Top 1186 Regulatory specialist Jobs in Long Beach, Ca

Clinical Research Regulatory Specialist
USC —Los Angeles, CA
- $75,968.95 - $81,000.00 a year
- HIPAA
- Mid-level
- Administrative experience
14d
Sr Regulatory Affairs Specialist
Masimo —Irvine, CA
- $85,000 - $130,000 a year
- Full-time
- Microsoft Outlook
- Computer literacy
- Mid-level
- Paid parental leave
- AD&D insurance
Regulatory Specialist
Westcliff University —Irvine, CA
- $75,000 a year
- Full-time
- Research
- Mid-level
- Master's degree
Quick Apply
Customs Specialist
C.H. Robinson —Long Beach, CA
- $21.76 - $45.96 an hour
- Full-time
- Hybrid work
- Background check
- Mid-level
- Office
- Paid parental leave
- Health savings account
4d
Environmental Health Specialist II
County of Orange —Santa Ana, CA
- $78,291.20 - $105,518.40 a year
- Full-time
- Customer service
- Word processing
- Mid-level
Program Analyst (Public Records Specialist)
The State Bar of California —Los Angeles, CA
- $92,960 - $123,943 a year
- Full-time
- Hybrid work
- Word processing
- Writing skills
- Mid-level
Quick Apply
Entry Level Admin Specialist
Vivant Talent —Huntington Beach, CA
- $26 - $30 an hour
- Full-time
- Administrative experience
- Bachelor's degree
- Organizational skills
Quick Apply
Gastroenterology Physician
Emanate Health Medical Group —West Covina, CA
- $495,000 - $550,000 a year
- Full-time
- Background check
- Medicine
- Doctoral degree
- Health savings account
- Loan repayment program
Quick Apply
QUALITY IMPROVEMENT/QUALITY ASSURANCE (QI/QA) SPECIALIST
Nhan Hoa Comprehensive Health Care Clinic —Garden Grove, CA
- $31 - $36 an hour
- Full-time
- 3 years
- Bachelor's degree
- Travel
- AD&D insurance
- Health insurance
Quick Apply
Sr. Regulatory Affairs Specialist
Prismatik Dentalcraft —Irvine, CA
- $86,000 - $120,000 a year
- Full-time
- Microsoft Outlook
- 5 years
- Research
- Health insurance
- Dental insurance
Quick Apply
Physical Therapist - PRN
Meadow Creek Post-Acute —Paramount, CA
- $50 - $55 an hour
- Per diem
- CPR Certification
- Skilled nursing facility
- Current TB test
Quick Apply
Senior Traffic Analyst
Aspen Environmental Group —California
- $115,000 - $145,000 a year
- Email
- Remote
- Microsoft Excel
- Data analysis skills
- 11+ years
Quick Apply
Mortgage Customer Service Specialist
Consolidated Analytics —Los Angeles, CA
- $40 - $60 an hour
- Temporary
- 5 years
- Office
- In-person
Quick Apply
Wire Client Support Specialist
MidFirst Bank —Los Angeles, CA
- $22 - $29 an hour
- Background check
- Microsoft Excel
- Microsoft Outlook
- Paid holidays
- Health insurance
5d
FIELD ARCHAEOLOGISTS - (Southern California)
SummitWest Environmental —California
- $27 - $32 an hour
- Part-time
- Microsoft Word
- Background check
- Clean driving record
- Health insurance
- Dental insurance
Quick Apply
BESS Field Service Specialist
OTEK Group Inc., —Los Angeles, CA
- $30 - $45 an hour
- Full-time
- English
- Mid-level
- High school diploma or GED
- Health insurance
- Dental insurance
Quick Apply
4d
Speech Therapist (SLP)
The Beach Post-Acute —Long Beach, CA
- $59 - $65 an hour
- Part-time
- CPR Certification
- Skilled nursing facility
- BLS Certification
Quick Apply
Affordable Housing/Tax Credit Property Manager / Community Manager
Western National Property Management —Stanton, CA
- $27 an hour
- Microsoft Excel
- Microsoft Outlook
- Customer service
- Health insurance
- 401(k)
Quick Apply
Associate Veterinarian
Petco —Irvine, CA
- $87,700 - $186,100 a year
- Full-time
- Fair chance
- Computer skills
- In-person
- Health insurance
- 401(k)
Audit Specialist
EverTrust Bank —City of Industry, CA
- $72,000 - $95,000 a year
- Full-time
- Data analysis skills
- Research
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
1d

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Clinical Research Regulatory Specialist

USC -
Los Angeles, CA

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Job Details

$75,968.95 - $81,000.00 a year
14 days ago

Qualifications

FDA submissions
Slack
Investigational new drug (IND) applications
Administrative experience
ICH guidelines
Video conferencing software
Content development
Collaborative technology platforms
Regulatory submission editing and review
Computer skills
Instructional materials development
Clinical quality assurance standards
Project stakeholder communication
Office experience

Full Job Description

The University of Southern California (USC), founded in 1880, is the largest private employer in the City of Los Angeles. As an employee of USC, you will be a part of a world-class research university and a member of the "Trojan Family," which is comprised of the faculty, students and staff that make the university what it is.

