Clinical Research Associate jobs at Cedars-Sinai - 131 jobs
Clinical Research Associate I (Hybrid, Per Diem) - Thai & Asian Community Health Initiatives
Cedars-Sinai 4.8
Clinical research associate job at Cedars-Sinai
This is a hybrid per diem position offering flexibility to work between 0 and 40 hours per week, depending on departmental needs. Scheduling will be determined by the hiring manager in alignment with operational priorities. At this time, we can only consider applicants who are able to commute to our Los Angeles work location several times per week and who reside within a reasonable commuting distance.
The hybrid schedule typically consists of two remote workdays and three days spent either onsite or in the field, based on project and program requirements.
Preferred Qualification: Proficiency in the Thai language is strongly preferred.
Please note that per diem team members are not eligible for health benefits, but this role provides an excellent opportunity to gain valuable experience, contribute to meaningful work, and enjoy a flexible schedule.
Cedars-Sinai's Cancer Research Center for Health Equity (CRCHE) and Community Outreach & Engagement team are seeking a passionate and community-oriented ClinicalResearch Coordinator (CRC I) - Per Diem to support the implementation of the ASPIRE (Asian American Prospective Research) study. This important initiative focuses on advancing community-based research within the Thai community, helping to improve cancer prevention, screening, and health outcomes.
In this role, you will play a key part in developing community partnerships, engaging participants, and ensuring the successful implementation of ASPIRE's goals through culturally responsive outreach and collaboration.
The ClinicalResearchAssociate I works directly with a ClinicalResearch 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 clinicalresearch 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 and Responsibilities
Works with a ClinicalResearch Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
Evaluates and abstracts clinicalresearch data from source documents.
Ensures compliance with protocol and overall clinicalresearch objectives.
Completes Case Report Forms (CRFs).
Enters clinicalresearch data into Electronic Data Systems (EDCs) that are provided by the sponsors.
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.
Department Specific Duties & Responsibilities
5% - Works under the direction of a ClinicalResearch Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to support the coordination and implementation of non-complex research studies.
5% - Collects, evaluates, and abstracts clinicalresearch data; may assist in designing data collection/abstraction tools. Enters and processes clinicalresearch data into sponsor-provided Electronic Data Capture (EDC) systems.
5% - Completes Case Report Forms (CRFs) in accordance with study protocols and sponsor requirements.
5% - Assists with prescreening potential research participants for various clinical trials. Schedules participants for research visits and procedures. Provides supervised patient contact or independent contact for long-term follow-up participants.
5% - Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB), including the submission of Adverse Events, Serious Adverse Events, and Safety Letters per federal and local guidelines.
5% - Assists with clinical trial budgets, study-related billing, and patient research billing activities.
5% - Prepares and ships biological samples; maintains study supplies, kits, and inventory.
5% - Ensures compliance with study protocols, Good Clinical Practice (GCP), FDA regulations, IRB requirements, HIPAA standards, and all institutional and federal guidelines. Maintains strict patient confidentiality.
5% - Serves as a point of contact for external sponsors for select trials; responds to sponsor inquiries and may attend meetings regarding study activity under supervision.
Additional Study-Specific Duties
Pulmonary Function Lab
Assists with prescreening of potential study participants.
Maintains organized paper and electronic research files.
Assists with preparing manuscripts, correspondence, and other research documents.
Conducts literature reviews to support study activities.
Neuroscience
Transports research medications according to protocol requirements.
Performs study-related assessments and participant questionnaires.
Maintains organized paper and electronic research files.
Assists with manuscript preparation and other research documentation needs.
Conducts literature reviews for ongoing and upcoming studies.
QualificationsRequirements:
High School Diploma/GED required.
Preferred:
Bachelor's Degree preferred.
Proficiency in the Thai language is strongly preferred.
1 year Clinicalresearch related experience preferred.
Req ID : 13883
Working Title : ClinicalResearchAssociate I (Hybrid, Per Diem) - Thai & Asian Community Health Initiatives
Department : Cancer - Research Center Health Equity
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
$24-32.9 hourly 21h ago
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Research Associate II - The Angeles Clinic & Research Institute
Cedars-Sinai 4.8
Clinical research associate job at Cedars-Sinai
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 our patients with cancer.
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.
Join our team and contribute to groundbreaking research.
The ResearchAssociate II works at a high level of excellence and commitment to perform a wide variety of activities integral to the successful management and administration of essential regulatory documents. The ResearchAssociate II is responsible for ensuring timely submission of complete, accurate and current documents to research sponsors, IRBs, and contract research organizations, where applicable.
Primary Duties and Responsibilities:
Submits research projects (protocols, consent forms, recruitment materials, IRB application, etc.) for human subjects' approval.
Submits appropriate internal documentation for contract execution. Maintains communication with contracting officers and sponsors of research during the budgeting and negotiating process.
Develops research project budgets based on protocol requirements and Cedars-Sinai published research costs, ensuring that all anticipated costs are appropriately accommodated and that research protocol, research budget and research subject informed consent documents are consistent.
