Clinical Research Coordinator jobs at UCI Health - 276 jobs
Senior Clinical Research Coordinator
UCI Health 4.4
Clinical research coordinator job at UCI Health
Who We Are Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 public universities by U. S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot.
Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs.
It's located in one of the world's safest and most economically vibrant communities and is Orange County's second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.
To learn more about UC Irvine, visit www.
uci.
edu.
The Alpha Clinic (AC) provides a centralized infrastructure from which to work with UCI faculty and staff to enhance cell and gene therapy clinical trials and activities at UCI.
The UCI Alpha Clinic: • Is part of the California Institute for Regenerative Medicine (CIRM) Alpha Clinic network • Promotes and facilitates scientific collaborations and interactions • Provides centralized clinicalresearch infrastructure support for cell and gene therapy clinical trials • Accelerates the implementation of cell and gene therapy clinical trials at UCI Your Role on the Team Under the direction of the Assistant Director of ClinicalResearch Operations, the Senior ClinicalResearchCoordinator will be responsible for supporting clinicalresearch efforts of the UCI Alpha Clinic (AC) by providing comprehensive coordination and data management of sponsored clinical trials according to Good Clinical Practices (GCP), internal standard operating procedure (SOPs), and University policies and procedures.
The incumbent is responsible for supporting and coordinating all aspects of UCI AC trials and studies for protocol specific requirements, research procedures, research chart preparation, data collection, subject study management and record keeping.
Attends clinic to assist the Principal Investigator (PI) with recruitment, screening, consenting, administering questionnaires, etc.
Incumbent will ensure study protocols are followed, appropriate documentation is kept, and accurate data is collected.
Incumbent will be responsible for the preparation and submission of study documents to the Institutional Review Board (IRB), Sponsored Projects Administration (SPA) and other regulatory committees.
What It Takes to be Successful Required: Demonstrated high-level communication skills to convey information in a clear and concise way,synthesizing information and presenting it to others.
Demonstrated problem solving capabilities to resolve concerns that arise unexpectedly.
Demonstrated ability to research, properly evaluate information, and prepare concise, well organized reports, summaries, and correspondence.
Demonstrated ability to organize and prioritize a complex and dynamic workload.
Ability to multitask and meet deadlines, despite interruptions.
Ability to independently exercise discretion and sound judgment.
Ability to work collegially and cooperatively in a small office and to establish and maintain cooperative working relationships.
Demonstrated skill in interacting with persons of various social, cultural, economic and educational backgrounds.
Ability to prioritize assignments and achieve high productivity/quality with short time frames, under rigid deadlines, and /or in environments with frequent workload changes and competing demands.
Skill in working independently, taking initiative and following through on assignments.
Ability to think critically, compile data from various sources, analyze data, and prepare reports.
High level of integrity and honesty in maintaining confidentiality.
Foster and promote a positive attitude and professional appearance.
Strong attention to detail.
Working knowledge of computer software including Microsoft Office (Outlook, Word, Excel, and PowerPoint).
Experience with a nationally-recognized clinicalresearchcoordinator certification Bachelor's degree in related area and / or equivalent experience / training.
3-5 years Preferred: Advanced degree (MA, MS, or MPH) preferred Certification by the Society of ClinicalResearch Associates or the Association of ClinicalResearch Professionals.
Special Conditions: Flexible working hours required, may need to extend work hours into evenings and weekends on occasion Total Compensation In addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding.
These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks.
Please utilize the links listed here to learn more about our compensation practices and benefits.
Conditions of Employment: The University of California, Irvine (UCI) seeks to provide a safe and healthy environment for the entire UCI community.
As part of this commitment, all applicants who accept an offer of employment must comply with the following conditions of employment: Background Check and Live Scan Employment Misconduct* Legal Right to work in the United States Vaccination Policies Smoking and Tobacco Policy Drug Free Environment *Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.
The following additional conditions may apply, some of which are dependent upon business unit or job specific requirements.
California Child Abuse and Neglect Reporting Act E-Verify Pre-Placement Health Evaluation Details of each policy may be reviewed by visiting the following page - ***********
uci.
edu/new-hire/conditions-of-employment.
php Closing Statement: The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.
For the University of California's Affirmative Action Policy please visit: ***************
ucop.
edu/doc/4010393/PPSM-20.
For the University of California's Anti-Discrimination Policy, please visit: ***************
ucop.
edu/doc/1001004/Anti-Discrimination.
We are committed to attracting and retaining a diverse workforce along with honoring unique experiences, perspectives, and identities.
Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming.
UCI provides reasonable accommodations for applicants with disabilities upon request.
For more information, please contact Human Resources at ************** or eec@uci.
edu.
Consideration for Work Authorization Sponsorship Must be able to provide proof of work authorization
$57k-85k yearly est. 60d+ ago
Looking for a job?
