Top 95 Clinical research associate Jobs in Orange County Ca

Clinical Research Associate
Diality —Irvine, CA
- $120,000 - $135,000 a year
- Full-time
- Nursing
- Up to 50% travel
- Writing skills
Quick Apply
Senior Clinical Research Associate
ClinDatrix —Irvine, CA
- Full-time
- Word processing
- Computer literacy
- Mid-level
Principal Clinical Research Analyst - Class III Medical Devices (EU MDR Clinical Affairs Expert)
BIOTRONIK —Tustin, CA
- $165,000 - $185,000 a year
- Online Application
- Hybrid work
- 7 years
- Office
- Bachelor's degree
- Health savings account
- Health insurance
Senior Clinical Research Coordinator
Ark Clinical Research —Fountain Valley, CA
- $35 - $40 an hour
- Full-time
- Spanish
- Nursing
- LVN
- Health insurance
- Dental insurance
Quick Apply
Clinical Research RN - Research Projects
Providence Health and Services —Orange, CA
- $54.05 - $83.90 an hour
- Full-time
- Nursing
- RN License
- Hospital
- Paid parental leave
- Paid holidays
14h
Clinical Research Specialist
Kelly Services —Irvine, CA
- $92,000 a year
- Full-time
- Nursing
- Bachelor of Science
- English
- Paid holidays
- Disability insurance
Quick Apply
Clinical Rater
Synapse Clinical Trials, Inc —Cerritos, CA
- $80,000 - $120,000 a year
- Weekends as needed
- Nursing
- Licensed Clinical Social Worker
- HIPAA
Quick Apply
8d
Senior Associate, Clinical Research
JENAVALVE TECHNOLOGY INC —Irvine, CA
- $95,000 a year
- Full-time
- Nursing
- English
- Mid-level
Quick Apply
Clinical Research Coordinator I, Oncology
CHOC Children's —Orange, CA
- $29.48 - $48.61 an hour
- Full-time
- Microsoft Excel
- Writing skills
- Children
Research Associate
Heluna Health —Santa Ana, CA
- $28.82 - $36.25 an hour
- Full-time
- Background check
- Microsoft Excel
- Microsoft Outlook
Clinical Research Coord II, Oncology
CHOC Children's —Orange, CA
- $30.94 - $51.05 an hour
- Full-time
- Microsoft Excel
- Hospital
- Writing skills
Research Data Coordinator - Hybrid
University of California, Irvine —Orange, CA
- $37.56 - $61.91 an hour
- Full-time
- Background check
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Retirement plan
Clinical Research Coordinator
University of California, Irvine —Orange, CA
- $37.56 - $61.91 an hour
- Weekends as needed
- Background check
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Retirement plan
Specialist, Clinical Safety (US Remote)
MicroVention, Inc. —Aliso Viejo, CA
- $105,067 - $131,333 a year
- Remote
- Medicine
- Microsoft Outlook
- Mid-level
Clinical Study Coord
City of Hope —Irvine, CA
- $44.90 - $69.60 an hour
- Full-time
- HIPAA
- Mid-level
- Bachelor's degree
12d
Clinical Research Site Manager
Knowledge Research Center —Orange, CA
- $110,000 - $120,000 a year
- Full-time
- Background check
- Pass drug screening
- US work authorization
Clinical Data Manager
ClinDatrix —Irvine, CA
- Full-time
- Writing skills
- Mid-level
- Bachelor's degree
Clinical Research Recruitment Coordinator
Irvine Clinical Research —Irvine, CA
- $25 an hour
- Full-time
- Hybrid work
- Public speaking
- Clinic
- Older adults
- Dental insurance
- Paid time off
Quick Apply
Senior Analyst, Clinical Operations
Edwards Lifesciences —Irvine, CA
- $92,000 - $130,000 a year
- Full-time
- Anatomy knowledge
- Analysis skills
- Bachelor's degree
Clinical Site Monitor
Adagio Medical —Laguna Hills, CA
- Travel
- Organizational skills
- 1 year

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Clinical Research Associate

Diality
Irvine, CA

Quick Apply

Job Details

Full-time
$120,000 - $135,000 a year

Qualifications

Writing skills
ICH guidelines
Bachelor's degree
Clinical quality assurance standards
FDA regulations

Full Job Description

Description:

Company & Job Overview:

The Clinical Research Associate (CRA) will support Clinical Operations in planning, coordinating, and executing Diality clinical trials in compliance with applicable regulations (e.g., FDA, ISO 14155, ICH-GCP). This position plays a key role in supporting research projects at Diality, combing responsibilities of site management and administrative trial support to ensure smooth and efficient study operations.