Monitors study payments and generates invoices as necessary to ensure adequate funding throughout the course of the trial.
Ensures timely filing of annual renewals and amendment submissions to IRB.
Ensures the completion and maintenance of consent forms, case report forms, SAE's and source documents to ensure that research is being conducted according to IRB, FDA, OHRP, HIPAA and other agency guidelines.
Maintains high quality, up-to-date regulatory files (CITI and other training documents, financial disclosures, FDA forms, CVs, medical licenses, etc.) for research studies.
Completes appropriate IRB paperwork and submits internal and external Serious Adverse Events (SAEs) and INDSRs to IRB.
May help coordinate and prepare for institutional, pharmaceutical and internal audits.
Coordinates site feasibility visits and site initiation visits for potential studies. Completes feasibility questionnaires.
Provides facility tours to visiting research sponsors, CROs, and other personnel for research-related activities.
Coordinates and collaborates with internal and external investigators and participating centers in multi-center studies to achieve research goals.
Participates in weekly research staff meetings.
Protects rights and research data of research volunteers, including medical records, data, etc. Obtains necessary consent forms, or HIPAA information forms as needed, in research process.
Performs administrative duties in a timely manner as assigned.
Qualifications
Requirements:
High School Diploma/GED required. Bachelor's degree preferred.
1 year Clinicalresearch related experience required.
#Jobs-Indeed
#LI
Req ID : 13668
Working Title : ResearchAssociate II - The Angeles Clinic & Research Institute
Department : Angeles Research Inst
Business Entity : Cedars-Sinai Medical Care Foundation
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $24 - $34.64
$24-34.6 hourly 21h ago
Clinical Research Associate I - Women's Research Program - Full-Time, On-Site
Cedars-Sinai 4.8
Clinical research associate job at Cedars-Sinai
Come join our team!
The ClinicalResearchAssociate I works under the direction of a ClinicalResearch Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines.
What are the Primary Duties and Responsibilities?
Works under the direction of a ClinicalResearch Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies.
Collects, evaluates and/or abstracts clinicalresearch data. May assist in designing forms for data collection/abstraction. Enters and processes clinicalresearch data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Completes Case Report Forms (CRFs).
Assists with prescreening of potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. Provides supervised patient contact or independent patient contact for long term follow-up patients only.
Assists supervising staff 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 and patient research billing.
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
Ensures compliance with protocol and overall clinicalresearch objectives. 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.
May serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.
Qualifications
Education, Experience, & Skills Requirements:
High School Diploma / GED required. Bachelor's Degree in Science, Sociology or related degree preferred.
One (1) year of clinicalresearch related experience preferred.
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 : 14611
Working Title : ClinicalResearchAssociate I - Women's Research Program - Full-Time, On-Site
Department : Womens Cancer Program - WCP
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 : $24.00 - $32.86
$24-32.9 hourly 19h ago
Clinical Research Associate I - Medically Associated Science & Technology (MAST) Program
Cedars-Sinai 4.8
Clinical research associate job at Cedars-Sinai
When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai.
We invite you to consider this phenomenal opportunity!
As a ClinicalResearchAssociate I, you will work under the direction of a ClinicalResearch Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of non-complex research studies. The incumbent will support objectives of research studies through non-complex tasks such as data collection, pre-screening and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines.
Primary Job Duties and Responsibilities:
Collects, evaluates and/or abstracts clinicalresearch data.
May assist in designing forms for data collection/abstraction.
Enters and processes clinicalresearch data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Completes Case Report Forms (CRFs).
Schedules research participants for research visits and research procedures.
Provides supervised patient contact or independent patient contact for long term follow-up patients only.
Assists supervising staff 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 and patient research billing.
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
Ensures compliance with protocol and overall clinicalresearch objectives.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
May serve as one point of contact for external sponsors for select trials.
May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.
Department-Specific Duties:
Maintains CITI certification.
Compiles, analyzes, and presents work at internal meetings and conferences.
Performs data searches and other related administrative tasks.
Assists with research protocol writing and development.
Assists with prescreening of research participants for various clinical trials.
Attends research meetings and monthly conference calls with sponsors.
Maintains organized paper and electronic research files.
Performs all data collection and data entry tasks for departmental clinical studies.
Assists with preparing manuscripts, letters, and other research documents as needed.
Coordinates study related activities and subject recruitment with Laboratory Staff.
Qualifications
Education:
High School Diploma/GED is required.
Bachelor's degree in Science, Sociology, or related degree is preferred.
Experience:
One year of clinicalresearch related experience is preferred.
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 : 13223
Working Title : ClinicalResearchAssociate I - Medically Associated Science & Technology (MAST) Program
Department : Associated Sci and Tech Program
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
$24-32.9 hourly 21h ago
Clinical Research Finance Coordinator III - Post Award
Cedars-Sinai 4.8
Clinical research associate job at Cedars-Sinai
This role offers a fully remote work arrangement. Please note that applicants must be based in California to be considered for this opportunity
This position is a post-award role, meaning the incumbent will support sponsored research projects after funding has been awarded. Responsibilities include financial management and oversight of active grants and contracts, such as monitoring budgets and expenditures, ensuring compliance with sponsor and institutional policies, processing financial transactions, preparing financial reports, and partnering closely with investigators and research teams to support the ongoing fiscal health of awarded studies. This role does not focus on proposal development or grant submission activities.