Let Zippia find it for you.
Clinical Research Finance Coordinator III - Post Award
Cedars-Sinai 4.8
Los Angeles, CA jobs
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 1d ago
Clinical Research Finance Coordinator III - Post Award
Cedars-Sinai 4.8
Sacramento, CA jobs
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 1d ago
Clinical Research Coordinator II, Hybrid
Cedars-Sinai 4.8
Beverly Hills, CA jobs
The ClinicalResearchCoordinator 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 : ClinicalResearchCoordinator 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 1d ago
Clinical Research Finance Coordinator III - Post Award
Cedars-Sinai 4.8
Fresno, CA jobs
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 1d ago
Clinical Research Finance Coordinator II (Pre-Award): Remote Role
Cedars-Sinai 4.8
Beverly Hills, CA jobs
Please note: Only candidates residing in the following states will be considered for remote work: California, Arizona, Nevada, Oregon, Texas, Colorado, Minnesota, Florida, and Georgia.
Cedars-Sinai is seeking a ClinicalResearch Finance Coordinator II (Pre-Award) to join our dynamic research team. In this role, you will be responsible for the financial management of clinicalresearch studies during the pre-award phase. You will collaborate with principal investigators and study teams to develop and negotiate budgets, review contracts, and ensure compliance with institutional and sponsor regulations. This position requires strong attention to detail and expertise in research finance to support the successful launch of clinical studies.
The ClinicalResearch Budget Coordinator II develops 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 accounts and invoicing. 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 complex research protocols to assess resource needs, research procedures, clinicalresearch staff time, investigator time, and costs from ancillary departments.
Determines whether research procedures in the protocol are standard-of-care or a research-related costs in order to correctly classify expenses.
Develops complex clinical trial budgets for industry and the National Institutes of Health (NIH) as well as investigator-initiated clinicalresearch. Works with the CSMC office of Sponsored Research to develop final budgets for clinical trials and research projects.
Negotiates trial budgets and payment terms with industry sponsors.
Monitors study accounts to evaluate the cost expenses/details are appropriate and within expected limits, reconciles accounts receivable and payments, and recommends the best course of action for any deficits and/or surpluses. Negotiates with sponsors the final payment due for account closeout. May conduct review and/or audits of clinical trial budgets. Serves as a resource 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 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 to influence business results. Prepares and delivers data, reports and/or presentations to investigators, management and/or leadership.
Enters financial information from finalized clinical trials budgets and clinical trial agreements into the Clinical Trial Management System. Reviews and finalizes clinical trials calendars to ensure agreement with Medicare coverage analysis and clinical trial 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. Process budget/contract amendments as applicable.
May provide training and education to other personnel.
May plan and coordinate strategies to improve existing standard operating procedures related to budgeting and clinical trials finance. May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
Qualifications
To be considered for the ClinicalResearch Finance Coordinator II (Pre-Award) position, applicants must have direct experience in a clinicalresearch setting. This role requires a understanding of the financial aspects of clinical trials, including budget preparation, funding management, and financial reporting, all within the context of research projects. Applicants should have hands-on experience in pre-award processes, such as the preparation of grant proposals, contract negotiations, and coordination with internal and external stakeholders to ensure compliance with funding requirements. Prior experience working within a clinicalresearch environment is essential to effectively manage the complexities of this role.
High School Diploma or equivalent experience/GED required. Bachelor's Degree Accounting, Finance, or other related degree preferred.
Minimum of 3 years of experience with billing, accounting, finance, budgeting, financial analysis or related field.
Minimum of 1 year of experience in clinicalresearch.
Req ID : 6747
Working Title : ClinicalResearch Finance Coordinator II (Pre-Award): Remote Role
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 : $34.24 - $58.21
$34.2-58.2 hourly 1d ago
Clinical Research Coordinator III - Cardiology Research - Makkar Lab
Cedars-Sinai 4.8
Los Angeles, CA jobs
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 ClinicalResearchCoordinator 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 : ClinicalResearchCoordinator 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 1d ago
Clinical Research Associate I - Women's Research Program - Full-Time, On-Site
Cedars-Sinai 4.8
Los Angeles, CA jobs
Come join our team!
The ClinicalResearch Associate I works under the direction of a ClinicalResearchCoordinator, 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 ClinicalResearchCoordinator, 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 : ClinicalResearch Associate 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 1d ago
Surgery Chair Clinical Research Coordinator II
Cedars-Sinai 4.8
Modesto, CA jobs
Come join our team!
The ClinicalResearchCoordinator 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 ClinicalResearchCoordinator 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 1d ago
Surgery Chair Clinical Research Coordinator II
Cedars-Sinai 4.8
Sacramento, CA jobs
Come join our team!
