Clinical Research Associate I - Heart Institute
Clinical research coordinator job in Los Angeles, CA
The Smidt Heart Institute reflects Cedars-Sinai's steadfast dedication to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and niche care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes.
Are you ready to be a part of breakthrough research?
The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Duties & Responsibilities:
Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
Evaluates and abstracts clinical research data from source documents.
Ensures compliance with protocol and overall clinical research objectives.
Completes Case Report Forms (CRFs).
Enters clinical research data into Electronic Data Systems (EDCs) that the sponsors provide.
Provides supervised patient contact or patient contact for long term follow-up patients only.
Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Assists with clinical trial budgets.
Assists with patient research billing.
Schedules patients for research visits and research procedures.
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Qualifications
Education:
High School Diploma is required. Bachelor's degree preferred in Science, Sociology, or a related field.
Experience and Skills:
One (1) year of clinical research related experience is preferred.
Ability to interpret and apply knowledge of State, Federal, and Agency standards to comply with regulations.
Ability to convey and/or receive written/verbal information to/from various audiences in different formats.
About UsCedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.
About the TeamCedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.
Req ID : 9188
Working Title : Clinical Research Associate I - Heart Institute
Department : Heart Institute
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $24 - $32.86
Clinical Research Associate
Clinical research coordinator job in Los Angeles, CA
IDR is seeking a Clinical Research Associate to join one of our top clients in Los Angeles, CA. This role offers a unique opportunity to work onsite, fostering close collaboration with our client's team and immersing yourself in a dynamic work environment. If you are eager to be part of a growing organization with a team-oriented culture, please apply today!
Position Overview/Responsibilities for the Clinical Research Associate:
• Collaborate with the team to submit research projects for human subjects approval, including protocols, consent forms, and IRB applications.
• Manage internal documentation for contract execution and maintain communication with contracting officers and sponsors during budgeting and negotiations.
• Develop and monitor research project budgets, ensuring alignment with protocol requirements and institutional costs.
• Ensure compliance with IRB, FDA, OHRP, HIPAA, and other guidelines by maintaining high-quality regulatory files and submitting necessary paperwork.
• Coordinate site feasibility and initiation visits, and provide facility tours for research sponsors and other personnel.
Required Skills for Clinical Research Associate:
• High School Diploma or GED is required; a Bachelor's degree is preferred.
• At least one year of experience in clinical research, with a preference for experience in chemo, oncology, or pharmaceutical research.
• Strong organizational skills and attention to detail in managing research documentation and regulatory compliance.
• Ability to collaborate effectively with internal and external investigators and participating centers.
What's in it for you?
Competitive compensation package
Full Benefits; Medical, Vision, Dental, and more!
Opportunity to get in with an industry-leading organization
Close-knit and team-oriented culture
Why IDR?
25+ Years of Proven Industry Experience in 4 major markets
Employee Stock Ownership Program
Medical, Dental, Vision, and Life Insurance
ClearlyRated's Best of Staffing Client and Talent Award winner 12 years in a row
Clinical Research Coordinator 248786
Clinical research coordinator job in Beverly Hills, CA
Patient Care & Recruitment:
Screen, enroll, and educate patients about trial protocols, manage appointments, and collect follow-up data.
Protocol Adherence:
Ensure all study activities (drug administration, data collection) strictly follow the study protocol and Good Clinical Practice (GCP).
Data Management:
Collect, enter, and manage accurate study data; communicate with labs about results.
Regulatory Compliance:
Work with Institutional Review Boards (IRBs) and sponsors to maintain compliance with laws and regulations.
Team Collaboration:
Work with doctors, nurses, and other staff; train new personnel; and communicate with sponsors and regulatory bodies.
Administrative Tasks:
Manage study budgets, supplies, and development of recruitment materials.
Clinical Research Manager
Clinical research coordinator job in Anaheim, CA
Required upon hire: ACRP or SOCRA certification, or other Clinical Research Certification
Education:
Bachelor's Degree Required
Master's Degree Preferred
Experience:
- 7 years of Clinical research experience REQUIRED
- 5 years in management or supervision of clinical trials REQUIRED.
- 5 years Experience in clinical research finance REQUIRED
- Experience in managing data collection, reporting, outcomes, quality improvement, standards/pathways REQUIRED
- Experience in meeting FDA (GCP, ICH guidelines), as well as other Federal, State and Local regulations surrounding human research REQUIRED.
- Experience with working with Pharmaceutical and FDA agency representatives REQUIRED.
Summary
Under the supervision of the Director, the Manager of Clinical Research is responsible for assuring the strategic vision, directions and operations of the clinical research finance department are implemented and adhered to by all staff. Responsible for oversight of the day to day operations of the clinical research finance team. Responsibilities include compliance with regulations and assure good communication between the various ministries, stakeholders and leadership. Assists in developing, implementing and maintaining policies and procedures. Assists in providing on-going formal and informal training for research staff.
Responsible for overseeing the development of research contracting and budgeting standards. Directs the negotiation of contracts for clinical trials and determination of internal costs and development of internal budget for negotiations of sponsored and investigator initiated clinical trials in compliance with applicable state and federal laws and regulations, especially Medicare and Stark Law. Lead the development and implementation of study builds in the clinical trial management system (CTMS).