The ClinicalResearch Finance Coordinator III develops highly complex clinical trial budgets for industry, National Institutes of Health (NIH), and investigator-initiated clinicalresearch. Evaluates research protocols to assess resource needs, procedures, clinicalresearch staff time, investigator time, and costs from ancillary departments. Determines cost allocation, negotiates budgets, details budgets, and responsible for monitoring and invoicing. Plans and coordinates strategies for improving efficiency, action plans to improve quality, and training and education of personnel. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Primary Duties and Responsibilities
Works closely with investigators and ancillary departments to identify research procedures needed, budget estimates and cost details.
Evaluates highly complex research protocols to assess resource needs, research procedures, clinicalresearch staff time, investigator time, and costs from ancillary departments. Processes Ancillary Agreements with departments providing research services.
Determines whether research procedures in the protocol are standard-of-care or a research-related cost in order to correctly classify expenses.
Develops highly complex clinical trial budgets sponsored for industry and the National Institutes of Health (NIH), investigator-initiated clinicalresearch. Works with the CSMC office of Sponsored Research to develop final budgets for clinical trials and research projects. Reviews and approves internal and/or satellite site budgets.
Negotiates trial budgets and payment terms with industry sponsors.
Monitors study accounts to evaluate that cost expenses/details are appropriate and within expected limits, reconciles accounts receivable and payments, and determines the best course of action for any deficits and/or surpluses. Negotiates with sponsors the final payment due for account closeout. Conducts quality review and/or audits of clinical trial budgets. Serves as point of contact for fiscal related questions and engages management as appropriate.
Responsible for invoicing sponsors, patient research billing, reimbursement to ancillary departments, and payment tracking. Issues and submits invoices for protocol-related items and patient-related expenses per the executed contract and internal invoices for staff time and effort allocation into study accounts. Works closely with sponsors and clinical teams to resolve queries regarding invoices and/or payments due.
Extracts and defines relevant information, analyzes and interprets data to determine financial performance and/or to project a financial probability, and makes recommendations and/or creates proposals to influence business results. Prepares and delivers data, reports and/or presentations to investigators, management and/or leadership.
Enters financial information from finalized clinical trial budgets and clinical trial agreements into the Clinical Trial Management System. Reviews and finalizes study calendars to ensure agreement with Medicare coverage analysis and clinical trials budget.
Performs Medicare coverage analysis for clinical trials and collaborates with Institutional Review Board (IRB) to finalize and obtain approval.
Reviews protocol amendments for impact to sponsored research budget/contract. Processes budget/contract amendments as applicable.
Provides training, education, onboarding and mentors other personnel.
Plans and coordinates strategies to improve existing standard operating procedures related to budgeting and clinical trials finance. Identifies quality and performance improvement opportunities and work with management to lead the development of new (or improvement of existing) processes, policies or standard operating procedures. Assists with business software launches, implementation or optimization.
May lead or facilitate team meetings.
QualificationsRequirements:
High School Diploma/GED.
5 years of Experience with billing, accounting, accounting, finance, financial analysis or related field.
2 years of Experience in clinicalresearch.
Preferred:
Bachelors in Accounting, Finance, or other related degree
Req ID : 13660
Working Title : ClinicalResearch Finance Coordinator III - Post Award
Department : Cancer - SOCCI ClinicalResearch
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Contract & Grant Budget/Fund
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $41.42 - $70.41
$41.4-70.4 hourly 19h ago
Clinical Research Associate I - Yang Lab - Karsh Division of Gastroenterology and Hepatology
Cedars-Sinai 4.8
Clinical research associate job at Cedars-Sinai
When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai.
We invite you to consider this phenomenal opportunity!
Dr. Ju Dong Yang, in Department of Medicine, Karsh Division of Gastroenterology and Hepatology is looking for a new ClinicalResearchAssociate I to join the team!
The research program of Dr. Ju Dong Yang has been focused on clinical and translational research of liver cancer. Dr. Yang conducted several population-based cohort studies to describe recent trends in liver cancer epidemiology in the United States.
As a ClinicalResearchAssociate I, you will work directly with a ClinicalResearch Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. This role evaluates and abstracts research data and ensures compliance with protocol and research objectives. This position will be responsible for completing case report forms (CRFs), entering clinicalresearch data, and assisting with regulatory submissions to the Institutional Review Board (IRB). The CRA I member may have limited contact with research participants as needed for study and assists with study budget and research participant billing. This role follows all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Job Duties and Responsibilities:
Ensures compliance with protocol and overall clinicalresearch objectives.
Enters clinicalresearch data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Provides supervised patient contact or patient contact for long term follow-up patients only.
Assists with regulatory submissions to the Institutional Review Board (IRB) and works closely with supervising research staff or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Assists with clinical trial budgets and 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.
