Clinical Research Scientist PhD - Sponsored Research
Clinical research coordinator job at ProMedica Toledo Hospital
Department: Sponsored Research Hours: 40 Shift: Days (United States of America) As the Clinical Research Scientist, you implement investigator-initiated clinical research studies through collaboration with physicians, researchers, and research staff.
You will develop hypotheses, research methodology, study design, statistical analysis, writing and publication of results.
The above summary is intended to describe the general nature and level of work performed by the positions. It should not be considered exhaustive.
ACCOUNTABILITIES
* All duties listed below are essential unless noted otherwise*
* Provides guidance to researchers in study design, research methodology and protocol preparation. Able to independently prepare and implement research protocols as principal investigator.
* Prepares draft manuscripts from study data. Performs independent literature searches, annotates selected papers, and organizes results in summary or database form.
* Leads and/ or participates in clinical research teams designed to grow investigator-initiated research by specialty.
* Able to complete submissions to the Institutional Review Board and maintain regulatory documentation, ensuring compliance with local policies and federal regulations.
* Ability to independently abstract data from medical record and/or quality registries and coordinate data abstraction with learners. Works with IT and Quality resources, as needed, to optimize data queries. Perform quality checks to ensure data integrity.
* Organizes study data in computerized format and performs data analysis.
* Perform prospective investigator-initiated research trials including identification and enrollment of study subjects.
* Directs work of student interns, IIR staff, medical students, and residents to ensure successful implementation of retrospective and prospective clinical trials.
* Identifies and applies for study funding, as appropriate. Oversees awards and sub-awards including contractual and budgetary obligations.
* Develops abstracts and manuscripts for presentation to local, regional, and national conferences.
* Participates in project teams and performs other duties as assigned.
REQUIRED QUALIFICATIONS
Education: PhD
Skills: Strong inter-personal skills both written and verbal.
Years of Experience: 5 years' experience in scientific research methodology and design and data analysis. Proven track record of manuscript preparation and publication.
PREFERRED QUALIFICATIONS
Education: PhD
Skills: Sponsored clinical trial experience desired and familiarity with clinical setting and medical terminology. Excellent computer skills including Epic EMR and excel preferred. Ability to perform statistical analyses, including sample size estimation, for study design and analysis of results. Must be able to successfully complete the hospital/unit professional orientation. Responsible for maintenance of competency. Ability to travel. Ability to engage effectively with all team members to build a team approach to problem solving. Effective oral and written communication skills, ability to work with patients, clinical and operations team.
Years of Experience: 5+ years
WORKING CONDITIONS
Personal Protective Equipment: As needed.
Physical Demands: Must be able to move about hospital and between workstations; and prolonged periods of standing. Must be able to understand directions, communicate and respond to inquiries; requires effective interpersonal skills. Must be able to tolerate exposure to dust, fumes, chemicals, temperature changes and exposure to blood borne pathogens and bodily fluids. Must be able to move, lift and carry light to heavy patients or equipment up to 50 lbs. Must be able to input and retrieve information from computer.
ProMedica is a mission-driven, not-for-profit health care organization headquartered in Toledo, Ohio. It serves communities across nine states and provides a range of services, including acute and ambulatory care, a dental plan, and academic business lines. ProMedica owns and operates 10 hospitals and has an affiliated interest in one additional hospital. The organization employs over 1,300 health care providers through ProMedica Physicians and has more than 2,300 physicians and advanced practice providers with privileges. Committed to its mission of improving health and well-being, ProMedica has received national recognition for its clinical excellence and its initiatives to address social determinants of health. For more information about ProMedica, please visit promedica.org/aboutus.
Benefits:
We provide flexible benefits that include compensation and programs to help you take care of your family, your finances and your personal well-being. It's what makes us one of the best places to work, and helps our employees live and work to their fullest potential.
Qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, religion, sex/gender (including pregnancy), sexual orientation, gender identity or gender expression, age, physical or mental disability, military or protected veteran status, citizenship, familial or marital status, genetics, or any other legally protected category. In compliance with the Americans with Disabilities Act Amendment Act (ADAAA), if you have a disability and would like to request an accommodation in order to apply for a job with ProMedica, please contact ************************
Equal Opportunity Employer/Drug-Free Workplace
Clinical Research Finance Coordinator II (Pre-Award): Remote Role
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 Clinical Research Finance Coordinator II (Pre-Award) to join our dynamic research team. In this role, you will be responsible for the financial management of clinical research 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 Clinical Research Budget Coordinator II develops complex clinical trial budgets for industry, National Institutes of Health (NIH), and investigator-initiated clinical research. Evaluates research protocols to assess resource needs, procedures, clinical research 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, clinical research 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 clinical research. 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 Clinical Research Finance Coordinator II (Pre-Award) position, applicants must have direct experience in a clinical research 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 clinical research 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 clinical research.
Req ID : 6747
Working Title : Clinical Research Finance Coordinator II (Pre-Award): Remote Role
Department : Cancer - SOCCI Clinical Research
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
Clinical Research Coordinator I - Department of Neurology (Hybrid)
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. Ranked among the best in the nation by U.S. News & World Report, our neurosurgeons and neurologists work together with experienced care teams to give patients the most effective treatment possible.
About the Role
This position will support the research programs in Department of Anesthesia and Neurology.
The Clinical Research Coordinator I will work independently providing study coordination including screening of research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. The CRC I member is responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. This role is responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. The incumbent presents study information at research staff meeting. This position ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board.
Primary Duties and Responsibilities:
Scheduling of research participants for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) information about changes in research participant condition, adverse events, concomitant medication use, protocol compliance, and response to study drug.
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 following 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.
Participates in required training and education programs.
Coordinates training and education of other personnel.
Department-Specific Duties and Responsibilities:
Transportation of research medications.
Performs research study related assessments and questionnaires.
Assists with prescreening of 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.
Qualifications
Education:
High School Diploma/GED, required.
Bachelor's degree in a Science, Sociology, or related field is preferred.
Licenses/Certifications:
ACRP/SOCRA certification is preferred.
Experience:
1 year of clinical research 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 : 10438
Working Title : Clinical Research Coordinator I - Department of Neurology (Hybrid)
Department : Research - Neurology
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 : $23.39 - $39.76
Clinical Research Coordinator II, Thoracic (Hybrid)
Beverly Hills, CA jobs
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 area.
The Clinical Research Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Schedules patients for research visits and procedures. In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct. Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
May coordinate training and education of other personnel.
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research 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
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 area.
Requirements:
High School Diploma/GED required. Bachelor's Degree Science, Sociology or related degree preferred.
2 years Clinical research related experience required.
Req ID : 11820
Working Title : Clinical Research Coordinator II, Thoracic (Hybrid)
Department : Cancer - SOCCI Clinical Research
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
Clinical Research Coordinator II, Hybrid
Beverly Hills, CA jobs
The Clinical Research Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Schedules patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
May coordinate training and education of other personnel.
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research 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 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.
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 Clinical research related experience.
Preferred:
Bachelor's Degree
Req ID : 13918
Working Title : Clinical Research Coordinator II, Hybrid
Department : Cancer - SOCCI Clinical Research
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
Clinical Research Associate I - Urology
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. With a team focused on effective pain management and quick recovery, Cedars-Sinai has been ranked as the No. 1 hospital in Southern California for Orthopaedics by U.S. News & World Report. Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements!
The Clinical Research Associate I (CRAI) will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. The CRAI evaluates and abstracts research data and ensures compliance with protocol and research objectives. This role is responsible for completing case report forms (CRFs) and entering clinical research data, as well as providing limited contact with research participants as needed for study and assists with study/long term follow-up research participants only.
Primary Duties & Responsibilities:
• Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
• Evaluates and abstracts clinical research data from source documents.
• Ensures compliance with protocol and overall clinical research objectives.
• Completes Case Report Forms (CRFs).
• Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
• Provides supervised patient contact or patient contact for long term follow-up patients only.
• Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
• Assists with clinical trial budgets.
• Assists with patient research billing.
• Schedules patients for research visits and research procedures.
• Responsible for sample preparation and shipping and maintenance of study supplies and kits.