Skills Needed:
• Computer literate to include advanced level proficiency in Microsoft Office Programs (Word, Excel, Access and PowerPoint), E-mail and Internet.
• Thorough knowledge and understanding of HIPPA, GCP and ICH regulations, clinical trial monitoring, and regulatory compliance.
• Extensive Knowledge of DHHS, FDA, NCI, NIH, OHRP and other relevant regulations concerning research and compliance.
• Knowledgeable of principles of accounting and contract law affecting clinical trials.
• Ability to successfully budget and negotiate industry contracts for sponsored clinical trials.
• Highly organized and attentive to details, problem solving abilities and ability to work with minimal supervision.
• Highly motivated and able to take initiative.
• Ability to prioritize, organize, plan, and implement as well as handle multiple projects/problems simultaneously within a fast paced environment; able to collect and manage large amount of data and maintain databases; communicates progress, challenges and results effectively.
• Knowledge of operations, including human resource, budget management and work flow planning.
• Ability to plan, chair, document and follow-up on administrative and related meetings.
• Ability to work independently and with minimal supervision.
• Ability to be flexible, multi task and switch priorities as well as work comfortably in a deadline driven environment.
• Communicates well with physicians, patients, sponsors and staff on interpersonal and technical levels, both verbally and in writing; demonstrates high integrity and maintains confidentiality of all information.
• Interacts favorably with people by phone and in person, and work effectively as part of a team.
• Demonstrate communication, leadership, and team building skills; evidence of this should includes dealing well with people, effective problem solving, appropriately confronting issues, motivating others as individuals and as groups, planning, organizing and directing the activities of others.
• Excellent written/verbal communication skills to effectively interact with all levels of management, departments, and users.
Clinical Research Coordinator
Clinical research coordinator job in Los Angeles, 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 oncology research trials
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
Focus on oncology based research studies
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)
Experience working with Oncology clinical trials
R&D & Sales Project Coordinator
Clinical research coordinator job in Inglewood, CA
Don Lee Farms creates premium burgers, bowls, and tacos for America's top markets. As a multigenerational family-run company, we specialize in delivering delicious and convenient food options. Our products can be found at leading retailers like Trader Joe's, Costco, Walmart, and Sam's Club. Whether under the Don Lee Farms brand or other store labels, we make mealtimes hassle-free with our quality foods.
About the Role
We are seeking a R&D & Sales Project Coordinator to support our Sales and R&D teams in moving projects forward, preparing for customer meetings, and ensuring smooth execution of product launches. This role is ideal for someone early in their career who thrives in a fast-paced environment, enjoys problem-solving, and wants a clear path to grow into sales or account management at Don Lee Farms. This is an in-person role.
Key Responsibilities
Work closely with the Sales and R&D teams to advance up to 100 projects at a time from concept to launch.
Enter and maintain accurate product and project data in customer portals.
Coordinate across departments (R&D, operations, quality) to ensure deadlines and deliverables are met.
Join customer meetings and presentations, presenting product in support of the sales team, capturing action items, and ensuring timely follow-through (travel required).
Support the sales team with materials, presentations, and follow-up for key customer meetings.
Assist with order tracking, reporting, and general sales support as needed.
Skills & Abilities
Strong organizational skills and attention to detail.
Excellent communication and interpersonal skills; comfortable engaging with customers and internal teams.
Ability to manage multiple priorities with a proactive, solution-oriented mindset.
Proficiency in Microsoft Office (Excel, PowerPoint, Outlook) and ability to learn new systems quickly.
Commitment to developing a long-term career with Don Lee Farms in sales and commercialization.
Qualifications
Bachelor's degree preferred, or equivalent experience.
1+ year of professional experience (internships and part-time work welcome).
The expected base salary for this position is between $65,000 and $125,000 annually, depending on relevant experience and qualifications.
Equal Opportunity Statement
Don Lee Farms is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by law. Employment is contingent upon completion of a background check and verification of eligibility to work in the United States.
Principal Clinical Research Scientist - Surgical Implants Vision
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:
Scientific/Technology
All Job Posting Locations:
Irvine, California, United States of America, Milpitas, California, United States of America
Job Description:
About Vision
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 on the possibilities of vision treatments? Ready to join a team that's reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs - from the pediatric to aging eye - in a patient's lifetime.
Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech
We are searching for the best talent for a Principal Clinical Research Scientist - Surgical Implants Vision platform. The role is based on either the Irvine, CA or Milpitas, CA campuses.
Purpose: The Principal Clinical Research Scientist - Surgical Implants Vision platform is an expert in ophthalmic and medical device research who is a core team member on key projects. Your insights will drive the strategic direction for crafting clinical programs that generate scientific evidence to bring new technologies to eye care professionals and their patients. You should have an in-depth understanding of clinical research (science and execution), as well as familiarity with new product development, design control, and ophthalmic device regulations. A good grasp of related healthcare markets and clinical trends is also beneficial. You demonstrate a consistent track record as a key leader and contributor in complex projects, who delivers as promised. Be able to independently build collaborative relationships, influence and align with your functional partners, prioritize multiple projects, and delegate when efficient.
