Clinical research coordinator jobs in Yucaipa, CA - 172 jobs
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SQRL
Clinical research coordinator job in Covina, CA
Highlights
$70,000 - $79,000 annual salary based on experience
Great benefits including 401k w/match and 15 days PTO
Consistent schedule, no overnights or weekends
Work with cutting edge research trials and a great team
About Our Client
Our client is a fast growing site network that currently has over 30 sites and constantly expanding! They focus on diversity in their trials including therapeutic areas: oncology, cardiology, metabolic disorders, renal, CNS, pulmonology, and vaccines. Their sites conduct studies spanning Phases I-IV and they've been awarded for excellence in recruitment and recognized in the industry for retention, a best-in-class experience for patients and sponsors.
Responsibilities
As a CRC you will be a specialized research professional under the direction of the clinical Principal Investigator and Site Manager. While the PI and Site Manager are responsible for the overall design, conduct, and management of the clinical trial, you support, facilitate, and coordinate the daily clinical trial activities and play a critical role in the conduct of the study including supporting patients throughout the clinical trial process!
Conduct procedures such as vital signs, blood draws, EKGs, and scans.
Patient recruitment, enrollment, scheduling, and consent
Lab procedures and shipments
Maintain GCP and follow protocols
Data management in EDC systems
Overall coordination of the study from start up to close out
Qualifications:
2+ years of experience working as a CRC on sponsor backed clinical trials
Phlebotomy and lab processing experience (ability to perform without supervision)
Ability to work on site M-F on site (there is no remote or hybrid days)
$70k-79k yearly 1d ago
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Clinical Research Manager - JJMT EP
6120-Janssen Scientific Affairs Legal Entity
Clinical research coordinator job in Irvine, CA
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Clinical Development & Research - Non-MD
Job Category:
People Leader
All Job Posting Locations:
Irvine, California, United States of America
Job Description:
Johnson & Johnson MedTech - Electrophysiology division is currently seeking a ClinicalResearch Manager. The role's preferred location is Irvine, California however we are open to remote candidates within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at *******************/.
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech
Summary:
Under limited supervision, this ClinicalResearch Manager will provide leadership to a team of ClinicalResearch Leaders (CRLs) and ClinicalResearch Specialists (CRSs) and ensure the successful performance and delivery of project deliverables, on time with high quality. The ClinicalResearch Manager will be responsible for encouraging strong, positive relationships with co-workers across the organization.
Key Duties/Responsibilities
Serves as a ClinicalResearch Manager within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring monitoring compliance with timelines and study milestones for JNJ MedTech - Electrophysiology
Provide leadership and oversight for monitoring activities of clinical trials, aligning activities with broader study objectives, and providing input on trial design to optimize monitoring efficiency and effectiveness
Experience documenting and sharing insights into trial monitoring activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality); external partners e.g. principal investigators and support staff, and internal partners e.g. study team, management and leadership staff
Contribute to the oversight of feasibility, selection, set up, conduct and closure of a clinical trial as related to monitoring activities within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures
Perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits
May be involved in the management and oversight of device ordering, tracking, and accountability of investigational products and trial materials
May be involved in the team's interface and collaboration with key opinion leaders, site investigators, IRBs/ECs, Regulatory agencies, contractors/vendors, societies, associations and company personnel
Provide input on clinical data review to prepare data for statistical analyses and publications
Lead on-site procedural protocol compliance and data collection to the clinical trial sites
Is responsible for delivery of monitoring deliverables for assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs)
May liaise with regional partners to ensure global standard processes are shared and applied across the organization
Plans, tracks and manages assigned monitoring project budgets to ensure adherence to business plans
Ensures resources assigned to designated clinical trials to provide quality deliverables while maintaining efficiency
Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
Should develop a strong understanding of the pipeline, product portfolio and business needs
Manages work independently. Independently solves problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed;
Responsible for communicating business related issues or opportunities to next management level
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures;
Performs other duties assigned as needed
Qualifications :
Required Education & Skills/Experience:
Minimum of a bachelor's degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 8 years clinicalresearch experience is required
OR
Masters degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 7 years clinicalresearch experience is required
OR
PhD in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 5 years clinicalresearch experience is required
Previous experience in managing or supervising global clinical trials
A minimum of 2 years leadership / management role within ClinicalResearch including 1-2 years of people management experience is required.
Clinical project leadership across multiple studies/ programs is required.
Experience working well with cross-functional teams is required.
Experience with budget planning, tracking and control is required.
Medical Device experience is required.
Preferred Education & Skills/Experience:
Bachelor's Degree in Life Science, Physical Science, Nursing, or Biological Science is preferred.
Relevant industry certifications are preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, …).
Clinical/medical background is a plus.
Other:
This position may require up to 25% travel depending on the phase of the program.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource.
#PULSE #EP
Required Skills:
Preferred Skills:
The anticipated base pay range for this position is :
$117,000.00 - $201,250.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - *********************************************
$117k-201.3k yearly Auto-Apply 13d ago
Manager, Clinical Research (Irvine, CA) - Johnson and Johnson MedTech, Electrophysiology
8427-Janssen Cilag Manufacturing Legal Entity
Clinical research coordinator job in Irvine, CA
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Clinical Development & Research - Non-MD
Job Category:
People Leader
All Job Posting Locations:
Irvine, California, United States of America
Job Description:
Johnson & Johnson MedTech Electrophysiology is recruiting for a ClinicalResearch, Manager, to support the Electrophysiology (EP) business unit based in Irvine, CA.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at *******************/.
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech.
Key Responsibilities:
Leads evidence generation and dissemination strategy for APAC region, including developing and implementing publication plan
Leads publication planning and oversees the development of publications (e.g. abstracts, posters, congress presentations, manuscripts) in partnership with local APAC teams
Develops positive relationship with diverse cross-functional teams including ClinicalResearch, Medical Affairs, Health Economics and Market Access, Global Strategic Marketing etc. to drive timely project's execution and success
Qualifications
A minimum of a Bachelor's or Master's Degree with a minimum of 10 years of clinical, medical affairs or related technical experience, OR PhD/MD/ PharmD with a minimum of 8 years of industry/academic research experience preferred. A Life Science, Physical Science, Nursing, or Biological Science degree.
Required:
Knowledge of Good Clinical Practices, Good Publication Practices, and ICMJE standard
Able to influence others along with strong written and oral communication skills
Strong medical writing and systematic literature review experience
Advanced project management skills with the ability to balance multiple projects
Strategic mentality and critical analysis skill
Preferred:
Successful experience in publication planning and leadership in EGS/EDS within medical device highly preferred
Proficiency/fluency in Mandarin/Chinese language preferred
Medical device experience, especially in neurovascular therapeutic experience advantageous
Pre- or Post-market study design experience
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. ·
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Employees are eligible for the following time off benefits:
Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below. *********************************************
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource.