Department-Specific Responsibilities:
May serve as one point of contact for external sponsors for select trials.
May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.
Qualifications
Education:
High School Diploma/GED is required.
Bachelor's degree in Science, Sociology, or related degree is preferred.
Licenses/Certifications:
ACRP/SoCRA certification is preferred.
Experience:
Clinicalresearch experience is highly preferred.
Understanding of general research objectives.
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 : 13803
Working Title : ClinicalResearchAssociate I - Yang Lab - Karsh Division of Gastroenterology and Hepatology
Department : Research - General Medicine
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
$24-32.9 hourly 21h ago
Clinical Research Associate I - Community & Behavioral Health, Tan Lab (Onsite)
Cedars-Sinai 4.8
Clinical research associate job at Cedars-Sinai
This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace. Please note that hybrid or remote work options are NOT available for this position at this time.
Please note that a cover letter is required as part of the application. The cover letter should explain your interest in this opportunity and how it aligns with your career goals. Applications missing this document will not be considered.
Cedars-Sinai has an outstanding opportunity for an independent and well-organized contributor to serve as a CLINICALRESEARCHASSOCIATE to Dr. Judy Tan to support community-engaged research that develops behavioral and community-based health interventions for LGBTQ+ communities of color. Dr. Tan, Associate Professor, Cancer Research Center for Health Equity, Division of Population Sciences, Department of Biomedical Sciences, is a social psychologist and applies her training in behavioral and prevention sciences to develop innovative interventions for improving health outcomes among marginalized populations in the U.S.
This position provides contributions to behavioral and implementation science for the Cancer Research Center for Health Equity. The scope of the work includes research involving participants recruited from the surrounding LA communities and interactions with community-based researchers, academic researchers, and local community organizations and health systems.
As ClinicalResearchAssociate, you will be a vital member of an interdisciplinary team led by Dr. Tan, which includes a biostatistician, qualitative data researchers, as well as grant administrative and project management support staff members. Your role will be assisting with both quantitative and qualitative research projects, patient research engagement, and community liaison support. You will take lead roles on project activities, as identified by the team.
Data management, coordination, and analysis: (30%)
Assist with leading the creation and management of organized research project portfolio with project dashboard for data tracking.
Work independently to produce tables, charts, graphs for manuscript and grant preparation from sources including analyst reports, publicly available data, and literature searches.
Organize data storage and management for qualitative study (including interviews with cancer patients, caregivers, and affected community members).
Organize data storage and management for quantitative projects.
Execute basic data analysis (demographic tables, bivariate calculations, evaluation of missing data) of existing data sets to generate research approach and analytic plans.
Support process evaluation of a pilot smoking cessation program, including developing evaluation framework, creating and implementing a data collection plan.
Human subject research support: (20%)
Assist with leading the creation and management of study questionnaires in REDCap.
Identify and resolve quality issues with survey administration.
Manage revisions of REDCap instrument and protocol.
Triage data collection questions for immediate resolution or consultation with team, PI.
Assist with leading the development and submissions of IRB study applications, modifications, and renewals.
Assist with leading the compliance efforts for sponsoring entities.
Patient and stakeholder engagement: (20%)
Support the relationship (act as primary liaison) with community partners, through meeting scheduling, regular and proactive email communication, phone calls, and in-person meetings.
Support collaboration with community partners to develop and assess project implementation strategies, including outreach strategies, project materials, and workshop content.
Manage collaborative curriculum adaptation with multiple community partners.
Interact with patients via assisting with qualitative interviews and focus groups.
Writing & Grant Development (10%)
Assist with leading the development of project narrative/research plans for new grants, including timelines and schedules of deliverables.
Write portions of manuscripts in collaboration with the research team and community partners.
Provide copy-editing assistance with manuscripts.
Conduct independent literature searches and produce summaries to guide project development based on ongoing research findings and future steps.
Budget Management (5%)
Act as PI proxy in grant expense approvals and FTE certification.
Collaborate with department payroll and grant management staff to identify and address any expense errors.
Reconcile budgets monthly.
Create budget projections; identify budget surplus and deficits.
Ensure timely payment of community partner and other service provider invoices.
Assess appropriate budgets to charge for new research activities.
Website development & management (5%)
Develop content for website.
Edit content according to stakeholder (community partners') feedback)
Edit personal testimonial videos.
Respond to and track website inquiries.
Act as the primary liaison with graphic designer and web developers.
Other administrative duties as needed (5%)
Support Dr. Tan and project team with scheduling meetings
Plan and co-manage event logistics; act as primary liaison with on-site service providers.
Qualifications
This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace. Please note that hybrid or remote work options are NOT available for this position at this time.
Please note that a cover letter is required as part of the application. The cover letter should explain your interest in this opportunity and how it aligns with your career goals. Applications missing this document will not be considered.
Requirements:
High School Diploma or GED required
A cover letter explaining your interest in this opportunity and how it aligns with your career goals
Resume or CV
Preferred:
Bachelor's degree or equivalent experience in public health or related area.
