Top 52 clinical study manager Jobs in irvine ca

Regulatory Specialist - Clinical Research
CenExel Clinical Research —Anaheim, CA
- $30 - $35 an hour
- Overtime
- Psychiatry
- Writing skills
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Clinical Study Manager
Cordis —Irvine, CA
- $114,950 - $165,000 a year
- Full-time
- Remote
- Nursing
- 8 years
- Analysis skills
Clinical Data Manager
ClinDatrix —Irvine, CA
- Full-time
- Writing skills
- Mid-level
- Bachelor's degree
Clinical Trial Coordinator
BALT Group —Irvine, CA
- $80,000 - $85,000 a year
- Nursing
- Writing skills
- Mid-level
Quick Apply
Project Manager, Clinical Research (Remote)
MicroVention, Inc. —Aliso Viejo, CA
- $116,706 - $145,882 a year
- Remote
- Microsoft Outlook
- Supervising experience
- Bachelor's degree
Clinical Trial Assistant (Invoicing) - Remote
Cordis —Irvine, CA
- $61,050 - $77,000 a year
- Full-time
- English
- Mid-level
- Bachelor's degree
Research Data Coordinator - Hybrid
University of California, Irvine —Orange, CA
- $35.77 - $58.96 an hour
- Full-time
- Background check
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Retirement plan
Clinical Project Manager
ClinDatrix —Irvine, CA
- Full-time
- Mid-level
- Bachelor's degree
- Doctor of Philosophy
Asst. Clinical Research Coordinator - Hybrid
University of California, Irvine —Orange, CA
- $29.63 - $48.81 an hour
- Full-time
- Background check
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Retirement plan
Specialist, Clinical Compliance
JENAVALVE TECHNOLOGY INC —Irvine, CA
- $80,000 - $90,000 a year
- Full-time
- Microsoft Excel
- Mid-level
- Bachelor's degree
Quick Apply
5d
ASST. RESEARCH DATA COORDINATOR - HYBRID
University of California, Irvine —Orange, CA
- $27.40 - $45.13 an hour
- Full-time
- Remote
- Background check
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Retirement plan
Data Management Project Manager
ClinDatrix —Irvine, CA
- Full-time
- 5 years
- Office
- Bachelor's degree
Clinical Research Coordinator II: Digestive Health
Hoag Health System —Newport Beach, CA
- Full-time
- Mid-level
- Windows
- High school diploma or GED
Sr Clinical Research Associate (CRA)
Tarsus Pharmaceuticals —Irvine, CA
- $109,500 - $153,300 a year
- Hybrid work
- 5 years
- Office
- Bachelor's degree
- Paid holidays
- Dental insurance
Sr. Project Manager, Clinical Research (Remote)
MicroVention, Inc. —Aliso Viejo, CA
- $147,532 - $193,635 a year
- Remote
- Microsoft Outlook
- Master's degree
- Bachelor's degree
Associate II, Field Clinical Monitoring
MicroVention, Inc. —Aliso Viejo, CA
- $96,210 - $126,275 a year
- Microsoft Outlook
- Computer literacy
- Laboratory experience
Regulatory Affairs Coordinator
University of California, Irvine —Orange, CA
- $35.77 - $58.96 an hour
- Full-time
- Background check
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Retirement plan
Clinical Research Manager - Hybrid
University of California, Irvine —Irvine, CA
- $97,000 - $182,200 a year
- Full-time
- Background check
- 5 years
- Word processing
- Health insurance
- Retirement plan
Associate, Clinical Research
JENAVALVE TECHNOLOGY INC —Irvine, CA
- $75,000 a year
- Full-time
- Nursing
- English
- Mid-level
Quick Apply
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

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Regulatory Specialist - Clinical Research

CenExel Clinical Research -
Anaheim, CA

Quick Apply

Job Details

Full-time
$30 - $35 an hour

Benefits

Health insurance
Dental insurance
401(k)
Vision insurance

Qualifications

Clinical research
Writing skills
High school diploma or GED
Clinical research regulatory specialist experience
FDA regulations

Full Job Description

About Us:

Each of CenExel’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.

Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.

THIS IS NOT A REMOTE POSITION

Job Summary:

With moderate oversight the Regulatory Coordinator I is responsible for the preparation, organization and implementation of regulatory research documents such as pre-study activities, initiation, execution, and reporting on the various status of research tasks in accordance with FDA guidelines, ICH GCP and SOPs. Maintain regulatory documents in accordance with applicable regulations and coordinate required investigator and study staff training.