You will be responsible for:
Represent Clinical Science as core team member on critical projects, liaising between project and functional teams, and coordinating with Clinical Operations and Project Management partners to deliver on time, within budget, and in compliance with regulations and SOPs
Activate and build collaborative relationships with across business platforms as well as key cross-functional partners (e.g., Global Strategic Marketing, Medical Affairs, Regulatory Affairs, R&D, etc.) to ensure consistent alignment in new product development and through product life cycle
Lead initiatives for appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports, abstracts, manuscripts, and MDR-related documents (CER, PMCF, Clinical Plans, etc.)
Contribute to clinical scientific discussions with regulatory agencies that support the clinical and regulatory strategy, including proposed investigations, review process of evidence to support marketing authorization, and support of regulatory inspections
Engage and collaborate with industry's key opinion leaders, including KOLs and regulatory agencies, and build on relationships established through professional/technical societies
Performs other related duties as assigned by management
Qualifications
An advanced degree in a Scientific Field is required. A Doctoral Degree-Optometry or MD with specialty in Ophthalmology is highly recommend.
Other: Post-graduate degree or residency is preferred
Minimum of 8 years of relevant clinical / scientific work experience, including leadership functions (ie. leading or mentoring teams, non-managerial leadership experiences) is required
Experience with intraocular lenses is preferred.
Strong technical writing ability, such as clinical study protocols, reports and abstracts is required
Understanding of biostatistics as applied to study data is required
Proficient with computers and software programs is required
Ability to travel 10% of the time is required.
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.
#LI-VY1
#LI-Hybrid
Required Skills:
Preferred Skills:
Clinical Evaluations, Coaching, Critical Thinking, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Leadership, Medicines and Device Development and Regulation, Organizing, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Standard Scientific Processes and Procedures, Strategic Change, Study Management
The anticipated base pay range for this position is :
$117,000.00 - $201,250.00
For Bay Area:
$134,000.00 - $231,150.00
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
Auto-ApplyPrincipal Clinical Research Scientist - Surgical Implants Vision
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:
Scientific/Technology
All Job Posting Locations:
Irvine, California, United States of America, Milpitas, California, United States of America
Job Description:
About Vision
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 on the possibilities of vision treatments? Ready to join a team that's reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs - from the pediatric to aging eye - in a patient's lifetime.
Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech
We are searching for the best talent for a Principal Clinical Research Scientist - Surgical Implants Vision platform. The role is based on either the Irvine, CA or Milpitas, CA campuses.
Purpose: The Principal Clinical Research Scientist - Surgical Implants Vision platform is an expert in ophthalmic and medical device research who is a core team member on key projects. Your insights will drive the strategic direction for crafting clinical programs that generate scientific evidence to bring new technologies to eye care professionals and their patients. You should have an in-depth understanding of clinical research (science and execution), as well as familiarity with new product development, design control, and ophthalmic device regulations. A good grasp of related healthcare markets and clinical trends is also beneficial. You demonstrate a consistent track record as a key leader and contributor in complex projects, who delivers as promised. Be able to independently build collaborative relationships, influence and align with your functional partners, prioritize multiple projects, and delegate when efficient.
You will be responsible for:
Represent Clinical Science as core team member on critical projects, liaising between project and functional teams, and coordinating with Clinical Operations and Project Management partners to deliver on time, within budget, and in compliance with regulations and SOPs
Activate and build collaborative relationships with across business platforms as well as key cross-functional partners (e.g., Global Strategic Marketing, Medical Affairs, Regulatory Affairs, R&D, etc.) to ensure consistent alignment in new product development and through product life cycle
Lead initiatives for appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports, abstracts, manuscripts, and MDR-related documents (CER, PMCF, Clinical Plans, etc.)
Contribute to clinical scientific discussions with regulatory agencies that support the clinical and regulatory strategy, including proposed investigations, review process of evidence to support marketing authorization, and support of regulatory inspections
Engage and collaborate with industry's key opinion leaders, including KOLs and regulatory agencies, and build on relationships established through professional/technical societies
Performs other related duties as assigned by management
Qualifications
An advanced degree in a Scientific Field is required. A Doctoral Degree-Optometry or MD with specialty in Ophthalmology is highly recommend.
Other: Post-graduate degree or residency is preferred
Minimum of 8 years of relevant clinical / scientific work experience, including leadership functions (ie. leading or mentoring teams, non-managerial leadership experiences) is required
Experience with intraocular lenses is preferred.
Strong technical writing ability, such as clinical study protocols, reports and abstracts is required
Understanding of biostatistics as applied to study data is required
Proficient with computers and software programs is required
Ability to travel 10% of the time is required.
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.