At least 2 years of related experience post-undergraduate degree.
Excellent verbal and written communication skills.
Working knowledge of community-based research and organizing theories, frameworks, principles, and practices.
Experience with program evaluation, specifically process evaluation.
Experience managing complex, multi-stakeholder projects.
Experience working with marginalized populations related to health issues.
Strong interest in minority health & healthcare, racial disparities, social determinants of health with self- motivation for independent learning
Commitment to racial and LGBTQ+ justice.
Bachelor's level or equivalent analytic skills and understanding (SAS, Stata, R or equivalent).
Intermediate or higher level skills of MS Office suite.
Interview Process:
If selected for an interview, candidates may be asked to complete a brief writing sample and/or a short example exercise or task relevant to the position.
Req ID : 10622
Working Title : ClinicalResearchAssociate I - Community & Behavioral Health, Tan Lab (Onsite)
Department : Cancer - Research Center Health Equity
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
$24-32.9 hourly 21h ago
Clinical Research Associate I - CA Heart Foundation
Cedars-Sinai 4.8
Clinical research associate job at Cedars-Sinai
Grow your career at Cedars-Sinai!
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 clinicalresearch investigators and hold leadership positions in heart failure, heart transplantation, and mechanical cardiac assist devices and heart failure/transplant clinicalresearch 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 ClinicalResearchAssociate I works under the direction of a ClinicalResearch 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 ClinicalResearch Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
Evaluates and abstracts clinicalresearch data from source documents.
Ensures compliance with protocol and overall clinicalresearch objectives.
Completes Case Report Forms (CRFs).
Enters clinicalresearch 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.
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 clinicalresearch 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.
Req ID : 13782
Working Title : ClinicalResearchAssociate I - CA Heart Foundation
Department : CA Heart Foundation
Business Entity : Cedars-Sinai Medical Care Foundation
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $24 - $33
$24-33 hourly 21h ago
Clinical Research Associate I - Heart Institute - Makkar Lab
Cedars-Sinai 4.8
Clinical research associate job at Cedars-Sinai
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 ClinicalResearchAssociate I works under the supervision of Principal Investigator and Research Scientist Dr. Raj Makkar and under the direction of a ClinicalResearch 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 ClinicalResearch Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
Evaluates and abstracts clinicalresearch data from source documents.
Ensures compliance with protocol and overall clinicalresearch objectives.
Completes Case Report Forms (CRFs).
Enters clinicalresearch 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.
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 clinicalresearch 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.
Req ID : 13060
Working Title : ClinicalResearchAssociate I - Heart Institute - Makkar Lab
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
$24-32.9 hourly 21h ago
Clinical Research Associate I - Regenerative Medicine Institute
Cedars-Sinai 4.8
Clinical research associate job at Cedars-Sinai
Join us as we translate today's discoveries, into tomorrow's medicine!
Regenerative medicine is a new and developing field that strives to restore function in diseased or aged tissues through either revitalizing existing cells or transplanting new ones. At the Board of Governors Regenerative Medicine Institute, researchers are turning stem cells into therapies for treating a multitude of prevalent diseases and conditions. We're also exploring how to prevent diseases, and we're extending our knowledge to students in Los Angeles and researchers around the world. To learn more, please visit Board of Governors Regenerative Medicine Institute | Cedars-Sinai
Are you ready to be a part of breakthrough research?
The ClinicalResearchAssociate I will work directly with a ClinicalResearch 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 clinicalresearch 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. Additionally, this position will include animal work (injections, dissections, and surgery), sample processing, and cell culture.
Primary Job Duties and Responsibilities:
Completes Case Report Forms (CRFs).
Enters clinicalresearch data into Electronic Data Systems (EDCs) that are provided by the sponsors.
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.
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.
Department-Specific Duties and Responsibilities:
Performs data searches and other related administrative tasks.
Assists with research protocol writing and development.
Transportation of research medications.
Performs study related assessments and questionnaires.
Assists with prescreening of potential research participants for various clinical trials.
Maintains organized paper and electronic research files.
Performs all data collection and data entry tasks for department clinical trials.
Assists with preparing manuscripts, letters, and other research documents as needed.
Responds to sponsor' inquiries regarding protocol start-up activities and recruitment.
Performs literature reviews.
Attends research meetings and monthly conference calls with sponsors for study updates.
Performs cell culture, immunohistochemistry including processing of samples.
Performs animal injections, dissections and surgery.
Assists with scheduling of visits and assessments.
Qualifications
Education:
High School Diploma or GED is required.
Experience and Skills:
ClinicalResearch related experience is preferred.
Ability to interpret and apply knowledge of State, Federal, and Agency standards to follow regulations.
Must possess digital literacy, including Word and Excel, and the ability to use standard office equipment is required.
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 : 12957
Working Title : ClinicalResearchAssociate I - Regenerative Medicine Institute
Department : Research - RMI
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
$24-32.9 hourly 21h ago
Clinical Research Coordinator II, Hybrid
Cedars-Sinai 4.8
Clinical research associate job at Cedars-Sinai
The ClinicalResearch Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Schedules patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
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.