As applicable, the CRA position works closely with clinical sites, internal departments (e.g., medical affairs, field service, clinical operations, clinical training and support), and external partners (Contract Research Organization, vendors) to ensure the quality and integrity of clinical data while maintaining adherence to study timelines.

Responsibilities:

Clinical Trial Administration

Assist with trial start-up, including preparing and submitting regulatory and ethics documents, such as IRB/EC submissions, contracts, and site feasibility questionnaires.
Maintain and organize the Trial Master File (TMF) and ensure all essential documents are current, complete, and audit-ready.
Track and manage trial documentation, including but not limited to site contracts, investigator agreements, financial disclosure forms, and training records.
Monitor study progress by updating trackers and preparing study status reports for internal and external stakeholders.

Site Management & Communication:

Establish, Monitor and Control tasks required tasks for site start-up activities during clinical trials.
Facilitate Communication Plan for clinical trial sites, including communications for internal Diality support teams
Act as a point of contact for clinical trial sites regarding study-related questions and issues.
Assist in managing site readiness, including regulatory and ethics submissions as needed, contract negotiations, and training.
Monitor site performance and compliance with protocols, regulations, and study timelines.
Support site readiness by ensuring all required study materials, such as investigator site files and study binders, are prepared and distributed.
Assist in scheduling and coordinating investigator meetings, site initiation visits (SIVs), and other study-related activities

Regulatory Compliance & Documentation:

As needed, assist with timely and accurate submission of regulatory documents, including IRB/EC approvals and site files.
Assist in writing and reviewing protocols, informed consent forms (ICFs), and other study-related documents.

Clinical Monitoring:

Perform remote monitoring activities such as source data verification (SDV) and data entry checks.
Assist with monitoring safety reporting, adverse events (AEs), and serious adverse events (SAEs).
Support quality assurance efforts by identifying protocol deviations and ensuring corrective actions.

Study Support:

Participate in the development of study tools, training materials, and site binders.
Assist in vendor and contract management for study-related services (e.g., laboratories, CROs).
Track study metrics, such as patient recruitment, site enrollment, and data collection timelines.

General Support:

Schedule and organize internal and external meetings, including drafting meeting agendas and minutes.
Assist in the preparation of presentations to both internal and external stakeholders as needed.
Support audit and inspection readiness by ensuring proper documentation and compliance with company SOPs and regulatory guidelines.

Collaboration & Reporting:

Collaborate with other Diality cross-functional teams, including regulatory, quality to ensure study compliance.
Support data management activities with data cleaning and resolving queries as applicable.
Prepare regular study updates, reports, and presentations for internal stakeholders.

Requirements:

Required Skills & Abilities

Attention to detail and problem-solving skills to ensure data quality and compliance
Strong organizational and time management skills.
Excellent written and verbal communication abilities.
Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
Ability to work independently and collaboratively in a fast-paced environment.

Education & Experience

Bachelor’s degree in a life science, healthcare, or related field (e.g., biology, nursing, or biomedical engineering).
5+ years of clinical research experience at a Sponsor, preferably in medical devices. A combination of other relevant experience (e.g., site level/CRO research) may also apply.
Familiarity with clinical trial regulations, including FDA, ISO 14155, and ICH-GCP.
Previous experience in a medical device company or knowledge of device-specific regulatory pathways.
Experience with managing remote monitoring activities or decentralized clinical trials.
Nephrology experience is a plus.

Travel

This role is primarily office-based with occasional travel (up to 50%) to clinical sites and meetings as needed.

Quick Apply

Refine Your Search

clinical research associate jobs in orange county ca

Clinical Research Associate

Senior Clinical Research Associate

Principal Clinical Research Analyst - Class III Medical Devices (EU MDR Clinical Affairs Expert)

Senior Clinical Research Coordinator

Clinical Research RN - Research Projects

Clinical Research Specialist

Clinical Rater

Senior Associate, Clinical Research

Clinical Research Coordinator I, Oncology

Research Associate

Clinical Research Coord II, Oncology

Research Data Coordinator - Hybrid

Clinical Research Coordinator

Specialist, Clinical Safety (US Remote)

Clinical Study Coord

Clinical Research Site Manager

Clinical Data Manager

Clinical Research Recruitment Coordinator

Senior Analyst, Clinical Operations

Clinical Site Monitor

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