#LI-VY1
#LI-Hybrid
Required Skills:
Preferred Skills:
Clinical Evaluations, Coaching, Critical Thinking, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Leadership, Medicines and Device Development and Regulation, Organizing, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Standard Scientific Processes and Procedures, Strategic Change, Study Management
The anticipated base pay range for this position is :
$117,000.00 - $201,250.00
For Bay Area:
$134,000.00 - $231,150.00
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
Auto-ApplySr. Clinical Research Finance Coordinator Post-Award - The Angeles Clinic & Research Institute
Clinical research coordinator job in Los Angeles, CA
Company DescriptionJobs for Humanity is partnering with CEDARS-SINAI to build an inclusive and just employment ecosystem. Therefore, we prioritize individuals coming from the following communities: Refugee, Neurodivergent, Single Parent, Blind or Low Vision, Deaf or Hard of Hearing, Black, Hispanic, Asian, Military Veterans, the Elderly, the LGBTQ, and Justice Impacted individuals. This position is open to candidates who reside in and have the legal right to work in the country where the job is located.
Company Name: CEDARS-SINAI
Job Description
Grow your career at Cedars-Sinai!
The Angeles Clinic & Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and expertly guiding and training the next generation of clinicians. Our board-certified fellowship-trained medical oncologists, surgeons, immunotherapists, pathologists, and dermatologists work closely together to advance cancer care. We are committed to bringing innovative therapeutic options to all of our patients with cancer!
Join our team and contribute to groundbreaking research!
Job Summary:
This position functions as a Sr. Clinical Research Finance Coordinator, responsible for coordinating and executing the financial billing of clinical trials, formation of the Medicare Coverage Analysis grid, and the development of clinical trial budgets. He/She is responsible for the calculation of statistical, fiscal, and metric data as it relates to clinical trial activities. The Sr. CRFC also assures the building of budgets/contract agreements within the Clinical Trial Management System (CTMS). This individual will interact with principal investigators, subjects, clinic and research staff, laboratory staff, medical
professionals, pharmaceutical staff, and Sponsor representatives to successfully oversee the research billing aspects of the
Medical Care Foundation.
Primary Duties and Responsibilities
• Develops and updates Medicare Coverage Analysis grids in order to assess which procedures/services within the protocol
are covered under Medicare guidelines. Works in conjunction with Cedars-Sinai Industry Sponsored Research Office in
order to produce a final document.
• Routinely monitors and reconciles trial accounts to ensure timely deposit, correct allocation, and distribution of revenue.
• Provides financial related data as needed, to internal team members and/or manager/director.
• Work with Accounts Payable to process and monitor that timely payments are made to various internal groups, external
partners, patients, and/or joint sites according to contractual/budgetary agreement.
• Responsible for accurate and timely fiscal data collection, documentation, entry and reporting into CTMS, including timely
response to sponsor communication.
• Develop and maintain statistical and fiscal reports as they relate to clinical trial activity on a monthly and fiscal year
basis.
• Process timely invoices which follow protocol driven procedures according to patient accruals/visits in order to seek
reimbursement from industry sponsors.
• Oversees and monitors billing work queue within the Electronic Medical Records system (EPIC) and adjudicates patient
bills according to final contract/budget.
• Critically evaluates research protocols to assess resource needs; assessment includes all research procedures, clinical
research staff time, investigator time, and costs from ancillary departments.
• Develops clinical trial budgets and negotiates with industry sponsors. Renegotiates budgets as part of trial maintenance
through amendments.
• Creates and finalizes payment terms (contract language) in conjunction with industry sponsor.
• Ensures compliance with all federal and local agencies including the FDA and IRB Maintains strict patient confidentiality
according to HIPAA regulations and applicable law.
• Perform other duties as assigned
Educational Requirements:
High School Diploma/GED (Minimum)
Bachelor's Degree (Preferred)
2 years Clinical research budgeting/billing required
CCRP - Certification In Clinical Research preferred
Physical Demands:
Perform continuous operation of a personal computer for four hours or more.
Use hands and fingers to handle and manipulate objects and/or operate equipment.
Working Title: Sr. Clinical Research Finance Coordinator Post-Award - The Angeles Clinic & Research Institute
Department: Angeles Research
Business Entity: Cedars-Sinai Medical Care Foundation
Job Category: Academic/Research
Job Specialty: Contract & Grant Budgeting/Funding
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day
Base Pay:$28.52 - $44.21
Clinical Research Associate 1
Clinical research coordinator job in Los Angeles, CA
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1 -2 years of clinical research experience or equivalent experience or training
Strong attention to detail
Ability to multi -task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self -motivated, assertive, and driven
BenefitsDental, Medical, Vision, PTO and 401K
Clinical Research Associate I - Integrative Oncology
Clinical research coordinator job in Irvine, CA
Clinical Research Associate I - Integrative Oncology - (10032422) Description Join the forefront of groundbreaking research 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.
Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.
A Clinical Research Associate I role is available for the Integrative Oncology research program within the Cherng Family Center.
You will be scheduling patients for biospecimen repository consents, screening, orientation and educational classes.
You will be traveling throughout the network to meet and consent patients.
As a successful candidate, you will:· Conduct protocol management for an assigned set of multiple research protocols.