May coordinate training and education of other personnel.
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
May plan and coordinate strategies for increasing patient enrollment, and/or improving clinicalresearch efficiency. Primary Duties and Responsibilities
May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
May identify new research opportunities and present to investigators
Participates in required training and education programs.
Department Unit
Verifies specimen identification, assesses appropriateness of test orders and quality of specimen by recognizing factors that affect procedures and results; takes appropriate action when corrections are indicated Identifies patients and patient samples by strict adherence to established procedures; labels samples accurately and completely. Reports test results to appropriate individuals and exercises professional discretion with patient information.
Neuroscience
Transportation of research medications.
Performs research study related assessments and questionnaires.
Assists with prescreening of potential research participants for various clinical trials
Attends research meetings and monthly conference calls with sponsors for study updates.
Maintains organized paper and electronic research files
Performs all data collection and data entry tasks for department clinical trials.
Assists with preparing manuscripts, letters, and other research documents as needed.
Responds to sponsor' inquiries regarding protocol start-up activities and recruitment.
Performs literature reviews
Hepatology Transplant Research
Assists with budget development and negotiation in partnership with CTAO and sponsors to ensure budgets are fully compliant with all CSMC policies.
May facilitate training and education of other personnel including mentorship for junior research staff to improve workflow efficiencies.
Qualifications
This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable are
Minimum Requirements
High School Diploma/GED.
2 years Clinicalresearch related experience.
Preferred:
Bachelor's Degree
Req ID : 13918
Working Title : ClinicalResearch Coordinator II, Hybrid
Department : Cancer - SOCCI ClinicalResearch
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $28.30 - $48.11
$28.3-48.1 hourly 21h ago
Surgery Chair Clinical Research Coordinator II
Cedars-Sinai 4.8
Clinical research associate job at Cedars-Sinai
Come join our team!
The ClinicalResearch Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties & Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Schedules patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
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.
May coordinate training and education of other personnel.
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
May plan and coordinate strategies for increasing patient enrollment, and/or improving clinicalresearch efficiency.
May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
May identify new research opportunities and present to investigators
Participates in required training and education programs.
Qualifications
Education, Experience, & Certification Requirements:
High School Diploma/GED required. Bachelor's Degree in Science, Sociology or related degree preferred.
Two (2) years of clinicalresearch related experience required.
SOCRA or ACRP certification preferred.
Req ID : 12196
Working Title : Surgery Chair ClinicalResearch Coordinator II
Department : Research - Surgery Chair
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $58,864 - $100,068
$58.9k-100.1k yearly 21h ago
Clinical Research Coordinator III - Cardiology Research - Makkar Lab
Cedars-Sinai 4.8
Clinical research associate job at Cedars-Sinai
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 ClinicalResearch Coordinator III works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for oversight of all studies with the group and the assignment of studies to clinicalresearch personnel within the group, and supervision of research staff. Plans and coordinates strategies for increasing patient enrollment, improving efficiency, training of personnel, and identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Job Duties and Responsibilities:
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Scheduling of patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May involve other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
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.
Works with Training and Education Coordinator to ensure all staff is properly trained and certified.
Participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
Plans and coordinates strategies for increasing patient enrollment, and/or improving clinicalresearch efficiency.
Identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
Identifies new research opportunities and presents to investigators.
Supervises other research staff.
Qualifications
Education:
High School Diploma/GED required.
Bachelor's degree in Science, Sociology, or a related field preferred.
License/Certification:
Certification in ClinicalResearch from ACRP/SOCRA is preferred.
Experience:
Four (4) years of clinicalresearch related experience is required.
Req ID : 13090
Working Title : ClinicalResearch Coordinator III - Cardiology Research - Makkar Lab
Department : Research - Cardiology
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $71,219.20 - $121,076.80
$71.2k-121.1k yearly 21h ago
Surgery Chair Clinical Research Coordinator II
Cedars-Sinai 4.8
Clinical research associate job at Cedars-Sinai
Come join our team!
The ClinicalResearch Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties & Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Schedules patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
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.
May coordinate training and education of other personnel.
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
May plan and coordinate strategies for increasing patient enrollment, and/or improving clinicalresearch efficiency.
May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
May identify new research opportunities and present to investigators
Participates in required training and education programs.
Qualifications
Education, Experience, & Certification Requirements:
High School Diploma/GED required. Bachelor's Degree in Science, Sociology or related degree preferred.
Two (2) years of clinicalresearch related experience required.
SOCRA or ACRP certification preferred.
Req ID : 12196
Working Title : Surgery Chair ClinicalResearch Coordinator II
Department : Research - Surgery Chair
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $58,864 - $100,068
$58.9k-100.1k yearly 21h ago
Surgery Chair Clinical Research Coordinator II
Cedars-Sinai 4.8
Clinical research associate job at Cedars-Sinai
Come join our team!
The ClinicalResearch Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties & Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Schedules patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
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.
May coordinate training and education of other personnel.
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
May plan and coordinate strategies for increasing patient enrollment, and/or improving clinicalresearch efficiency.