Learns and masters the creation, initiation, development, and revision of protocols, informed consents, case report forms, and other study and clinical research documentation to support principal investigators and quality assurance systems for the Clinical Investigations Support Office. Provides regulatory affairs support, coordinating or performing a wide variety of administrative and data management activities for CISO functions and research project goals. Helps prepare and conduct high-quality compliance reviews, including close-out and reporting. Updates all databases, and regulatory binders with information pertinent to studying milestone progress. Maintains communication, attends meetings, and answers questions from all involved parties including regulatory bodies, pharmaceutical companies, principal investigators and colleagues.

JOB ACCOUNTABILITIES:

Learns and masters the creation, initiation, development, and revision of protocols, informed consents, case report forms, and other study and clinical research documentation to support principal investigators and quality assurance systems for the Clinical Investigations Support Office. Submits protocols and supporting documents to internal and external regulatory bodies (i.e. Institutional Review Board), ensuring trials are consistent with approved proposals to open new studies.
Provides regulatory affairs support, coordinating or performing a wide variety of administrative and data management activities for CISO functions and research project goals. Manages and maintains CISO electronic regulatory files, including staff resumes, licenses, training certificates, equipment receipts, investigation logs, etc. Reviews documentation as needed to support regulatory filings, and maintains research files and documentation required by regulations.
Works with senior team members to support and facilitate clinical research. Helps prepare and conduct high-quality compliance reviews, including close-out and reporting. Interacting with research investigators and staff throughout the process, from helping activate study and research trials to escalating problems and issues, as needed. Provides support and clinical-specific training to staff, maintaining and improving quality assurance training and development programs as needed.
Updates all databases, and regulatory binders with information pertinent to studying milestone progress, including but not limited to: clinical trial management systems, IRB databases, internal and external spreadsheets, and study electronic systems.
Ensures compliance with all applicable local, state, and federal regulations, statutes, and laws, and with agencies including the IRB and Federal Drug Administration (FDA). Maintains compliance with Good Clinical Practice (GCP) guidelines, patient confidentiality (HIPAA) and any other applicable laws.
Maintains communication, attends meetings, and answers questions from all involved parties including regulatory bodies (i.e. IRB), pharmaceutical companies (including monitors), principal investigators and colleagues. Works with clinical trial coordinators, research staff and investigators to further communications, helping remove obstacles impeding trial progress.
Participates in KSOM centralized activities to support and promote research regulatory requirements. Coordinates with and assists other CISO staff and departments with educational efforts, helping ensure highest quality research and protection of human subjects. Identifies compliance training and educational needs, coordinates the reporting of serious adverse events and protocol deviations, and proposes, completes, and submits amendments to protocols and trial forms and documentation, as needed.
Performs other related duties as assigned or requested. The university reserves the right to add or change duties at any time.

The annual budgeted salary range for this position is $75,968.95 to $81,000. When extending an offer of employment, the University of Southern California considers factors such as, but not limited to, the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, internal peer equity, federal, state and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.

Minimum Education: Bachelor's degree Addtional Education Requirements Combined experience/education as substitute for minimum education Minimum Experience: 2 years Addtional Experience Requirements Combined experience/education as substitute for minimum work experience Minimum Skills: Experience in clinical research compliance, regulatory research and/or operations in the academic or private sector. Experience with submissions to the Institutional Review Board and/or the Federal Drug Administration for Investigational Drugs and Devices (IND/IDE). Knowledgeable of Informational Conference on Harmonization-Good Clinical Practice (ICHGCP), Department of Health and Human Services (DHHS), Office of Human Research Protections (OHRP) and FDA regulations and procedures. Ability to evaluate the risks and benefits of different solutions, and proven problem-solving and decision-making skills to uncover causes of problems. Exemplary organization skills and attention to detail. Proven ability to interpret, analyze, and apply pertinent policies, procedures, regulations, and requirements. Deft interpersonal and diplomatic skills for communicating tactfully with all levels of staff and varied individuals and groups. Demonstrated experience developing communication plans, instructional materials and related content. Experience with office management communication software/tools (e.g., Google suite, Slack, Skype). Preferred Education: Bachelor's degree Preferred Experience: 3 years in clinical research compliance, regulatory research and/or operations in the academic or private sector Preferred Skills: Extensive experience in compliance oversight, coordination, monitoring, and/or auditing of clinical research studies and trials. Advanced knowledge of regulations governing human research.

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Refine Your Search

regulatory specialist jobs in long beach, ca

Clinical Research Regulatory Specialist

Sr Regulatory Affairs Specialist

Regulatory Specialist

Customs Specialist

Environmental Health Specialist II

Program Analyst (Public Records Specialist)

Entry Level Admin Specialist

Gastroenterology Physician

QUALITY IMPROVEMENT/QUALITY ASSURANCE (QI/QA) SPECIALIST

Sr. Regulatory Affairs Specialist

Physical Therapist - PRN

Senior Traffic Analyst

Mortgage Customer Service Specialist

Wire Client Support Specialist

FIELD ARCHAEOLOGISTS - (Southern California)

BESS Field Service Specialist

Speech Therapist (SLP)

Affordable Housing/Tax Credit Property Manager / Community Manager

Associate Veterinarian

Audit Specialist

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