· Conduct background check research, write and develop new clinical research protocols under the guidance of a medical oncology physician· Maintain current and accurate protocol documentation· Complete and maintain regulatory documents for IRB, DSMB and PRMC/CPRMC· Recruit patients to study and establish and maintain relationships with patients, visitors and other hospital personnel, while assuring confidentiality of patient information· Compile and submit data on appropriate forms according to protocol requirements· Collect and deliver specimens for analysis using specified equipment and ensure proper labeling.
Qualifications Your qualifications should include:· Associates degree.
Experience may substitute for minimum education requirements.
Bachelors preferred.
· One year of experience working in a health care setting, preferably in clinical research· Experience with medical record review, health information systems, and/or clinical trials is preferred· Superb communication and problem-solving skills and able to function independently and proficiently· Demonstrable computer skills in Microsoft Word, Excel, and/or Microsoft Access as well as skills in data management and analyses.
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 Comprehensive Benefits, please CLICK HERE.
Primary Location: United States-California-IrvineJob: Clinical ResearchWork Force Type: OnsiteShift: DaysJob Posting: Nov 6, 2025Minimum Hourly Rate ($): 33.
000000Maximum Hourly Rate ($): 41.
554100
Auto-ApplyClinical Research Associate I-CA Heart Foundation - Beverly Hills, CA
Clinical research coordinator job in Beverly Hills, CA
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
The California Heart Center is an affiliate of the Cedars-Sinai Heart Institute, located in Beverly Hills, California, 90211. We offer the full spectrum of cardiology care, including, Cardiac Evaluation/Adult Cardiology, Heart Failure Management, Interventional Cardiology, Nuclear Cardiology and Echocardiography.
In addition to our private cardiology practice, CA Heart Center physicians are active clinical research investigators and hold leadership positions in heart failure, heart transplantation, and mechanical cardiac assist devices and heart failure/transplant clinical research at the Cedars-Sinai Heart Institute (CSHI). In addition to its highly-regarded cardiology program, CSHI is doing groundbreaking work in other important cardiovascular areas, including cardiac stem cell transplants and non-surgical heart valve replacements. In partnership with CSHI, the California Heart Center offers a multi-disciplinary and integrated approach to the care of patients with heart disease.
Why work here?
Beyond an outstanding benefits package and competitive salaries, we take pride in hiring the best, most committed employees. Our staff reflects the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a multifaceted, inclusive environment that fuels innovation and the gold standard of care we strive for.
Are you ready to be a part of breakthrough research?
The Clinical Research Associate I works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports research objectives through tasks like data collection, candidate evaluation, participant scheduling, IRB assistance, budget management, and regulatory compliance.
Primary Duties & Responsibilities:
Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
Evaluates and abstracts clinical research data from source documents.
Ensures compliance with protocol and overall clinical research objectives.
Completes Case Report Forms (CRFs).
Enters clinical research data into Electronic Data Systems (EDCs) that the sponsors provide.
Provides supervised patient contact or patient contact for long term follow-up patients only.
Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Assists with clinical trial budgets.
Assists with patient research billing.
Assists with prescreening of potential research participants for various clinical trials.
Schedules patients for research visits and research procedures.
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Additional Qualifications/Responsibilities
Qualifications
Education:
High School Diploma/GED is required. Bachelor's degree in Science, Sociology, or a related field preferred.
Experience and Skills:
No experience required. One (1) year of clinical research related experience is preferred.
Ability to interpret and apply knowledge of State, Federal, and Agency standards to align with regulations.
Ability to convey and/or receive written/verbal information to/from various audiences in different formats.
Minimum Salary
21.29
Maximum Salary
33.00
Senior Clinical Research Coordinator (CRC)
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 Clinical Research Coordinator (Liver Trials)
Job Type: Full\-Time | On\-Site
Job Location: Orange, CA
Job Salary: $90,000\-$100,000 per year (based on experience)
Industry: Clinical Research | Hepatology | Phase I-IV Trials
About Us:
We're a fast\-paced, compliance\-driven research clinic 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 Clinical Research Coordinator (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 Clinical Research Coordinator) (Preferred)
• CCRP (Certified Clinical Research 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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Senior Clinical Research Coordinator
Clinical research coordinator job in Long Beach, CA
Job Description
We are seeking a highly organized and motivated Senior Clinical Research Coordinator (CRC) to join our research team. The CRC will coordinate and support all aspects of clinical trials and research studies, including subject recruitment, data collection, regulatory compliance, and specimen handling. Candidates with current Phlebotomy certification or Medical Assistant (MA) certification are strongly preferred, as this role may include specimen collection and basic clinical procedures.
Key Responsibilities:
Coordinate day-to-day clinical research activities to ensure study protocols are followed.
Recruit, screen, and enroll study participants.
Obtain informed consent and ensure ethical conduct in all study interactions.
Collect, process, and ship biological specimens per protocol (e.g., blood draws, urine samples).
Perform basic clinical procedures as permitted by certification (e.g., vital signs, EKGs).
Maintain accurate and timely documentation in case report forms and electronic databases.
Communicate with sponsors, monitors, and IRBs regarding study progress and compliance.
Schedule participant visits and follow-ups; ensure visit windows are met.
Ensure proper storage, handling, and accountability of investigational products, if applicable.
Maintain regulatory documents and assist with IRB submissions.