#PULSE #EP
Required Skills:
Preferred Skills:
The anticipated base pay range for this position is :
$117,000.00 - $201,250.00
Additional Description for Pay Transparency:
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to:
*********************************************
$117k-201.3k yearly Auto-Apply 13d ago
Manager, Clinical Research (Irvine, CA) Johnson and Johnson MedTech, Electrophysiology
6010-Biosense Webster Legal Entity
Clinical research coordinator job in Irvine, CA
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Clinical Development & Research - Non-MD
Job Category:
People Leader
All Job Posting Locations:
Irvine, California, United States of America
Job Description:
Johnson & Johnson MedTech Electrophysiology is recruiting for a ClinicalResearch, Manager, to support the Electrophysiology (EP) business unit based in Irvine, CA.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at *******************/.
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech.
Key Responsibilities:
Leads evidence generation and dissemination strategy for EMEA region, including developing and implementing publication plan
Leads publication planning and oversees the development of publications (e.g. abstracts, posters, congress presentations, manuscripts) in partnership with local EMEA teams
Manages all steering committee meetings and related activities for publication plan with EMEA KOLs
Develops positive relationship with diverse cross-functional teams including ClinicalResearch, Medical Affairs, Health Economics and Market Access, Global Strategic Marketing etc. to drive timely project's execution and success
Qualifications
A minimum of a Bachelor's or Master's Degree with a minimum of 10 years of clinical, medical affairs or related technical experience, OR PhD/MD/ PharmD with a minimum of 8 years of industry/academic research experience preferred. A Life Science, Physical Science, Nursing, or Biological Science degree.
Required:
Knowledge of Good Clinical Practices, Good Publication Practices, and ICMJE standard
Able to influence others along with strong written and oral communication skills
Strong medical writing and systematic literature review experience
Advanced project management skills with the ability to balance multiple projects
Strategic mentality and critical analysis skill
Preferred:
Successful experience in publication planning and leadership in EGS/EDS within medical device highly preferred
Proficiency/fluency in Mandarin/Chinese language preferred
Medical device experience, especially in neurovascular therapeutic experience advantageous
Pre- or Post-market study design experience
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. ·
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Employees are eligible for the following time off benefits:
Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below. *********************************************
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource.
#PULSE #EP
Required Skills:
Preferred Skills:
The anticipated base pay range for this position is :
$117,000.00 - $201,250.00
Additional Description for Pay Transparency:
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
*********************************************
$117k-201.3k yearly Auto-Apply 60d+ ago
Regional Clinical Research Associate
Kelly Services 4.6
Clinical research coordinator job in Irvine, CA
Kelly Science and Clinical FSP is currently seeking a Regional ClinicalResearch Associate for a long-term engagement in the US with one of our Global Medical Device clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
- Regional travel flexing up to 75%
- Pay range will depend on location and years of experience (100k - 130+k range)
- Looking for 3+ years of medical device monitoring experience as a CRA or Sr CRA to be considered
**Job Expectations: **
+ To support 1-3 protocols in the cardiovascular/electrophysiology medical device space.
+ The ideal candidate will have **cardiovascular medical device monitoring experience- however, cardiovascular/electrophysiology pharma monitoring experience** will be considered.
+ **3+ years of monitoring experience required** .
+ Bachelor's degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
+ Candidates must have In-depth knowledge of FDA regulations and ICH/GCP guidelines.
+ Strong problem-solving skills to mitigate risks and identify issues at sites and implement effective solutions promptly.
+ Strong interpersonal skills to establish and maintain effective working relationships with site personnel, investigators, and internal teams.
+ Exceptional verbal and written communication skills, with the ability to convey complex information clearly and concisely.
+ Ability to tailor communication style to the needs and preferences of different stakeholders, fostering a collaborative environment.
+ Ability to work independently and manage multiple priorities in a dynamic environment.
+ A well-executed plan for communication with the study teams and sites.
+ Well-versed in clinical trial management. They are rigorous, detail-oriented, and precise in their reports.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (********************************************************************* for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
$55k-77k yearly est. 1d ago
Clinical Research Manager - JJMT Electrophysiology
J&J Family of Companies 4.7
Clinical research coordinator job in Irvine, CA
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
**Job Function:**
Discovery & Pre-Clinical/Clinical Development
**Job Sub** **Function:**
Clinical Development & Research - Non-MD
**Job Category:**
People Leader
**All Job Posting Locations:**
Irvine, California, United States of America
**Job Description:**
Our J&J MedTech Electrophysiology clinical team is currently recruiting for a **ClinicalResearch Manager** . The preferred location is Irvine, CA on a hybrid work schedule of 2 -3 days a week onsite. We are open to remote applicants. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at *******************/.
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech
**Summary:**
Under limited supervision, this ClinicalResearch Manager will provide leadership to a team of ClinicalResearch Leaders (CRLs) and ClinicalResearch Specialists (CRSs) and ensure the successful performance and delivery of project deliverables, on time with high quality. The ClinicalResearch Manager will be responsible for encouraging strong, positive relationships with co-workers across the organization.
**Key Duties/Responsibilities**
+ Serves as a ClinicalResearch Manager within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring monitoring compliance with timelines and study milestones for JNJ MedTech - Electrophysiology
+ Provide leadership and oversight for monitoring activities of clinical trials, aligning activities with broader study objectives, and providing input on trial design to optimize monitoring efficiency and effectiveness
+ Experience documenting and sharing insights into trial monitoring activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality); external partners e.g. principal investigators and support staff, and internal partners e.g. study team, management and leadership staff
+ Contribute to the oversight of feasibility, selection, set up, conduct and closure of a clinical trial as related to monitoring activities within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures
+ Perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits
+ May be involved in the management and oversight of device ordering, tracking, and accountability of investigational products and trial materials
+ May be involved in the team's interface and collaboration with key opinion leaders, site investigators, IRBs/ECs, Regulatory agencies, contractors/vendors, societies, associations and company personnel
+ Provide input on clinical data review to prepare data for statistical analyses and publications
+ Lead on-site procedural protocol compliance and data collection to the clinical trial sites
+ Is responsible for delivery of monitoring deliverables for assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs)
+ May liaise with regional partners to ensure global standard processes are shared and applied across the organization
+ Plans, tracks and manages assigned monitoring project budgets to ensure adherence to business plans
+ Ensures resources assigned to designated clinical trials to provide quality deliverables while maintaining efficiency
+ Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
+ Should develop a strong understanding of the pipeline, product portfolio and business needs
+ Manages work independently. Independently solves problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed;
+ Responsible for communicating business related issues or opportunities to next management level
+ Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable
+ For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
+ Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures;
+ Performs other duties assigned as needed
**Qualifications :**
**Required Education & Skills/Experience:**
+ Minimum of a bachelor's degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 8 years clinicalresearch experience is required
OR
Masters degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 7 years clinicalresearch experience is required
**OR**
PhD in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 5 years clinicalresearch experience is required
+ Previous experience in managing or supervising global clinical trials
+ A minimum of 2 years leadership / management role within ClinicalResearch including 1-2 years of people management experience is required.