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Participates in required training and education programs
Qualifications
Educational Requirements:
High School Diploma/GED
Bachelors degree in science or related degree preferred
Experience:
1-year clinical research related experience preferred
Physical Demands:
Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.
Understanding of general clinical research objectives. Clinical research experience, preferred
Req ID : 13483
Working Title : Clinical Research Associate I - Urology
Department : Urology
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 : $19.50 - $32.86
Clinical Research Associate I - CA Heart Foundation
Beverly Hills, CA jobs
Grow your career at Cedars-Sinai!
The California Heart Center is an affiliate of the Cedars-Sinai Heart Institute, located in Beverly Hills, California, 90211. We offer the full spectrum of cardiology care, including, Cardiac Evaluation/Adult Cardiology, Heart Failure Management, Interventional Cardiology, Nuclear Cardiology and Echocardiography.
In addition to our private cardiology practice, CA Heart Center physicians are active clinical research investigators and hold leadership positions in heart failure, heart transplantation, and mechanical cardiac assist devices and heart failure/transplant clinical research at the Cedars-Sinai Heart Institute (CSHI). In addition to its highly-regarded cardiology program, CSHI is doing groundbreaking work in other important cardiovascular areas, including cardiac stem cell transplants and non-surgical heart valve replacements. In partnership with CSHI, the California Heart Center offers a multi-disciplinary and integrated approach to the care of patients with heart disease.
Why work here?
Beyond an outstanding benefits package and competitive salaries, we take pride in hiring the best, most committed employees. Our staff reflects the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a multifaceted, inclusive environment that fuels innovation and the gold standard of care we strive for.
Are you ready to be a part of breakthrough research?
The Clinical Research Associate I works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports research objectives through tasks like data collection, candidate evaluation, participant scheduling, IRB assistance, budget management, and regulatory compliance.
Primary Duties & Responsibilities:
Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
Evaluates and abstracts clinical research data from source documents.
Ensures compliance with protocol and overall clinical research objectives.
Completes Case Report Forms (CRFs).
Enters clinical research data into Electronic Data Systems (EDCs) that the sponsors provide.
Provides supervised patient contact or patient contact for long term follow-up patients only.
Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Assists with clinical trial budgets.
Assists with patient research billing.
Assists with prescreening of potential research participants for various clinical trials.
Schedules patients for research visits and research procedures.
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Qualifications
Education:
High School Diploma/GED is required. Bachelor's degree in Science, Sociology, or a related field preferred.
Experience and Skills:
No experience required. One (1) year of clinical research related experience is preferred.
Ability to interpret and apply knowledge of State, Federal, and Agency standards to align with regulations.
Ability to convey and/or receive written/verbal information to/from various audiences in different formats.
Req ID : 13782
Working Title : Clinical Research Associate I - CA Heart Foundation
Department : CA Heart Foundation
Business Entity : Cedars-Sinai Medical Care Foundation
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $21.29 - $33.00
Surgery Chair Clinical Research Coordinator II
Modesto, CA jobs
Come join our team!
The Clinical Research Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties & Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Schedules patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
May coordinate training and education of other personnel.
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research 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 clinical research related experience required.
SOCRA or ACRP certification preferred.
Req ID : 12196
Working Title : Surgery Chair Clinical Research Coordinator II
Department : Research - Surgery Chair
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $58,864 - $100,068
Clinical Research Coordinator I - Emergency Dept Research - Full-Time, On-Site, Days
Fresno, CA jobs
Grow your career at Cedars-Sinai!
The Clinical Research Coordinator I works independently providing study coordination, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents study information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities:
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Schedules patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Qualifications
Educational, Certification, and Experience Requirements:
High School Diploma/GED required. Bachelor's Degree in Science, Sociology or related degree preferred.
SOCRA or ACRP Certification preferred upon hire
One (1) year of clinical research 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 : 12453
Working Title : Clinical Research Coordinator I - Emergency Dept Research - Full-Time, On-Site, Days
Department : Research - ED
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 : $23.39 - $39.76
Clinical Research Associate II - Women's Research Program - Full-Time, On-Site
Los Angeles, CA jobs
Come join our team!