The ClinicalResearchCoordinator 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 ClinicalResearchCoordinator 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 1d ago
Surgery Chair Clinical Research Coordinator II
Cedars-Sinai 4.8
Fresno, CA jobs
Come join our team!
The ClinicalResearchCoordinator 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 ClinicalResearchCoordinator 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 1d ago
Clinical Research Associate I - Medically Associated Science & Technology (MAST) Program
Cedars-Sinai 4.8
Los Angeles, CA jobs
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 ClinicalResearch Associate I, you will work under the direction of a ClinicalResearchCoordinator, 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 : ClinicalResearch Associate 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 1d ago
Clinical Research Associate I - Yang Lab - Karsh Division of Gastroenterology and Hepatology
Cedars-Sinai 4.8
Beverly Hills, CA jobs
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 ClinicalResearch Associate 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 ClinicalResearch Associate I, you will work directly with a ClinicalResearchCoordinator, 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 : ClinicalResearch Associate 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 1d ago
Clinical Research Coordinator II - The Angeles Clinic & Research Institute
Cedars-Sinai 4.8
Los Angeles, CA jobs
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 ClinicalResearchCoordinator 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 clinicalresearchcoordination or related experience.
#Jobs-Indeed
#LI
Req ID : 12709
Working Title : ClinicalResearchCoordinator 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 1d ago
Clinical Research Coordinator II - Guerin Children's - Developmental-Behavioral Pediatrics - Full-Time, On-Site, Days
Cedars-Sinai 4.8
Los Angeles, CA jobs
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 ClinicalResearchCoordinator 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 : ClinicalResearchCoordinator 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 1d ago
Surgery Chair Clinical Research Coordinator II
Cedars-Sinai 4.8
Los Angeles, CA jobs
Come join our team!
The ClinicalResearchCoordinator 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 ClinicalResearchCoordinator 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 1d ago
Clinical Research Coordinator I, Laboratory (Onsite) + CPT1 - The Angeles Clinic & Research Institute
Cedars-Sinai 4.8
Los Angeles, CA jobs
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 ClinicalResearchCoordinator providing support for clinicalresearch protocols for the department. The ClinicalResearchCoordinator 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 clinicalresearchcoordinator or clinicalresearch associate/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 : ClinicalResearchCoordinator 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 1d ago
Clinical Research Coordinator II - Pulmonary Research Program/Lung Institute
Cedars-Sinai 4.8
Los Angeles, CA jobs
Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements!
Work alongside physician-scientists and researchers who are making life-saving medical and scientific breakthroughs. Our team of scientists develop some of the most advanced clinical trials in the world.
As a ClinicalResearchCoordinator II, you will work 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. The incumbent will be responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. The CRC II member will be responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. The incumbent will present information at research staff meetings, may plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. This position 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:
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.
Schedules and participates in monitoring and auditing activities.
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.
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 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:
High School Diploma/GED, required.
Bachelor's degree, preferred.
Licenses/Certifications:
ACRP/SOCRA (or equivalent) certification, preferred.
Experience:
2 years of clinicalresearch related experience, 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 : 14418
Working Title : ClinicalResearchCoordinator II - Pulmonary Research Program/Lung Institute
Department : Research - Pulmonary
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 1d ago
Clinical Research Coordinator II - Research Institute
Cedars-Sinai 4.8
Los Angeles, CA jobs
Grow your career at Cedars Sinai!
Cedars Sinai offers a culture of happiness, passion, and dedication. This is one of the many reasons why we rank as one of the top hospitals in California and in the nation by U.S. News & World Report.
Do you have a passion for helping human kind?
The Clinical and Translational Science Institute (CTSI) aligns its strengths to support clinical and translational science that fully partners with-and responds to-the needs of our Los Angeles community. The CTSI bridges disciplinary and institutional boundaries to create transdisciplinary teams focused on the greatest opportunities and the greatest needs in our region.
The ClinicalResearchCoordinator II works independently providing study coordination including screening of 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 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:
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.
Schedules and participates in monitoring and auditing activities.
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.
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 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.
#LI-Onsite
Qualifications
Education:
High School Diploma/GED, required.
Bachelor's degree in Science, Sociology, or related field is preferred.
Licenses/Certifications:
ACRP/SoCRA certification is preferred.
Experience:
2 years of clinicalresearch experience, 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 : 13369
Working Title : ClinicalResearchCoordinator II - Research Institute
Department : Research Institute
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 1d ago
Clinical Research Coordinator I - Guerin Children's - Pizzo Lab - Full-Time, On-Site, Days
Cedars-Sinai 4.8
Los Angeles, CA jobs
Grow your research career at Cedars-Sinai Guerin Children's! To learn more, please visit: Cedars-Sinai Guerin Children's.
The ClinicalResearchCoordinator 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 : ClinicalResearchCoordinator 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