+ Clinical project leadership across multiple studies/ programs is required.
+ Experience working well with cross-functional teams is required.
+ Experience with budget planning, tracking and control is required.
+ Medical Device experience is required.
**Preferred Education & Skills/Experience:**
+ Bachelor's Degree in Life Science, Physical Science, Nursing, or Biological Science is preferred.
+ Relevant industry certifications are preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, ...).
+ Clinical/medical background is a plus.
**Other:**
+ This position may require up to 25% travel depending on the phase of the program.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource.
\#PULSE #EP
**Required Skills:**
**Preferred Skills:**
**The anticipated base pay range for this position is :**
$117,000.00 - $201,250.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - *********************************************
$117k-201.3k yearly 60d+ ago
Clinical Study Coord
Aa067
Clinical research coordinator job in Irvine, CA
Clinical Study Coord - (10031602) Description Clinical Study Coordinator - ClinicalResearch (On-Site)-IrvineJoin the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses.
City of Hope's growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix.
Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today.
Orange County Medical Center seeks a full-time, on-site Clinical Study Coordinator to support oncology clinical trials.
Under the supervision of the Director, ClinicalResearch, this patient-facing role involves coordinating First in Human to Phase III and Investigator-Initiated Trials.
Responsibilities include patient recruitment, informed consent, trial coordination, data management, and regulatory compliance.
The position requires in-depth knowledge of clinical trial regulations, strong organizational skills, and the ability to collaborate with investigators and clinical staff in a fast-paced environment.
As a successful candidate, you will: Understand and apply federal regulations (FDA, OHRP, GCP/ICH, HIPAA) and institutional policies.
Follow and execute clinical trial protocols and procedures.
Coordinate participant recruitment, informed consent, and care.
Communicate with participants, investigators, and sponsors to ensure clear understanding and compliance.
Monitor and document participant eligibility, safety, and protocol adherence, and report adverse events promptly.
Pursue continuous education and training opportunities, staying updated with the latest clinicalresearch information, and maintain necessary certifications and licensure.
Qualifications - External Qualifications - External Qualifications - External Qualifications Your qualifications should include: Bachelor's degree in Science, Health or related field from an accredited university; 3 additional years of experience plus the minimum experience requirement may substitute for minimum education.
Minimum of 2 years research or relevant clinical experience ACRP or SOCRA certification within 1 year of employment International Air Transport Association (IATA) within 1 month of employment Good Clinical Practice (GCP) within 1 month of employment Human Subjects Protection (HSP) within 1 month of employment Basic Life Support (BLS) within 1 month of employment City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location.
City of Hope is an equal opportunity employer.
To learn more about our commitment to diversity, equity, and inclusion, please click here.
To learn more about our Comprehensive Benefits, please CLICK HERE.
Primary Location: United States-California-IrvineJob: ResearchCoordinationWork Force Type: OnsiteShift: DaysJob Posting: Nov 5, 2025Minimum Hourly Rate ($): 43.
176100Maximum Hourly Rate ($): 66.
922400
$78k-127k yearly est. Auto-Apply 2h ago
Senior Clinical Research Coordinator (CRC)
Smarter HR Solutions
Clinical research coordinator job in Orange, CA
***Please note: This position is onsite and not remote. Candidates must be based in the Orange, CA area, as relocation assistance is not provided. Only individuals authorized to work in the U.S. will be considered.*** Job description
Job Title: Senior ClinicalResearchCoordinator (Liver Trials)
Job Type: Full\-Time | On\-Site
Job Location: Orange, CA
Job Salary: $90,000\-$100,000 per year (based on experience)
Industry: ClinicalResearch | Hepatology | Phase I-IV Trials
About Us:
We're a fast\-paced, compliance\-driven researchclinic specializing in liver disease trials-from NASH and cirrhosis to hepatocellular carcinoma. Our team partners with leading sponsors and CROs to deliver high\-quality, audit\-ready data and compassionate patient care.
Position Overview:
This is an on\-site position in Orange, CA, and applicants must reside within a commutable distance of 50 miles or less or be able to independently relocate. THIS IS NOT A REMOTE POSITION.
We're seeking a Senior ClinicalResearchCoordinator (CRC) with hands\-on experience in liver\-focused clinical trials. You'll lead study execution, regulatory coordination, and patient engagement across multiple protocols.
MUST HAVE \- Experience in CRC in Liver\/GI\/Obesity studies
MUST HAVE \- Regulatory experience
MUST HAVE \- Fluency in Spanish
Key Responsibilities
• Coordinate Phase I-IV liver trials, including screening, enrollment, and follow\-up
• Manage regulatory submissions (IRB, CPHS), source documentation, and AE reporting
• Oversee biospecimen handling and lab coordination
• Maintain CTMS and EDC systems (REDCap, Medidata, etc.)
• Mentor junior CRCs and support cross\-functional study teams
Requirements Qualifications
• 3-5+ years of CRC experience in liver\/hepatology trials
• Strong knowledge of FDA, ICH\-GCP, and HIPAA regulations
• Proficiency in CTMS, EDC platforms, and protocol adherence
• Excellent communication and documentation skills
• Bilingual (Spanish\/English) preferred
• Familiarity with California specific regulations
Certifications
• GCP Training (Required)
• HIPAA & Human Subjects Protection (Required)
• CPHS Compliance Training (Required)
• CCRC (Certified ClinicalResearchCoordinator) (Preferred)
• CCRP (Certified ClinicalResearch Professional) (Preferred)
Benefits • Competitive salary + performance bonuses
• Health, dental, and vision coverage
• Paid training and certification support
• Career growth in a high\-impact research setting
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$90k-100k yearly 60d+ ago
Senior Clinical Research Coordinator
Headlands Research
Clinical research coordinator job in Riverside, CA
At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion.
Artemis Research is a leading principal investigator- and patient-focused clinicalresearch company dedicated to advancing medical treatments. Established in 2008 by colleagues who bring more than 50 years of combined research experience, Artemis specializes in Psychiatry/Neurology, Internal Medicine, and Women's Health studies. With multiple locations serving Southern California, including San Diego and Riverside, each Artemis site is fully equipped to conduct complex clinicalresearch trials.