Qualifications:
Bachelor's degree in a health-related field or equivalent experience.
At least 1-2 years of experience in clinical research preferred.
Phlebotomy certification or MA certification preferred.
Knowledge of Good Clinical Practice (GCP) and regulatory guidelines.
Excellent organizational skills and attention to detail.
Strong interpersonal and communication skills.
Proficiency in Microsoft Office and electronic data capture systems (e.g., REDCap, EDC platforms).
Ability to work independently and as part of a multidisciplinary team.
Preferred Qualifications:
Experience working in clinical trials, especially in a hospital or academic setting.
Familiarity with IRB processes and clinical trial documentation.
Bilingual skills (depending on patient population) may be a plus.
Job Type: Full-time
Work Location: In person
Schedule:
8 hour shift
Monday to Friday
Weekends as needed
Senior Clinical Research Coordinator
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 clinical research 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 clinical research 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 Clinical Research! 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 Clinical Research Coordinator/Clinical Research Coordinator III for our Artemis Institute of Research clinical trial site located in Riverside, California. Under the supervision of the Site Director, the Senior Clinical Research Coordinator is responsible for the conduct of research protocols, such that the integrity and quality of the clinical research is maintained and the research is conducted in accordance with Good Clinical Practice Guidelines. The Senior Clinical Research Coordinator 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 Clinical Research Coordinator 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
Auto-ApplySr. Clinical Research Coordinator
Clinical research coordinator job in Los Angeles, CA
Job Description
Orso Health is a leading organization in clinical research, dedicated to advancing healthcare through innovative studies. We are committed to excellence in research and invite you to be part of our dynamic team. California and the Arizona market. Known for our high standards of excellence, we are committed to providing compassionate, patient-centered care for both pediatric and adult patients. Our dedicated team strives to improve lives through the expert diagnosis and treatment of a wide range of allergy and asthma conditions. We are looking for high-energy, kind, and collaborative individuals who are eager to grow personally and professionally to join our team.
Position Summary
We are seeking a dedicated and experienced Senior Clinical Research Coordinator (CRC) to join our team. The ideal candidate will play a key role in managing clinical trials across multiple sites, ensuring compliance with regulatory requirements and study protocols while maintaining the highest standards of participant safety and data integrity. The position requires regular travel to study sites, making it essential for the candidate to be adaptable and organized. This role is non-exempt (hourly) and full-time, working 40 hours per week, Monday through Friday in our Torrance office.
Key Responsibilities
Site Management: Oversee the day-to-day operations of clinical trials at various sites, ensuring adherence to study protocols, regulatory compliance, and good clinical practice (GCP).
Training & Mentorship: Provide training and support to junior CRCs and site staff, fostering a collaborative environment and ensuring proficiency in study procedures.
Participant Interaction: Engage with study participants, including recruitment, informed consent, and addressing any questions or concerns regarding the study process.
Data Collection & Documentation: Ensure accurate and timely collection, documentation, and reporting of study data in accordance with regulatory guidelines and sponsor requirements.
Regulatory Oversight: Maintain all necessary regulatory documentation, including IRB submissions, regulatory binders, and serious adverse event (SAE) reporting.
Sponsor & Stakeholder Communication: Act as the primary point of contact between the sponsor, study sites, and internal teams, facilitating effective communication and resolution of any issues that arise.
Quality Assurance & Compliance: Participate in site visits and audits, ensuring compliance with all study protocols and regulations.
Additional duties as assigned.
Minimal travel required between sites across Southern California (LA & SD) and Arizona
Qualifications & Requirements
Education: Bachelor's degree in a related field (e.g., life sciences, nursing, or similar).
Experience: Minimum of 5 years of experience in clinical research, with at least 2 years as a Clinical Research Coordinator. Experience in a variety of therapeutic areas is a plus.
Licensure & Certifications: Preferred Certification in clinical research (e.g., ACRP or SOCRA certification).
Skills & Abilities:
Strong knowledge of GCP, FDA regulations, and clinical trial processes.
Excellent organizational skills and attention to detail, with the ability to manage multiple projects simultaneously.
Strong communication and interpersonal skills, capable of working collaboratively with diverse teams.
Proven ability to work independently and handle challenging situations effectively.
Proficient in using clinical trial management systems (CTMS) and electronic data capture (EDC) tools.
Compensation
The hourly range for this position is $36.00-40.00/hour. The actual compensation for this role will be determined by a variety of factors, including but not limited to the candidate's skills, education, and experience.
Physical Requirements
Ability to stand, walk, and move throughout the clinic, if applicable, for extended periods; occasionally lift objects up to 25 lbs., bend, stoop, or reach as needed. Frequent use of hands and fingers for patient care and equipment operation. Must have normal (or corrected) vision and hearing and be able to respond quickly in a fast-paced clinical environment, if applicable.
What We Offer
Competitive salary and benefits package, including medical, dental & vision insurance, 401(k) retirement plan with employer matching, and professional development opportunities
In addition, we offer paid time Off (PTO), sick time, floating holiday and holiday pay
Opportunity to shape the future of cutting-edge clinical research in beautiful San Diego (and across our expanding network)
An opportunity to play an active role in medical advancement
If this role excites you, please submit your resume and a cover letter outlining your relevant experience and why you're passionate about joining our team. We look forward to hearing from enthusiastic candidates ready to drive our success!
