Top 32 Clinical documentation specialist Jobs in Fremont, Ca

Clinical Trials Regulatory Specialist 1
Stanford University —Stanford, CA
- Full-time
- Hybrid work
- Customer service
- Microsoft Office
- 3 years
3d
Medical Records Coder II/III - Correctional Health (Open & Promotional)
County of San Mateo —San Mateo, CA
- $93,704 - $134,784 a year
- Full-time
- Anatomy knowledge
- Mid-level
- Windows
- Retirement plan
Emergency Trauma Charger
Sutter Health —Castro Valley, CA
- $31.33 - $39.66 an hour
- 8 hour shift
- Nursing
- Anatomy knowledge
- Microsoft Excel
4d
CREDENTIALING SPECIALIST
RAVENSWOOD FAMILY HEALTH CENTER —East Palo Alto, CA
- $25 - $30 an hour
- Customer service
- Computer literacy
- Mid-level
11d
FSP CRA II - Alzheimer's Experience - US West
Thermo Fisher Scientific —California
- $88,600 - $132,000 a year
- Full-time
- RN License
- Writing skills
- English
- Commuter assistance
- Paid parental leave
14d
Neuroimaging Research Assistant
Stanford University —Stanford, CA
- $38.55 - $46.68 an hour
- Extended hours
- English
- Mid-level
- Databases
Research Specialist
RDE Logistics —Palo Alto, CA
- $37 - $44 an hour
- Full-time
- Mid-level
- Databases
- In-person
Quick Apply
SART Nurse - Extra Help (Open)
County of San Mateo —San Mateo, CA
- $25 - $55 an hour
- On call
- Nursing
- RN License
- Hospital
Electronic Health Record Analyst III - BID (Open & Promotional)
County of San Mateo —San Mateo, CA
- $146,120.00 - $182,582.40 a year
- Full-time
- Hybrid work
- Clinic experience
- Analysis skills
- Driving
- Retirement plan
Insurance benefit and billing specialist
Broberg Physical Therapy —San Jose, CA
- From $25 an hour
- Full-time
- Hybrid work
- Customer service
- Medical office experience
- HIPAA
Quick Apply
5d
Drug Utilization Management Specialist - Pharmacy 500P (Full-Time, 8-Hour Day Shifts)
Stanford Health Care —Palo Alto, CA
- $83.98 - $111.27 an hour
- 8 hour shift
- 5 years
- Analysis skills
- Supervising experience
Population Health Specialist
LIFELONG MEDICAL CARE —Oakland, CA
- $22 an hour
- Full-time
- Data entry
- Organizational skills
- In-person
- Paid holidays
- Health insurance
Quick Apply
8d
Per Diem Clinical Research Nurse - Home Visits
Science 37 —San Jose, CA
- $50 - $55 an hour
- Nights as needed
- Nursing
- RN License
- BLS Certification
Utilization Management - RN
Bickham Services Unlimited, LLC —Sunnyvale, CA
- Contract
- Nursing
- RN License
- Bachelor of Science
Quick Apply
Sr. Billing and Program Support Specialist
Hively —Oakland, CA
- $31.10 - $33.50 an hour
- Full-time
- Hybrid work
- Microsoft Word
- Customer service
- HIPAA
- Paid holidays
- Disability insurance
Quick Apply
Hospice Medical Billing Specialist
ALAMEDA CARE HOSPICE —Walnut Creek, CA
- $26 - $32 an hour
- Full-time
- HIPAA
- Mid-level
- High school diploma or GED
Quick Apply
Utilization Specialist - Full Time
San Jose Behavioral Health —San Jose, CA
- $33 - $50 an hour
- Full-time
- Acute care
- LMFT
- CPR Certification
Community Mental Health Nurse - Behavioral Health & Recovery Services (Open & Promotional)
County of San Mateo —San Mateo, CA
- $169,644.80 - $189,675.30 a year
- Full-time
- Spanish
- Nursing
- Psychiatry
- Retirement plan
Senior Clinical Trial Manager, Oncology
Eikon Therapeutics —Millbrae, CA
- $143,000 - $173,250 a year
- 6 years
- Office
- Master's degree
- AD&D insurance
- Paid holidays
Quick Apply
Medical Billing Specialist
Vascular Surgery —San Ramon, CA
- $25 - $29 an hour
- Overtime
- Surgery
- HIPAA
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
2d

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clinical documentation specialist jobs near fremont, ca

Clinical Trials Regulatory Specialist 1

Stanford University -
Stanford, CA

Apply Now

Job Details

Full-time
3 days ago

Qualifications

Database systems
Customer service
Microsoft Office

Full Job Description

The Department of Anesthesiology, Perioperative and Pain Medicine at Stanford Medicine is seeking a Clinical Trials Regulatory Specialist 1 to provide centralized regulatory support for a diverse portfolio of clinical research.