May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
May identify new research opportunities and present to investigators
Participates in required training and education programs.
Qualifications
Education, Experience, & Certification Requirements:
High School Diploma/GED required. Bachelor's Degree in Science, Sociology or related degree preferred.
Two (2) years of clinicalresearch related experience required.
SOCRA or ACRP certification preferred.
Req ID : 12196
Working Title : Surgery Chair ClinicalResearch Coordinator II
Department : Research - Surgery Chair
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $58,864 - $100,068
$58.9k-100.1k yearly 21h ago
Clinical Research Coordinator II - The Angeles Clinic & Research Institute
Cedars-Sinai 4.8
Clinical research associate job at Cedars-Sinai
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 our patients with cancer.
Join our team and contribute to groundbreaking research.
The ClinicalResearch Coordinator II serves as the lead coordinator on an assigned portfolio of research studies, functioning independently to establish and coordinate logistics and processes for the conduct of research for the department. This individual will interact with principal investigators, subjects, clinic and research staff, laboratory staff, medical professionals, pharmaceutical staff, and Sponsor representatives to successfully implement research protocols, in compliance with all applicable regulatory requirements.
Establishes and completes logistical aspects of clinicalresearch projects to achieve project objectives, including project planning, projecting resource requirements, and developing systems to ensure protocol compliance and patient safety.
Coordinates administrative functions of research studies, including scheduling of patients for research visits, procedures and labs and completion and maintenance of consent forms, case report forms, SAE's and source documents.
Responsible for screening and recruitment of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and supporting the informed consent process.
Responsible for accurate and timely data collection, documentation, entry and reporting, including resolution of queries from sponsors or regulatory entities.
Coordinates institutional, pharmaceutical and internal audits, including facilitating third party study monitoring and designs and implements needed corrective actions.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Responsible for timely submission of adverse events, serious adverse events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
Plans and coordinates strategies for growing research participant enrollment, and/or improving clinicalresearch efficiency as needed.
Provides technical support for the preparation of grant proposals, publications, presentations and special projects.
Provides assistance with research project budget development, including identifying and classifying routine care vs. research related care and provides assistance with research participant research billing and reconciliation.
Participate in meetings and conferences related to research activities, including research staff meetings.
Participate in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as vital or requested; Participates in training and education of new research personnel.
Perform accurate processing of research laboratory specimens while demonstrating an advanced degree of proficiency and understanding of research protocol and laboratory procedures, including centrifuging, aliquoting, storing, and shipping of specimens.
Monitor deliveries from sponsor, including inventory of kits, unpacking, and storing of supplies, and utilizing kits and supplies appropriately for specimen collection, processing, storage, and shipping, as mandated by sponsor. Maintain electronic record of supplies.
Participate in monitoring and auditing activities to ensure compliance, including proposal of solutions to technical issues and subsequent implementation of corrective actions.
Qualifications
Educational Requirements:
Associates Degree/College Diploma required
Bachelor's Degree preferred
Licenses/Certification:
Basic Life Support (BLS) from the American Heart Association required (BLS expiration date must be valid 60 days from the start date)
SoCRA or ACRP certification preferred
Experience:
3 years of clinicalresearch coordination or related experience.
#Jobs-Indeed
#LI
Req ID : 12709
Working Title : ClinicalResearch Coordinator II - The Angeles Clinic & Research Institute
Department : Angeles Research Inst
Business Entity : Cedars-Sinai Medical Care Foundation
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $31.46 - $48.76
$31.5-48.8 hourly 21h ago
Clinical Research Coordinator II - Guerin Children's - Developmental-Behavioral Pediatrics - Full-Time, On-Site, Days
Cedars-Sinai 4.8
Clinical research associate job at Cedars-Sinai
Grow your career at Cedars-Sinai!
Cedars-Sinai Medical Center has been named to the Honor Roll in U.S. News & World Report's “Best Hospitals 2024-2025” rankings. At Cedars-Sinai, we take pride in hiring the best, most hard-working employees. Our dedicated doctors, nurses and staff reflect the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a dynamic, inclusive environment that fuels innovation and the gold standard of patient care we strive for.
What will you be doing in this role?
The ClinicalResearch Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties & Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Schedules patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
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.
May coordinate training and education of other personnel.
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
May plan and coordinate strategies for increasing patient enrollment, and/or improving clinicalresearch efficiency.
May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
May identify new research opportunities and present to investigators
Participates in required training and education programs.
Qualifications
Education, Experience, & Certification Requirements:
High School Diploma/GED required. Bachelor's Degree in Science, Sociology or related degree preferred.
Two (2) years of clinicalresearch related experience required.
SOCRA or ACRP certification preferred.
Experience with gene therapy clinical trials and pediatric populations preferred.
Experience with clinical trial budgeting and regulatory for FDA-regulated therapeutics preferred.