California Consumer Privacy Act (CCPA) Notice
Orso Health ("OH") complies with the California Consumer Privacy Act ("CCPA"). Personal information provided in the job application process will be collected, used, and retained in accordance with applicable privacy laws. Candidates may request additional information regarding the categories of personal information collected and the purposes for which it is used during the hiring process.
Travel Clinical Research Coordinator
Clinical research coordinator job in Los Angeles, CA
Job Description
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 into 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 clinical research 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 Travel Clinical Coordinator primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. Due to enhanced experience in Care Access' decentralized clinical research process, the Travel Clinical Coordinator will be able to assume a greater study workload, overall study responsibility, and more detailed, Site, Sponsor and CRO interactions, while conveying a positive image of Care Access Research to the community, Sponsors, CROs, and study participants and their family members.
The Travel Clinical Coordinator is proficient at ICH/GCP, Good Documentation Practices (GDP), and ALCOA-C+. The travel clinical research coordinator role is a mid-level position where the individual has strong working knowledge and experience in the clinical research industry and can perform their duties independently with little day to day guidance from their managers. The Travel Clinical Coordinator will be mentored by their CRC Lead, Site Manager, Senior Manager, and other leaders within clinical operations.
How You'll Make An Impact
Study Preparation:
Ability to understand and follow institutional SOPs
Review and assess protocol, study manuals, and the investigator drug brochure (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc.
Assist PI, Regulatory, Start-up and the Clinical Trial Manager(s) to ensure that all training and study requirements are met prior to trial conduct
Discuss study medication, required procedures, eligibility criteria and impact on clinic flow with your manager, Investigator, and site staff
Assist with planning and creation of appropriate recruitment and marketing materials
Assist in development of recruitment plan and obtain listing of potential candidates to contact from an internal subject database like StudyTeam, CRIO, etc.
Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies
Attend Investigator meetings as requested/required and/or coordinate/attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives
Assist in the creation or review of protocol specific source documents
Determine facility, equipment and outsource vendor requirements and availability
Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) and study maintenance
Ensure education of Assistant CRCs, research assistants, site staff and/or sub-investigators is completed for required tasks
Study Management:
Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines and participant safety.
Maintain organized file for source documents, patient charts, CRFs, regulatory and study supplies
Where appropriate, Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document on accountability log and patient records
Collect and evaluate concomitant medications
Collect, process, and ship biological specimens as directed by protocol and/or laboratory manual.
Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings
Ensure trial activities are continuously discussed with covering personnel in preparation of vacation or sick leave
Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of Care Access Research team in an ongoing fashion
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
Strong and clear communication skills, both verbally and in writing
Accept accountability for actions and function independently
Patient Coordination:
Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment
Obtain informed consent per Care Access Research SOP and document process when revised ICF discussed with patient during course of the trial
Administer delegated study questionnaires, where appropriate.
Collect and evaluate medical records with the support of medically qualified members of the study team.
Complete visit procedures and ensure proper specimen collection, processing and shipment 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
Proficient at recognizing adverse events (AEs) and Serious Adverse Events (SAEs)
Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol
Schedule patients within visit windows, notify personnel as needed for procedures and integrate visits with existing schedules to maximize efficient workflow and patient turnaround
Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance.
Monitor patient progress on study medication
Documentation:
Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP
Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion.
Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart
Accurately transcribe data to CRF or EDC.
Resolve data management queries and correct source data as needed
Record protocol exemptions and deviations as appropriate with sponsor.
Complete Note(s)-to-File for patient chart and regulatory filing if necessary
Ensure all sponsor correspondence (e-mail, telephone conversations) are printed and given to appropriate personnel for regulatory filing
Maintain copies of patient-specific correspondence in source charts
Assist regulatory personnel with completion of continuing/final review reports
Perform other duties as assigned.
The Expertise Required
Excellent working knowledge of clinical trials, medicine and research terminology
Excellent working knowledge of federal regulations, good clinical practices (GCP), good documentation practices (GDP), and ALCOA-C+
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.
Proficiency with technology used to support the clinical trial industry. CTMS systems like CRIO, clinical conductor, Clinical Ink; EDC systems like MediData, Oracle, and Inform; ePRO, eConsent and IWRS/IXRS, etc.
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:
BS in nursing, pharmacy or other related science or combination of equivalent education preferred in the Arts or Sciences preferred
RN or LPN preferred
Research Professional Certification- CRCC or exam eligibility preferred
A minimum of 3 to 4 years Clinical Research experience
A minimum of 2 years prior Clinical Research Coordinator experience, management level preferred.
How We Work Together
Location: This position is for a full-time temporary, hourly role. The duration is 12-months from the decision to hire. Candidates must be willing to travel 75% of the time nationwide.
Travel: Duties may require travel in the following models:
Two weeks on / One week off deployments
Temporary Event Support (3-7-day deployment durations)
Weekly deployments (one week on, 2-5 days off).