Want to be a part of a growing company that's making a difference in our world? Look no further than Artemis Institute for ClinicalResearch! You'll enjoy a friendly and exciting culture with opportunities for growth and advancement. We offer the following generous benefits to our full-time employees:
A range of PPO and HMO medical plans
PPO and HMO dental plans
Vision coverage, long term disability plan, and life/AD&D coverage
401k plan
Paid holidays and paid time off
A welcoming work environment
The Role
We are seeking an experienced ClinicalResearchCoordinator/ClinicalResearchCoordinator III for our Artemis Institute of Researchclinical trial site located in Riverside, California. Under the supervision of the Site Director, the Senior ClinicalResearchCoordinator is responsible for the conduct of research protocols, such that the integrity and quality of the clinicalresearch is maintained and the research is conducted in accordance with Good Clinical Practice Guidelines. The Senior ClinicalResearchCoordinator manages study conduct from planning through study closeout.
Position Type: Full Time
Pay Range: $76,000-$90,000/yr
Location: Riverside, CA
Work Schedule: Monday through Friday, 9:30am-6:00pm
Responsibilities:
In-depth understanding of Pharmaceutical Sponsor/Industry initiated FDA studies in order to conduct the study with excellent quality
Managing all aspects of a study including participating in the informed consent process, coordinating and performing all visit study procedures per the protocol, entering data and query resolution, Investigational Product management, and managing all study related supplies and equipment, hosting monitoring visits, and attending investigator meetings
Experience managing multiple studies as the primary coordinator and someone ready to take the next step in managing people
Providing the highest level of care for study patients and delivering excellent customer service to the pharmaceutical clients
Qualifications:
Nursing license, medical assistant certificate or registration preferred
Minimum of two years of experience as a designated ClinicalResearchCoordinator on clinical trials required; sponsor-initiated and pharma clinical trials preferred
Previous clinical experience in a hands-on patient-facing role required
Commitment and ability to deliver excellent customer service
Excellent communication, punctual and responsible
Extremely well organized
Excellent verbal and written communication skills
Trustworthy, reliable; attentive to details
Mature and pleasant demeanor
Willingness to learn new tasks and grow with the company
California Pay Range$76,000-$90,000 USD
$76k-90k yearly Auto-Apply 12d ago
Clinical Research Associate - NAMSA Future Openings USA
Namsa 4.2
Clinical research coordinator job in Irvine, CA
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
Act with integrity in everything we do.
Provide best-in-class customer experiences.
Develop superior talent and deliver expertise.
Respond with agility and provide timely results.
Embrace collaboration, diverse perspectives and ideas.
Job Description:
• Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed.
• Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines.
• May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits.
• Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed.
• Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns.
• Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc.
• Performs study-related training.
• Manages the development and maintenance of study documents, processes and systems as assigned.
• Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals.
• Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance.
• Attends internal and external meetings as required.
• Provides all job-related progress reports and visit documentation as required.
• May support safety activities such as narrative writing, managing the CEC/DSMB, etc.
• OUS: Prepares and coordinates submissions to regulatory authorities.
• May perform other activities as assigned.
Qualifications & Technical Competencies:
• Fluency in English and local language, if different, required.
• Higher education degree or equivalent education, training, and experience.
• Preferred 2 years clinical trial experience.
• Preferred monitoring experience.
• Able to work independently once trained.
• Good verbal and written communication skills.
• Strong organizational skills.
• Basic computer proficiency.
• Understanding of clinicalresearch processes and regulations.
• Certifications such as Society of ClinicalResearch Associates (SoCRA) or Association of ClinicalResearch Professionals (ACRP) Certification preferred but not required
Working Conditions:
• Up to 20% travel for In-House ClinicalResearch Associates; up to 80% travel for Field ClinicalResearch Associates.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
• Extensive use of a computer keyboard.
Pay Range Minimum:
$54,400.00
Pay Range Target:
$80,100.00
Pay Frequency:
Annual
Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.
NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Fair Chance Employment Statement:
At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history.
Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position:
• May operate equipment
• Records data timely and accurately
• May analyze and interpret data
• Conducts studies on medical devices that have an impact on human life
A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.
$54.4k-80.1k yearly Auto-Apply 60d+ ago
Senior Clinical Research Coordinator
University of California System 4.6
Clinical research coordinator job in Orange, CA
Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs. It's located in one of the world's safest and most economically vibrant communities and is Orange County's second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.To learn more about UC Irvine, visit ************
The Alpha Clinic (AC) provides a centralized infrastructure from which to work with UCI faculty and staff to enhance cell and gene therapy clinical trials and activities at UCI. The UCI Alpha Clinic: • Is part of the California Institute for Regenerative Medicine (CIRM) Alpha Clinic network • Promotes and facilitates scientific collaborations and interactions • Provides centralized clinicalresearch infrastructure support for cell and gene therapy clinical trials • Accelerates the implementation of cell and gene therapy clinical trials at UCI
Responsibilities
Under the direction of the Assistant Director of ClinicalResearch Operations, the Senior ClinicalResearchCoordinator will be responsible for supporting clinicalresearch efforts of the UCI Alpha Clinic (AC) by providing comprehensive coordination and data management of sponsored clinical trials according to Good Clinical Practices (GCP), internal standard operating procedure (SOPs), and University policies and procedures. The incumbent is responsible for supporting and coordinating all aspects of UCI AC trials and studies for protocol specific requirements, research procedures, research chart preparation, data collection, subject study management and record keeping. Attends clinic to assist the Principal Investigator (PI) with recruitment, screening, consenting, administering questionnaires, etc. Incumbent will ensure study protocols are followed, appropriate documentation is kept, and accurate data is collected. Incumbent will be responsible for the preparation and submission of study documents to the Institutional Review Board (IRB), Sponsored Projects Administration (SPA) and other regulatory committees.
Qualifications
Required:
* Demonstrated high-level communication skills to convey information in a clear and concise way,synthesizing information and presenting it to others.
* Demonstrated problem solving capabilities to resolve concerns that arise unexpectedly.
* Demonstrated ability to research, properly evaluate information, and prepare concise, well organized reports, summaries, and correspondence.
* Demonstrated ability to organize and prioritize a complex and dynamic workload.
* Ability to multitask and meet deadlines, despite interruptions.
* Ability to independently exercise discretion and sound judgment.
* Ability to work collegially and cooperatively in a small office and to establish and maintain cooperative working relationships.
* Demonstrated skill in interacting with persons of various social, cultural, economic and educational backgrounds.
* Ability to prioritize assignments and achieve high productivity/quality with short time frames, under rigid deadlines, and /or in environments with frequent workload changes and competing demands.
* Skill in working independently, taking initiative and following through on assignments.
* Ability to think critically, compile data from various sources, analyze data, and prepare reports.
* High level of integrity and honesty in maintaining confidentiality.