Schedule: Monday - Friday 08:00 am - 4:30 pm

Hourly Range: $30.00 - $35.00/hr (Depending on education, experience, and skillset)

Essential Responsibilities and Duties:

Collects, prepares, and submits documentation to various sponsors/CROs during study start-up, including: Submission documents/approval, Protocol amendments with respective signature pages, Informed consent documents, FDA form 1572, Lab normal result documents, financial disclosure forms, Delegation of authority logs, Licenses, Reports.
Logs (e.g., temperature logs, drug accountability logs, master subject logs, screening and enrollment logs, specimen logs, etc.)
Collects, prepares, and submits documentation to institutional review boards for all ongoing and new trials.
Serve as a liaison between the IRB, site, and investigator.
Obtain necessary signatures from investigators and staff.
Maintains and tracks current staff credentials (i.e., CV, certifications, etc.)
Maintains and distributes new and revised regulatory documents to applicable site staff and applicable corporate teams.
Refers necessary regulatory questions to Sr. Regulatory Coordinator, Regulatory Manager or Regional Regulatory Manager.
Maintains regulatory documents for ongoing trials, and ensures all appropriate regulatory documents are archived at the conclusion of the study.
Submits applicable subject facing documents for translations.
Maintains current Clinical Conductor Regulatory information.
Prepares appropriate reports for submission as required to the IRB including Serious Adverse Events (SAE’s), protocol deviations and other required reports.
Completes onboarding of new Investigators, including CV creation, obtaining medical license, and training documents.
Ensures the regulatory binder is ready for monitor review during monitor visits. Meets with monitor, as necessary.
Assists with regulatory inspections and sponsor audits as necessary.
Performs close-out duties including preparing the final report to the IRB and ensuring all original documents are filed in the regulatory binder. Ensures all appropriate regulatory documents are archived at the conclusion of the study.
Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.

Education/Experience/Skills:

Must be a high school graduate or have GED equivalency.
1+ years of regulatory experience in clinical research required
Demonstrated prioritization and organizational skills to efficiently and effectively, providing accurate information in a timely manner.
Ability to prioritize workload to meet demands of PI, coordinators, sponsors, and IRBs.
Ability to prioritize workload to meet demands of PI, coordinators, sponsors, and IRBs.
Demonstrated interpersonal skills to work with physicians, administrators, work colleagues, representatives from sponsors and others to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner.
Ability to understand work may be delegated by more than one person, depending on the individual needs of the clinical study and to carry out job responsibilities as assigned in a timely manner.
Computer skills using PC platform computers with proficiency in Excel and Word to enter data and generate correspondence accurately.
Ability to learn and become proficient in eRegulatory systems, IRB portals, vendor portals and sponsor portals.
A critical thinker with strong attention to detail and superb problem-solving abilities.
Must be able to effectively communicate verbally and in writing.

Working Conditions

Indoor, Office environment.
Essential physical requirements include sitting, typing, standing, and walking.
Lightly active position, occasional lifting of up to 20 pounds.
Reporting to work, as scheduled, is essential.
Ability to work overtime, weekends, and/or holidays as needed.
Ability to travel as needed.
Remote work arrangement depending on location.

CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Pay: $30.00 - $35.00 per hour

Expected hours: 40.0 per week

Benefits:

401(k)
Dental insurance
Health insurance
Vision insurance

Work Location: In person

Quick Apply

Refine Your Search

clinical study manager jobs in irvine ca

Regulatory Specialist - Clinical Research

Clinical Study Manager

Clinical Data Manager

Clinical Trial Coordinator

Project Manager, Clinical Research (Remote)

Clinical Trial Assistant (Invoicing) - Remote

Research Data Coordinator - Hybrid

Clinical Project Manager

Asst. Clinical Research Coordinator - Hybrid

Specialist, Clinical Compliance

ASST. RESEARCH DATA COORDINATOR - HYBRID

Data Management Project Manager

Clinical Research Coordinator II: Digestive Health

Sr Clinical Research Associate (CRA)

Sr. Project Manager, Clinical Research (Remote)

Associate II, Field Clinical Monitoring

Regulatory Affairs Coordinator

Clinical Research Manager - Hybrid

Associate, Clinical Research

Clinical Research Site Manager

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