Frequency and length of travel may depend on the length and location of study, site, and event.
Deployments normalize to a 32 to 42-hour work week on average.
The expected salary range for this role is $70,000-$100,000 USD per year. In addition to base pay, employees may be eligible for 401k, stock options, health and wellness benefits and paid time off.
Benefits & Perks (US Full Time Employees Only)
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: ********************************
Clinical Research Coordinator
Clinical research coordinator job in Los Angeles, CA
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 Clinical Research Coordinators at our Century City, Los Angeles site location. This is one of our three oncology research sites in the Greater Los Angeles area. These locations are formerly Valkyrie Clinical Trials - we are proud to welcome Valkyrie Clinical Trials to the Flourish Research network!
The Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research 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 10-12 hour days, overnights, and weekends)
*You will always have advanced notice for longer shifts, overnights, or weekends
Location: 2080 Century Park E, Suite 803, Los Angeles, CA 90067
Compensation: $72,000 - $79,000 ($34.60 - $37.98/hr) + overtime pay
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
Must have oncology clinical research experience
Minimum of two years of clinical research 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.
Auto-ApplyExperienced Clinical Research Coordinator (Inglewood)
Clinical research coordinator job in Inglewood, CA
Job DescriptionInglewood Clinical is part of the Irvine Clinical Research site network, the largest of its kind on the West Coast. With 5 research centers in California, we are leaders in the search for new treatments in neurology, psychiatry, and obesity medicine. Our largest area of research is in Alzheimer's Disease prevention and treatment drug trials, and our doctors were the largest contributors in the world to the most recently FDA-approved medication in Alzheimer's Disease.
In this role, we are seeking CRCs with proven trial experience. Ideally, candidates will have worked as a primary coordinator on a high-enrolling and/or highly complex drug trial and produced quality work.Job Duties
Manage daily operations for assigned clinical trial projects
Perform study procedures in accordance with GCP and study protocols
Organize and maintain paper and electronic study data in a complete and correct manner
Cultivate enthusiastic and professional relationships with patients and sponsors alike
Work closely with recruitment and prescreening teams to meet study enrollment goals
Conduct diagnostic, efficacy, and safety assessments as needed
Job Requirements
Two (2) or more years of clinical research coordinator experience
Attention to detail and the ability to handle multiple tasks with precision
Demonstrated ability to work accurately and quickly with CTMS
A command of professional spoken and written English
Hours and CompensationThis is a full-time employment position based in-person at our clinic next to Centinela Hospital in Inglewood. It is in a large, safe medical building with ample parking and walking distance to SoFi Stadium.
The estimated salary for this position is between $71k-$80k per year, depending on experience and education.
The company pays for 100% of health/dental/vision individual insurance costs for eligible full-time employees. Vacation (PTO) is earned at a rate of 3 weeks per year.
Clinical Research Coordinator
Clinical research coordinator job in Anaheim, CA
Job Description
Responsibilities
Artificial Intelligence; Advanced Technology; The very best in patient care. With decades of expertise, we are
Radiology Forward
. With dynamic cross-training and advancement opportunities in a team-focused environment, the core of our success is its people with the commitment to a better healthcare experience. When you join us as a
Clinical Research Coordinator,
you will be joining a dedicated team of professionals who deliver quality, value, and access in the 21st century and align all stakeholders- patients, providers, payors, and regulators to achieve the best clinical outcomes.
You Will:
Works with broad spectrum of health care providers for many disease types, physicians, nurses, other research coordinators, imaging techs and support staff
Read and interpret research study protocols in order to define the procedures that will be provided to the clinical research site
Translate the designated study procedures into a plan for operational implementation
Must be able to articulate study process and produce study flow and source documents that are instructive to the technical and clerical staff
Maintain impeccable records of all interactions with clients and companies
Assures confidentiality of patient's records and study related materials that are provided under non-disclosure agreements by the research site, pharmaceutical company, or imaging vendor
Assist the scheduling team with any problems or difficulties to achieve patient study time lines
Maintains accurate study files
Provides each imaging site with binders and assists them with relevant information in order to procure correct imaging for each study
Visits multiple imaging centers in California to ensure training and study compliance.
Attends on site pre study and site initiation visits as needed
Adjusts schedule to ensure site visits and training sessions can be accomplished
Must be able to problem solve and resolve data queries in a timely manner
Work environment is organized and functions efficiently
You Are:
Genuinely passionate about customer service and exercise sound judgement and an ability to remain professional in all situations
Able to demonstrate high level of attention to detail, excellent organizational skills and have the ability to multitask
Able to thrive in a fast-paced environment, have a knack for prioritizing work with a structured approach, and enjoy providing world class customer service
To Ensure Success In This Role, You Must Have:
High school graduate (some college preferred)
MA certificate, or at least 2 years in a clinical setting or imaging center
At least 2 years in a research environment with study operations responsibilities
Bachelor's degree or higher may substitute for experience
We Offer:
Comprehensive Medical, Dental and Vision coverages.
Health Savings Accounts with employer funding.
Wellness dollars
401(k) Employer Match
Free services at any of our imaging centers for you and your immediate family.