* Foster and promote a positive attitude and professional appearance.
* Strong attention to detail.
* Working knowledge of computer software including Microsoft Office (Outlook, Word, Excel, and PowerPoint).
* Experience with a nationally-recognized clinicalresearchcoordinator certification
* Bachelor's degree in related area and / or equivalent experience / training.
* 3-5 years
Preferred:
* Advanced degree (MA, MS, or MPH) preferred
* Certification by the Society of ClinicalResearch Associates or the Association of ClinicalResearch Professionals.
Special Conditions:
* Flexible working hours required, may need to extend work hours into evenings and weekends on occasion
Total Compensation
In addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding. These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks. Please utilize the links listed here to learn more about our compensation practices and benefits.
Expected salary range: $87,837.15- $93,457.99
Conditions of Employment:
The University of California, Irvine (UCI) seeks to provide a safe and healthy environment for the entire UCI community. As part of this commitment, all applicants who accept an offer of employment must comply with the following conditions of employment:
* Background Check and Live Scan
* Employment Misconduct*
* Legal Right to work in the United States
* Vaccination Policies
* Smoking and Tobacco Policy
* Drug Free Environment
* Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.
The following additional conditions may apply, some of which are dependent upon business unit or job specific requirements.
* California Child Abuse and Neglect Reporting Act
* E-Verify
* Pre-Placement Health Evaluation
Details of each policy may be reviewed by visiting the following page - ********************************************************
Closing Statement:
The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status. For the University of California's Affirmative Action Policy please visit: ******************************************** For the University of California's Anti-Discrimination Policy, please visit: ******************************************************** We are committed to attracting and retaining a diverse workforce along with honoring unique experiences, perspectives, and identities. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming. UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at ************** or ***********.
$87.8k-93.5k yearly 25d ago
Senior Associate, Clinical Research
Jenavalve Technology
Clinical research coordinator job in Irvine, CA
Job Title: Senior Associate, ClinicalResearch
Supervisor/Manager Title: Director, Clinical Affairs
Job Description Summary: The Senior ClinicalResearch Associate will report to the Associate Director, Clinical Programs, and will play a key role in proactively supporting the conduct of pre-market clinical studies and ensure compliance with all regulatory requirements. The ideal candidate will have a thorough knowledge of Good Clinical Practices (GCP) and applicable regulations.
Job Responsibilities:
Support site management and interact with site coordinators, investigators, and field monitors in collecting data and resolving queries to meet the protocol requirements in a timely manner.
Ensure quality data management activities - i.e., data review, query generation and resolution. Generate status reports to clinical staff and management.
Generate queries to resolve data issues and apply corrections to database.
Act as a point person for all data related to clinical group, and to provide data to cross-functional departments.
Conduct EDC training to external teams and sites.
Maintain Trial Master Files and trackers for clinical trials.
Manage trial-related regulatory documents and provide follow-up action listings to ensure that all clinical documentation required by regulations and JenaValve procedures is current.
Conduct periodic audits of internal files to ensure compliance per site Institutional Review Board (IRB) and/or Ethics Committee (EC) policy (i.e. IRB continuing review approval period and expiration dates).
Provide clinical operational support during preparation for and conduct of all clinical audits and inspections.
Contribute to the development and implementation of departmental policies, standards, and process improvement initiatives.
Partner with management to manage external vendors, including ongoing supplier qualification.
Assist field clinical monitors in preparation for site training and monitoring visits
Support co-monitoring of local sites on an as-needed basis.
Qualifications
Required Education and Experience:
2+ year of experience in clinical trial research is required (preferred in medical devices).
Advanced degree in a biological science / pharmacy/ nursing desired.
Skills and Abilities Required for This Job:
Proficient in clinical trial management and electronic data capture systems to document and record information.
Excellent communication skills (written and verbal English) so as to be able to build effective relationships with trial center staff and colleagues.
Deep knowledge of GCPs governing the conduct of clinical trials; working knowledge of Medical Device Directive 93/42/EEC, ISO14155 and ICH guidelines.
Very organized and able to pay close attention to detail.
Team player with a willingness to help where needed and work with diverse people.
Ability to travel up to 20% time.
$81k-129k yearly est. 17d ago
Manager Clinical Research
Providence Health & Services 4.2
Clinical research coordinator job in Orange, CA
Under the supervision of the Director, the Manager of ClinicalResearch is responsible for assuring the strategic vision, directions and operations of the clinicalresearch department are implemented and adhered to by all local network site staff and disease oriented teams. Responsible for oversight of the day to day operations of all local network site staff and disease oriented teams, as well as leading the program in relationship with Local and Health System initiatives. Responsibilities include assessing protocol participation by /participating practices, compliance with regulations and assure good communication between the various ministries, stakeholders and leadership. Assists in developing, implementing and maintaining policies and procedures.
Providence caregivers are not simply valued - they're invaluable. Join our team at Providence Medical Foundation and thrive in our culture of patient-focused, whole-person care built on understanding, commitment, and mutual respect. Your voice matters here, because we know that to inspire and retain the best people, we must empower them.
Required Qualifications:
+ Bachelor's Degree in Nursing or health related field preferred.
+ ACRP or SOCRA certification, or other ClinicalResearch Certification upon hire.
+ 7 years of Clinicalresearch experience.
+ 5 years in management or supervision of clinical trials.
+ Experience in managing data collection, reporting, outcomes, quality improvement, standards/pathways.
+ Experience in meeting FDA (GCP, ICH guidelines), as well as other Federal, State and Local regulations surrounding human research and gene therapy practices.
+ Experience with working with Pharmaceutical and FDA agency representatives.
Preferred Qualifications:
+ Master's Degree
Why Join Providence?
Our best-in-class benefits are uniquely designed to support you and your family in staying well, growing professionally, and achieving financial security. We take care of you, so you can focus on delivering our Mission of caring for everyone, especially the most vulnerable in our communities.
About Providence
At Providence, our strength lies in Our Promise of "Know me, care for me, ease my way." Working at our family of organizations means that regardless of your role, we'll walk alongside you in your career, supporting you so you can support others. We provide best-in-class benefits and we foster an inclusive workplace where diversity is valued, and everyone is essential, heard and respected. Together, our 120,000 caregivers (all employees) serve in over 50 hospitals, over 1,000 clinics and a full range of health and social services across Alaska, California, Montana, New Mexico, Oregon, Texas and Washington. As a comprehensive health care organization, we are serving more people, advancing best practices and continuing our more than 100-year tradition of serving the poor and vulnerable.
Posted are the minimum and the maximum wage rates on the wage range for this position. The successful candidate's placement on the wage range for this position will be determined based upon relevant job experience and other applicable factors. These amounts are the base pay range; additional compensation may be available for this role, such as shift differentials, standby/on-call, overtime, premiums, extra shift incentives, or bonus opportunities.
