Beverly Hills , Regulatory Coordinator II (Remote Option), Other , Beverly Hills, California
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