Regulatory Coordinator
Company: Jobot
Location: Garden Grove
Posted on: June 25, 2022
Job Description:
This Jobot Job is hosted by: Mary LazarineAre you a fit? Easy
Apply now by clicking the "Apply Now" button and sending us your
resume.Salary: $25 - $28 per hourA bit about us:Be part of one of
the largest and fastest-growing clinical research companies in the
United States with potential internal growth and advancement.Work
alongside a successful and dynamic team conducting clinical trials
for new medications and treatment in various therapeutic areas not
limited to psychiatric, general health, and neurological phase I-IV
studies.Why join us?Great Compensation & Benefits!Job DetailsJOB
SUMMARYThe Regulatory Coordinator is responsible for the
facilitation of prompt submission of new protocols and amendments
to research regulatory oversight committees by preparing committee
applications and collecting documents for review. The regulatory
function is responsible for assisting with the organization and
implementation of regulatory research documents such as pre-study
activities, initiation, execution, and reporting on the status of
various research tasks. Reporting status includes but is not
limited to only initial IRB submissions, continuing review,
advertising materials, IND safety reports, SAE reports,
deviation/violation reports, amendments, and close-out of
studies.Essential Responsibilities and Duties:The Regulatory
Coordinator is responsible for all or part of these
areas:Daily:
- Develop and maintain a professional and educational
relationship with sponsors, CROs, monitors, investigators, and CNS
Network Staff.
- Maintain in-date regulatory documents and training records of
study staff and investigators in accordance with applicable
regulations.
- Update physician profiles of each investigator (CV, DEA
license, medical license, debarment, etc.).
- Maintain current investigator credentialing (i.e., CV, etc.),
current IRB roster for each study.
- Additional responsibilities may include working directly with
other research bases and/or sponsors.Post Site-Selection Activity
- Participate in required training and education programs.
- Provide guidance to junior personnel involved in the planning,
implementation, and evaluation of clinical studies.
- Assist in training new personnel.Initiation of StudyThe
Regulatory Department creates and maintains the regulatory bin in
accordance with the industry guidelines. Each section represents a
tab in the regulatory bin and should be standardized below for each
study. Most of the paperwork generated below calls for
communication between all four parties (sponsor, IRB, coordinator,
and regulatory) for each transaction. These activities will require
daily communication with coordinators and regular communication
with sponsors and the IRB on an as-needed basis.
- Current signed and dated CV and licensure (update at expiry
date for licenses)
- Protocol/Amendment Signature Page
- Protocol
- Amendments (if applicable)
- Investigator's Drug Brochure Signature Page (if
applicable)
- FDA Form 1572
- Financial Disclosure Statement
- IRB Investigator and/or Site Information Questionnaire
- IRB Correspondence
- Informed Consent
- IRB Membership Roster
- Sponsor Correspondence
- Site Signature Page/Declaration of
Authority/ResponsibilityStudy ExecutionVerify regulatory bin for
the study is complete and up to date for monitoring visits.
Documents may be updated periodically; this will necessitate
regular maintenance of the regulatory bin. This activity will
require daily communication with coordinators and regular
communication with sponsors and the IRB on an as-needed basis. Most
of the paperwork generated below calls for communication between
all four parties for each transaction (sponsor, IRB, coordinator,
regulatory).
- Sponsor Contact Information
- Protocol / Amendment Signature Page(s)
- Investigator Agreement
- Protocol (most current filed on top)o Current ProtocolThis job
description is not intended to be all-inclusive and may perform
other reasonably related duties as assignedby their direct manager
and/or supervisor as needed.Rev. 04/47/2022 QA FINAL SGC 27APR2022
Regulatory Coordinator --- Page 3 of 4Employee Initial _____o Any /
All Previous Versions of Protocol
- Amendments
- Confidentiality Agreement
- FDA 1572 Formo Current Version of FDA 1572 Formo All Previous
Versions of FDA 1572 Form
- CV and Licensureo Current CV for Principal Investigatoro
Current Medical License and DEA License for PIo Current CV for all
Sub-Investigator's Listed in Box #6 of FDA 1572o Current Licensure
for all Sub-Investigator's Listed in Box #6 of FDA 1572---
Financial Disclosure for Principal Investigator and all
Sub-Investigators--- IRB Correspondence--- IRB Membership List---
All Correspondence to & from IRB / Investigator, Including All
Approvals &Acknowledgements--- Informed Consent--- Informed
Consent Log--- Sponsor Correspondence--- Study Personnel Signature
Log--- Staff Training Records--- Screening / Enrollment Logs---
Patient Identification Listo Not to be provided to the sponsor or
monitor, as this is PHI and is for authorized personnel onlyo
Note-to-File for location if not kept in regulatory bin.---
Monitoring Log--- IND Safety Reports--- SAE Reports--- Lab
Certification & Normal Ranges--- CAP--- CLIA--- Normal Ranges and
Values--- CV for Lab Director--- Investigational Drug Brochure /
Package Inserts--- Investigational Drug Brochure Signature Page (if
applicable)--- FDA Regulations & ICH Guidelineso FDA Regulations:
21 CRF Parts 50, 54, 56 & 312o ICH Guideline: E6 Good Clinical
PracticeMinimum QualificationsKnowledge:
- Working knowledge of clinical trials, Federal, State, Local
Regulation, IRB requirement, ICH-GCP, consent form, data
management, and protocol development.Skill:
- Two or more years of experience related to the management and
conduct of clinical trials.
- Demonstrated good business acumen with a sense of urgency and
excellent interpersonal and communication skills.
- Computer competency in Microsoft programs: Words, Excel,
PowerPoint, etc.Ability:
- Demonstrated ability to prioritize workload to meet tight
deadlines and demands of a fast-paced
environment.Education/Licenses/Certifications/Other:
- Bachelor's degree in Human Resources, Business Administrative,
Organization Development or equivalent combination of education and
experience sufficient to successfully perform the job's essential
duties such as those listed above.Preferred Qualification: ---
Certification in Clinical Research.Work Environment and Physical
RequirementsThese physical demands are representative of the
physical requirements necessary for an employee to perform the
essential functions of the Regulatory Coordinator job
successfully.Reasonable accommodations can be made to enable
individuals with disabilities to perform the described essential
functions of the job.While performing the responsibilities of the
job, the employee is required to talk and hear. The employee is
often required to sit and use their hands and fingers to handle or
feel and manipulate keys on a keyboard.The employee is occasionally
required to stand, walk, reach with arms and hands, climb or
balance, and stoop, kneel, crouch, or crawl. Vision abilities
required in this job include close vision. May lift up to 25
lbs.Interested in hearing more? Easy Apply now by clicking the
"Apply Now" button.
Keywords: Jobot, Garden Grove , Regulatory Coordinator, Other , Garden Grove, California
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