Providence offers a comprehensive benefits package including a retirement 401(k) Savings Plan with employer matching, health care benefits (medical, dental, vision), life insurance, disability insurance, time off benefits (paid parental leave, vacations, holidays, health issues), voluntary benefits, well-being resources and much more. Learn more at providence.jobs/benefits.
Applicants in the Unincorporated County of Los Angeles: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Unincorporated Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
About the Team
Providence Clinical Network (PCN) is a service line within Providence serving patients across seven states with quality, compassionate, coordinated care. Collectively, our medical groups and affiliate practices are the third largest group in the country with over 11,000 providers, 900 clinics and 30,000 caregivers.
PCN is comprised of Providence Medical Group in Alaska, Washington, Montana and Oregon; Swedish Medical Group in Washington's greater Puget Sound area, Pacific Medical Centers in western Washington; Kadlec in southeast Washington; Providence's St. John's Medical Foundation in Southern California; Providence Medical Institute in Southern California; Providence Facey Medical Foundation in Southern California; Providence Medical Foundation in Northern and Southern California; and Covenant Medical Group and Covenant Health Partners in west Texas and eastern New Mexico.
Providence is proud to be an Equal Opportunity Employer. We are committed to the principle that every workforce member has the right to work in surroundings that are free from all forms of unlawful discrimination and harassment on the basis of race, color, gender, disability, veteran, military status, religion, age, creed, national origin, sexual identity or expression, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law. We believe diversity makes us stronger, so we are dedicated to shaping an inclusive workforce, learning from each other, and creating equal opportunities for advancement.
Requsition ID: 403193
Company: Providence Jobs
Job Category: Research
Job Function: Clinical Support
Job Schedule: Full time
Job Shift: Day
Career Track: Leadership
Department: 7520 RESEARCH PROJECTS CA HERITAGE SERVICES
Address: CA Orange 1100 W Stewart Dr
Work Location: St Joseph Hospital-Orange
Workplace Type: On-site
Pay Range: $58.79 - $92.82
The amounts listed are the base pay range; additional compensation may be available for this role, such as shift differentials, standby/on-call, overtime, premiums, extra shift incentives, or bonus opportunities.
$58.8-92.8 hourly Auto-Apply 43d ago
Clinical Research Coordinator - Loma Linda, CA
Iqvia 4.7
Clinical research coordinator job in Loma Linda, CA
**Work Set-Up:** On-site **Schedule:** Full-time, 40 hours per week **About the Role** We are seeking a **ClinicalResearchCoordinator (CRC)** to join our team and support clinicalresearch studies under the supervision of a principal investigator. This role involves hands-on clinical procedures, community outreach, and ensuring the highest standards of care and compliance.
**About IQVIA**
IQVIA is a global leader in advanced analytics, technology solutions, and clinicalresearch services, dedicated to driving healthcare forward. We partner with the world's leading pharmaceutical, biotechnology, and medical device companies to improve patient outcomes and accelerate innovation. Our team combines deep scientific expertise with cutting-edge technology to deliver high-quality data and insights that shape the future of clinical trials.
**Key Responsibilities**
+ Perform a variety of complex clinical procedures, including ECG, spirometry, sample collection, and vital signs.
+ Phlebotomy is required; pediatric experience is highly preferred.
+ Coordinateclinicalresearch studies and maintain compliance with protocols and Good Clinical Practice (GCP) guidelines.
+ Support study conduct by preparing study materials, setting up equipment, and planning logistical activities.
+ Recruit, screen, and orient volunteers, ensuring their safety and well-being throughout the study.
+ Collect and accurately record clinical data in case report forms (CRFs).
+ Collaborate with investigators and monitors, addressing queries and ensuring data quality.
+ Act as a volunteer advocate and maintain a safe environment in accordance with Health and Safety policies.
**Qualifications**
+ High School Diploma or equivalent education and experience.
+ Minimum 1 year of relevant work experience in clinicalresearch (preferred).
+ Working knowledge of clinical trials, GCP principles, and medical terminology.
+ Strong attention to detail and ability to establish effective working relationships.
**Please note:** This position is **not eligible for sponsorship** .
\#LI-CES #LI-DNP #LI-HCP #ONSITE
IQVIA is a leading global provider of clinicalresearch services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at **********************
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe
The potential base pay range for this role is $35.00-$42.00 per hour. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinicalresearch services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
$35-42 hourly 53d ago
Clinical Study Coord
City of Hope 3.9
Clinical research coordinator job in Irvine, CA
Clinical Study Coordinator - ClinicalResearch (On-Site)-Irvine Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope's growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today.
Orange County Medical Center seeks a full-time, on-site Clinical Study Coordinator to support oncology clinical trials. Under the supervision of the Director, ClinicalResearch, this patient-facing role involves coordinating First in Human to Phase III and Investigator-Initiated Trials. Responsibilities include patient recruitment, informed consent, trial coordination, data management, and regulatory compliance. The position requires in-depth knowledge of clinical trial regulations, strong organizational skills, and the ability to collaborate with investigators and clinical staff in a fast-paced environment.
As a successful candidate, you will:
* Understand and apply federal regulations (FDA, OHRP, GCP/ICH, HIPAA) and institutional policies.
* Follow and execute clinical trial protocols and procedures.
* Coordinate participant recruitment, informed consent, and care.
* Communicate with participants, investigators, and sponsors to ensure clear understanding and compliance.
* Monitor and document participant eligibility, safety, and protocol adherence, and report adverse events promptly.
* Pursue continuous education and training opportunities, staying updated with the latest clinicalresearch information, and maintain necessary certifications and licensure.
Qualifications - External
Qualifications - External
Qualifications - External
Your qualifications should include:
* Bachelor's degree in Science, Health or related field from an accredited university; 3 additional years of experience plus the minimum experience requirement may substitute for minimum education.
* Minimum of 2 years research or relevant clinical experience
* ACRP or SOCRA certification within 1 year of employment
* International Air Transport Association (IATA) within 1 month of employment
* Good Clinical Practice (GCP) within 1 month of employment
* Human Subjects Protection (HSP) within 1 month of employment
* Basic Life Support (BLS) within 1 month of employment
City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location.
City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please click here.
To learn more about our Comprehensive Benefits, please CLICK HERE.
$65k-93k yearly est. 25d ago
Clinical Research Coordinator
Providence 3.6
Clinical research coordinator job in Orange, CA
Under the supervision of the Medical Office Administrator, the ClinicalResearchCoordinator oversees the day to day functions of multiple clinicalresearch studies. This role is responsible for interfacing with the Principal Investigator, Patient, Sponsor, and the IRB. This position is directly responsible to ensure that all documentation is timely and accurate and works closely with the PI to ensure strict compliance to study protocols (GCP/ICH).