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 : 13260
Working Title : ClinicalResearch Coordinator II - Guerin Children's - Developmental-Behavioral Pediatrics - Full-Time, On-Site, Days
Department : Research - Pediatrics
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $58,864.00 - $100,068.80
$58.9k-100.1k yearly 21h ago
Surgery Chair Clinical Research Coordinator II
Cedars-Sinai 4.8
Clinical research associate job at Cedars-Sinai
Come join our team!
The ClinicalResearch Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties & Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Schedules patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
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.
May coordinate training and education of other personnel.
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
May plan and coordinate strategies for increasing patient enrollment, and/or improving clinicalresearch efficiency.
May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
May identify new research opportunities and present to investigators
Participates in required training and education programs.
Qualifications
Education, Experience, & Certification Requirements:
High School Diploma/GED required. Bachelor's Degree in Science, Sociology or related degree preferred.
Two (2) years of clinicalresearch related experience required.
SOCRA or ACRP certification preferred.
Req ID : 12196
Working Title : Surgery Chair ClinicalResearch Coordinator II
Department : Research - Surgery Chair
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $58,864 - $100,068
$58.9k-100.1k yearly 21h ago
Clinical Research Coordinator I, Laboratory (Onsite) + CPT1 - The Angeles Clinic & Research Institute
Cedars-Sinai 4.8
Clinical research associate job at Cedars-Sinai
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 our patients with cancer.
Join our team and contribute to groundbreaking research.
This position functions as a ClinicalResearch Coordinator providing support for clinicalresearch protocols for the department. The ClinicalResearch Coordinator will assist the Research Department with all aspects of clinicalresearch. This individual will interact with principal investigators, subjects, clinic and research staff, laboratory staff, medical professionals, pharmaceutical staff, and Sponsor representatives to successfully implement research protocols, in compliance with all regulatory requirements.
Primary Duties & Responsibilities
Perform accurate processing of research laboratory specimens while demonstrating a moderate degree of proficiency and understanding of research protocol and laboratory procedures, including centrifuging, aliquoting, storing, and shipping of specimens.
Monitor deliveries from sponsor, including inventory of kits, unpacking, and storing of supplies, and using kits and supplies appropriately for specimen collection, processing, storage, and shipping, as mandated by sponsor. Maintain electronic record of supplies.
Responsible for administrative functions of research studies, including scheduling of patients for research visits, procedures and labs and completion and maintenance of consent forms, case report forms, SAE's and source documents.
Facilitates screening and recruitment of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and supporting the informed consent process.
Coordinates logistical aspects of clinicalresearch projects to achieve project objectives, including project planning, projecting resource requirements, and developing systems to ensure protocol compliance and patient safety.
Responsible for accurate and timely data collection, documentation, entry and reporting, including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities to ensure compliance, including implementing any corrective actions.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Works closely with investigators and regulatory staff or directly with Institutional Review Board (IRB) to submit adverse events, serious adverse events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
Acts as a liaison with pharmaceutical company representatives or other project funding organizations to monitor and update project progress.
Provides assistance with research finance billing, including identifying and classifying routine care vs. research related care.
Attends meetings and conferences related to research activities, including research staff meetings. Participates in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as necessary or requested.
Qualifications
Educational Requirements:
High School Diploma or GED required.
Associate degree/College Diploma preferred.
Licenses/Certification:
Certified Phlebotomy Technician I (CPT1) license from State of California required. (Please note your license number in your resume and application).
Basic Life Support (BLS) from the American Heart Association required. (BLS expiration date must be valid 60 days from the start date).
Experience:
6 months of healthcare related or research experience required.
Phlebotomy and lab assistant experience with demonstrated proficiency in the job duties listed above.
1 year of experience as a clinicalresearch coordinator or clinicalresearchassociate/assistant preferred.
**This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace. Please note that hybrid or remote work options are NOT available for this position at this time.
#Jobs-Indeed
#LI
#LI-Onsite
#LI-LA2
Req ID : 10430
Working Title : ClinicalResearch Coordinator I, Laboratory (Onsite) + CPT1 - The Angeles Clinic & Research Institute
Department : Angeles Research Inst
Business Entity : Cedars-Sinai Medical Care Foundation
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $27.18 - $42.13
$27.2-42.1 hourly 21h ago
Clinical Research Coordinator I - Guerin Children's - Pizzo Lab - Full-Time, On-Site, Days
Cedars-Sinai 4.8
Clinical research associate job at Cedars-Sinai
Grow your research career at Cedars-Sinai Guerin Children's! To learn more, please visit: Cedars-Sinai Guerin Children's.
The ClinicalResearch Coordinator I works independently providing study coordination, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents study information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities:
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Schedules patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
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
Educational, Certification, and Experience Requirements:
High School Diploma/GED required. Bachelor's Degree in Science, Sociology or related degree preferred.
SOCRA or ACRP Certification preferred upon hire
One (1) year of clinicalresearch related experience required.
Prior experience working with pediatric populations preferred.
Prior clinic or sample processing experience preferred.
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 : 12948
Working Title : ClinicalResearch Coordinator I - Guerin Children's - Pizzo Lab - Full-Time, On-Site, Days
Department : Research - Pediatrics
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 - $39.76