What the Role Entails

Supporting Study Start-Up and Regulatory Submissions. This position supports new clinical research studies from concept to activation by preparing and submitting regulatory packets. The role supports compliance with Stanford's Human Research Protection Program (HRPP) and applicable federal regulations while guiding research teams through Institutional Review Board (IRB) processes, from initial submission and responses to comments through final approval.

Providing Regulatory Guidance and Training. This position provides practical training and ongoing regulatory guidance to investigators and research staff throughout the study lifecycle. The specialist coordinates regular regulatory update meetings to keep teams informed of relevant requirements and process changes. As a department resource for principal investigators and study teams, the specialist helps navigate IRB inquiries, modifications, and submissions and applies relevant regulatory requirements to research involving drugs, medical devices, and artificial intelligence technologies.

Supporting Department-Wide Regulatory Compliance. The specialist monitors regulatory submissions across the department and follows up to support timely completion of continuing reviews and final reports. The role develops and maintains standard operating procedures (SOPs), quick-reference guides, and best-practice documents to support consistent regulatory practices. The specialist delivers quarterly training sessions to improve submission quality and efficiency, reduce avoidable delays, and keep department personnel informed of regulatory changes.

Supporting Compliance and Process Improvement. The role advises departmental leadership on operational and policy adjustments in response to evolving regulations and serves as a liaison and escalation contact for safety reporting and audit-related matters. The specialist helps develop systems and processes that support consistent and efficient regulatory compliance.

About the Department

Join a world-leading department at the forefront of medical innovation. Our comprehensive portfolio spans cutting-edge clinical trials and translational research, advanced patient care in anesthesiology, pain management, and critical care, plus health services research and medical education excellence.

Why Stanford Medicine?

Impact That Matters. At Stanford University School of Medicine, we're pioneering the future of Precision Health through leadership, diversity, and collaborative discovery. Every role contributes to our mission of improving health worldwide.

Invest in the Future. Stanford offers career development programs tailored to professional growth, competitive compensation that reflects market trends and expertise, and comprehensive benefits supporting financial stability and work-life balance. Our award-winning culture is rooted in excellence, innovation, collaboration, and lifelong learning.

Join Something Extraordinary. Be part of a team propelling medicine forward. At Stanford, the work is challenging, contributions matter, and careers thrive.

Core Duties :

Independently develop, draft and compile research protocol documents and all materials required for regulatory submissions in compliance with University and external policies.
Manage and oversee new study initiation process, including educating study staff and sponsors, resolving issues and providing regulatory guidance and support.
Facilitate and participate in committee meetings, ensure procedures are followed. Responsible for compiling, organizing, and storing all session documentation and communicating results as appropriate.
Revise submissions for identified problems and issues and resolve any procedural issues that might arise in order to ensure timely response; advise investigator on remedies and revisions.
Maintain regulatory documents, monitor and recommend improvements for tracking regulatory documents. May assist with registering and reporting of clinical trials, i.e. ClinicalTrials.gov.
Collaborate on development of standard operating procedures, trainings, and documentation. May participate in delivering trainings.
Stay current on federal, state, and local regulations regarding clinical research and communicate changes to study staff and recommend related changes to leadership.
May serve as primary liaison on safety issues and reporting procedures with the IRB, OSR, RMG or other internal organizations or committees.
May co-author committee responses to investigators, assure these are reviewed, signed by the Chairperson, and communicated promptly to the necessary parties.

Minimum Education and Experience

Bachelor’s degree and three years of related experience or a combination of education and relevant experience.

Knowledge, Skills and Abilities :

Excellent communication skills and superb attention to detail.
Experience with MS Office products and database applications required.
Excellent inter-personal skills and customer service focus is required.
Experience in clinical trials operations, knowledge of clinical trials regulatory requirements, or experience working with an IRB.
Knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice.
Strong writing skills.

Apply Now

Refine Your Search

clinical documentation specialist jobs in fremont, ca

Clinical Trials Regulatory Specialist 1

Medical Records Coder II/III - Correctional Health (Open & Promotional)

Emergency Trauma Charger

CREDENTIALING SPECIALIST

FSP CRA II - Alzheimer's Experience - US West

Neuroimaging Research Assistant

Research Specialist

SART Nurse - Extra Help (Open)

Electronic Health Record Analyst III - BID (Open & Promotional)

Insurance benefit and billing specialist

Drug Utilization Management Specialist - Pharmacy 500P (Full-Time, 8-Hour Day Shifts)

Population Health Specialist

Per Diem Clinical Research Nurse - Home Visits

Utilization Management - RN

Sr. Billing and Program Support Specialist

Hospice Medical Billing Specialist

Utilization Specialist - Full Time

Community Mental Health Nurse - Behavioral Health & Recovery Services (Open & Promotional)

Senior Clinical Trial Manager, Oncology

Medical Billing Specialist

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