Providence caregivers are not simply valued - they're invaluable. Join our team at Providence Medical Foundation and thrive in our culture of patient-focused, whole-person care built on understanding, commitment, and mutual respect. Your voice matters here, because we know that to inspire and retain the best people, we must empower them.
Required Qualifications:
Coursework/Training - Completion of an accredited Medical or Phlebotomy training program or equivalent educ/experience.
Preferred Qualifications:
Graduate of a Vocational School or college.
Coursework/Training - Biohazardous Material packaging training.
F02 AMG Clinical Trials: Required to have College Degree.
Phlebotomy Certificate (for department SJuHMG Clinical Trials) upon hire.
2 years - Experience in a ClinicalResearch setting. 3 years preferred.
Why Join Providence?
Our best-in-class benefits are uniquely designed to support you and your family in staying well, growing professionally, and achieving financial security. We take care of you, so you can focus on delivering our Mission of caring for everyone, especially the most vulnerable in our communities.
$49k-72k yearly est. Auto-Apply 56d ago
Clinical Research Operations Specialist -Temporary
City of Loma Linda 3.7
Clinical research coordinator job in Loma Linda, CA
MC: Cancer Institute Core- Temporary- Full-Time, Day Shift
Job Summary: The ClinicalResearch Operations Specialist for the Cancer Center Clinical Trials Unit (CCCTU) plays a critical role in the financial management of clinicalresearch trials from study startup to study closure. The ClinicalResearch Operations Specialist participates in the start-up activities related to opening new trials, including performing financial feasibility assessments, and will work closely with the Principal Investigator, study start-up team and Research Affairs Financial Management to ensure accurate and compliant budget development and negotiation. Develops the Medicare Coverage Analysis to begin budget development. Creates new studies in the OnCore Clinical Trial Management System and tract contract milestones and EPIC to support charge review and research billing compliance. The ClinicalResearch Operations Specialist develops and negotiates budgets for clinical trials working with sponsors, ancillary departments, and billing offices. This position requires the ability to interpret study protocols, identify billable vs research-only procedures and ensure alignment between clinical activities and financial workflows. Facilitates and processes financial transactions for clinical trial accounts. Performs other duties as needed.
Education and Experience: Bachelor's Degree in Healthcare Administration, Finance, or account required. Minimum two years experience in clinicalresearch finance, budget development or contract negotiation required. Experience with oncology clinical trials at an academic medical center or cancer research institution preferred.
Knowledge and Skills: Knowledge of clinical trial practices, billing compliance regulation, Medical coverage analysis, and medical terminology. Familiarity with budgeting for cell therapy studies. Experience with early phase or complex trial designs. Knowledge of fair market value standards and budgeting practices for high-cost research procedures. Working knowledge of CPT codes, RVUs, and Medicare billing practices in clinicalresearch. Read, write legibly, and speak in English with professional quality; use computer, printer, and software programs necessary to the position (e.g., Word, Excel, Outlook, PowerPoint). Operate/troubleshoot basic office equipment required for the position. Relate and communicate positively, effectively, and professionally with others; work calmly and respond courteously when under pressure; collaborate and accept direction. Think critically; manage multiple assignments effectively; organize and prioritize workload; work well under pressure; problem solve; recall information with accuracy; pay close attention to detail; work independently with minimal supervision. Distinguish colors as necessary; hear sufficiently for general conversation in person and on the telephone, and identify and distinguish various sounds associated with the workplace; see adequately to read computer screens, and written documents necessary to the position.
Licensures and Certifications: None.
$48k-68k yearly est. Auto-Apply 12d ago
Clinical Research Coordinator
Flourish Research
Clinical research coordinator job in Covina, CA
Job Description
Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities.
We are actively hiring ClinicalResearchCoordinators at our Covina site location. This location has been serving the Greater LA community since 2010 and specializes in Cardiovascular and Metabolic clinical trials.
The ClinicalResearchCoordinator assists the Investigators in executing Phase I, II, III, and IV clinicalresearch trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction.
Shift: Monday-Friday, 8:30 AM - 5 PM (occasional weekends)
Location: 315 N 3rd Ave #103, Covina, CA 91723
Compensation: $33-$38/hr (depending on experience)
Benefits: Health, dental, and vision insurance plans, 401(k) with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays.
RESPONSIBILITIES
Execute protocol-specified patient visits and procedures, which may include, but not limited to, phlebotomy, IVs, injections, vital signs, ECG/EKG, etc.
Document assessments and study data per regs/GCP; maintain complete source; accurately complete CRFs/eCRFs.
Obtain informed consent per federal regs, GCP, and IRB requirements.
Ethically recruit qualified subjects to meet enrollment timelines.
Complete required/ongoing training; attend investigator meetings/courses; stay current with changing regulations and Flourish policies.
Schedule and conduct visits per protocol timelines.
Protect confidentiality per HIPAA and all confidentiality agreements.
Report AEs promptly; report SAEs to sponsor within 24 hours and notify PI/Sub-I/supervisor.
Account for and ensure availability of trial materials (study drug, labs, CRFs, supplies).
Maintain and document communication with Leads, Managers, PIs/Sub-Is, and study team per protocol and policy.
Perform duties safely, and in a time-/cost-effective manner compliant with Flourish policies.
Represent Flourish professionally in all interactions.
Additional duties as assigned by management.
QUALIFICATIONS
Bachelor's degree preferred, but not required
Minimum of two years of sponsor-backed clinicalresearch experience
Clinical skills highly preferred: vital signs, EKG/ECG, phlebotomy, and injections
Familiar with e-source reporting via an electronic platform
A clear understanding of ICH, FDA, and GCP regulations
Impeccable organizational skills and attention to detail
Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources
An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven
High-level critical thinking skills
Working knowledge of medical terminology and lab collection/processing/storage procedures
Proficiency with computers and Microsoft Office Suite
Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others!
Flourish Research is where clinical trials thrive.
Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines.
At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality.
Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect.
Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!
It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.
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$33-38 hourly 5d ago
Clinical Research Coordinator II (Huntington Beach, CA)
Care Access 4.3
Clinical research coordinator job in Irvine, CA
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like
Future of Medicine
, which makes advanced health screenings and research opportunities accessible to communities worldwide, and
Difference Makers
, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinicalresearch and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit *******************
How This Role Makes a Difference
The ClinicalResearchCoordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinicalresearch study subjects while ensuring protocol and regulatory compliance.
How You'll Make An Impact
Duties include but not limited to:
Ability to understand and follow institutional SOPs.
Review and assess protocol (including amendments) for clarity, logistical feasibility
Ensure that all training and study requirements are met prior to trial conduct.
Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.
Assist with planning and creation of appropriate recruitment materials
Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.
Actively work with recruitment team in calling and recruiting subjects
Attend Investigator meetings as required.
Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
Assist in the creation and review of source documents.
Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
Study Management
Prioritize activities with specific regard to protocol timelines
Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
Maintain effective relationships with study participants and other care Access Research personnel.
Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.
Communicate clearly verbally and in writing.
Patient Coordination
Prescreen study candidates
Obtain informed consent per Care Access Research SOP
Complete visit procedures in accordance with protocol.
Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.
Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
Documentation
Record data legibly and enter in real time on paper or e-source documents
Accurately record study medication inventory, medication dispensation, and patient compliance.
Resolve data management queries and correct source data within sponsor provided timelines
Assist regulatory personnel with completion and filing of regulatory documents.
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
The Expertise Required
Excellent working knowledge of medical and research terminology
Excellent working knowledge of federal regulations, good clinical practices (GCP)
Ability to communicate and work effectively with a diverse team of professionals.
Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail
Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.
Critical thinker and problem solver
Friendly, outgoing personality; maintain a positive attitude under pressure.
High level of self-motivation and energy
Excellent professional writing and communication skills
Ability to work independently in a fast-paced environment with minimal supervision.
Certifications/Licenses, Education, and Experience:
Bachelor's Degree preferred, or equivalent combination of education, training and experience.
A minimum of 3 years prior ClinicalResearchCoordinator experience required
Prefer 1 year of experience as a Care Access ResearchClinicalResearchCoordinator
Recent phlebotomy experience required
Bilingual in Spanish-preferred
How We Work Together
Location: This is an on-site position with regional commute requirements. Position requires onsite work 5 days per week at the Huntington Beach, CAclinic.
Travel: Regularly planned travel within the region will be required as part of the role.
Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members.
Benefits & Perks (US Full Time Employees)
Paid Time Off (PTO) and Company Paid Holidays
100% Employer paid medical, dental, and vision insurance plan options
Health Savings Account and Flexible Spending Accounts
Bi-weekly HSA employer contribution
Company paid Short-Term Disability and Long-Term Disability
401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
$60k-90k yearly Auto-Apply 5d ago
Clinical Research Coordinator
Pacific Neuropsychiatric Specialists
Clinical research coordinator job in Orange, CA
Benefits:
401(k) matching
Dental insurance
Health insurance
Paid time off
Training & development
Vision insurance
PNS ClinicalResearch (PNSCR) is the research division of Pacific Neuropsychiatric Specialists, a private practice spanning 6 locations and 40+ providers. PNSCR conducts phase II-IV psychiatry trials for indications including MDD, Schizophrenia, Alzheimer's Disease, and bipolar disorder.
Job Summary: Under policy direction from the ClinicalResearch Director, the ClinicalResearchCoordinator will play a crucial role in supporting clinicalresearch activities, ensuring adherence to protocols, and contributing to the advancement of medical knowledge. The ClinicalResearchCoordinator is responsible for assisting in patient identification, recruitment, and enrollment strategies and performing other clinicalresearch duties for the office. The ClinicalResearchCoordinator is responsible for assisting with coordinatingclinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.
Key Responsibilities:
Assist PI, physicians, and clinical staff in patient identification, recruitment, and enrollment strategies.
Ensure patient enrollment and research activities comply with established protocols, regulatory and monitoring agency standards, and sponsor guidelines.
Screen potential patients for protocol eligibility.
Present trial concepts and details to patients, take part in the informed consent process, and enroll/randomize patients into the study.
Conduct clinical trial visits, including screening and follow-up, and track participant data per protocol requirements.
Complete accurate and concise documentation of all participant records and other source documentation and forms per protocol.
Accurately document study data in Case Report Forms (CRFs) and electronic databases, resolving any data queries from sponsors in a timely manner.
Review patient charts for changes in condition, adverse events, concomitant medication use, protocol compliance, and response to study drug, and thoroughly document all findings.
Manages the storage, dispensation, and tracking of investigational products as per protocol.
Attend Site Initiation Visits, facilitate routine monitoring visits, conduct Close Out Visits, and proactively work to resolve site action items in collaboration with trial monitors. Perform basic lab duties including processing of samples, centrifuging, storing, and shipping of study specimens.
Schedule patient screening appointments, treatments, and laboratory assessments required by the protocol.
Prepare study data for progress reports, analysis, and meeting presentations.
Participate in required clinicalresearch education and training programs.
Attend and represent the site at study-related investigator conferences
Effectively communicate and collaborate with w/ study team, including internal and external parties, sponsors, PI, and study participants.
Show initiative to identify and implement ways to improve job workflow and surroundings.
Plan work in a manner that allows timely completion of all assignments and tasks.
Required Qualifications:
Bachelor's Degree in a health-related discipline (i.e. pharmacology, nursing, biology, etc.), or equivalent experience.
1-3 years of clinicalresearch experience.
Current CPR/Basic Life Support (BLS) certification (upon hire)
Current Good Clinical Practice (GCP) Certification (upon hire)
Detail-oriented and meticulous in all aspects of work.
Ability to prioritize tasks, effectively manage time, and allocate resources efficiently to meet tight study deadlines.
Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
Preferred Qualifications:
Prior clinicalresearch experience with neurological indications such as Alzheimer's and Tardive Dyskinesia
Prior clinicalresearch experience with psychological indications such as Major Depressive Disorder, Bipolar Disorder, Schizophrenia, and PTSD
Compensation & Benefits:
PNS offers a competitive compensation package including; medical, dental, vision, and paid time off for full-time employees.
Hourly rate is based on skill, experience, and tenure of profession.
This job description is intended to outline the general responsibilities and qualifications for the ClinicalResearchCoordinator role. Duties and responsibilities may evolve, and the ClinicalResearchCoordinator may be required to perform other tasks as assigned. Compensation: $25.00 - $35.00 per hour
We are Pacific Neuropsychiatric Specialists (PNS) and our experience enables us to offer effective outpatient, individualized, psychiatry care. Our psychiatry team provides psychiatric treatments for children, adolescents, adults, and seniors, from multiple offices located throughout Orange County, we do accept patients from the entire United States as well. Our psychiatrists treat a number of mental health disorders, including anxiety, stress, PTSD, bipolar, schizophrenia, dementia, depression, ADD ADHD, alcohol and chemical dependency, and more. Our Psychiatry practice was founded on the principles of treating patients with care, compassion, and understanding.
$25-35 hourly Auto-Apply 28d ago
Learn more about clinical research coordinator jobs
How much does a clinical research coordinator earn in Yucaipa, CA?
The average clinical research coordinator in Yucaipa, CA earns between $41,000 and $87,000 annually. This compares to the national average clinical research coordinator range of $37,000 to $72,000.
Average clinical research coordinator salary in Yucaipa, CA