The Clinical Research Associate II works independently but in close collaboration with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, other supervising staff to coordinate and/or implement increasingly complex 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. Provides increasingly complex and independent support for studies by serving as the independent contact with sponsors, IRB, and research participants, providing training, education to junior level staff, and coordination of ad hoc activities related to studies. May serve independently as study coordinator for minimal number of noncomplex research studies or projects.
What are the Primary Duties & Responsibilities?
Works independently under minimal direction from a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to coordinate and/or implement increasingly complex research studies.
Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Completes Case Report Forms (CRFs).
Independently prescreens potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. May provide increasingly independent contact with research participants and/or conduct research participant visits independently.
Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB). May work directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, Safety Letters, etc in accordance with local and federal guidelines.
Assists with clinical trial budgets and patient billing.
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
Ensures compliance with protocol and overall clinical research objectives. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local IRB. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
May serve as the primary point of contact for external sponsors for select trials. Responds to sponsor inquiries and attends meetings regarding study activities.
Participates in and provides training and education to other Clinical Research Associates. May assist in coordinating activities of other associates to ensure compliance with protocol and clinical research objectives.
Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications
May provide coordination of minimal number of noncomplex research studies or projects independently. May provide coverage for study coordination activities of supervising staff when needed to ensure minimal disruption to study objectives.
Qualifications
Education, Experience & License/Certification Requirements:
High School Diploma/GED required. Bachelor's Degree in Science, Sociology or related degree preferred.
One (1) year of clinical research related experience required
Certification in Clinical Research (SOCRA or ACRP) 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 : 13839
Working Title : Clinical Research Associate II - 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 : $21.26 - $36.14
Surgery Chair Clinical Research Coordinator II
Fresno, CA jobs
Come join our team!
The Clinical Research Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties & Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Schedules patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
May coordinate training and education of other personnel.
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research 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 clinical research related experience required.
SOCRA or ACRP certification preferred.
Req ID : 12196
Working Title : Surgery Chair Clinical Research Coordinator II
Department : Research - Surgery Chair
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $58,864 - $100,068
Clinical Research Coordinator II - Research Institute
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 Clinical Research Coordinator 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.
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 clinical research 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 : Clinical Research Coordinator 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
Clinical Research Coordinator II - Guerin Children's - Developmental-Behavioral Pediatrics - Full-Time, On-Site, Days
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 Clinical Research Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties & Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Schedules patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
May coordinate training and education of other personnel.
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research 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 clinical research 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 : Clinical Research Coordinator II - Guerin Children's - Developmental-Behavioral Pediatrics - Full-Time, On-Site, Days
Department : Research - Pediatrics
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $58,864.00 - $100,068.80
Clinical Research Coordinator I - Emergency Dept Research - Full-Time, On-Site, Days
Modesto, CA jobs
Grow your career at Cedars-Sinai!
The Clinical Research Coordinator I works independently providing study coordination, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents study information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities:
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Schedules patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Qualifications
Educational, Certification, and Experience Requirements:
High School Diploma/GED required. Bachelor's Degree in Science, Sociology or related degree preferred.
SOCRA or ACRP Certification preferred upon hire
One (1) year of clinical research 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 : 12453
Working Title : Clinical Research Coordinator I - Emergency Dept Research - Full-Time, On-Site, Days
Department : Research - ED
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 : $23.39 - $39.76
Clinical Research Coordinator I, Laboratory (Onsite) + CPT - The Angeles Clinic & Research Institute
Los Angeles, CA jobs
**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.
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 Clinical Research Coordinator providing support for clinical research protocols for the department. The Clinical Research Coordinator will assist the Research Department with all aspects of clinical research. 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 clinical research 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
Job qualifications:
High School Diploma or GED required.
6 months of Healthcare related or research experience.
Phlebotomy and lab assistant experience with demonstrated proficiency in the job duties listed above
Phlebotomy Certification from State of California, please note your license number in your resume.
Basic Life Support (BLS) from the American Heart Association required (BLS expiration date must be valid 60 days from the start date)
**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.
Preferred Job Requirements:
Associate Degree/College Diploma preferred.
1 year of experience as a clinical research coordinator or clinical research associate/assistant preferred.
Demonstrated ability to accurately process research laboratory specimens in accordance with study protocols and standard laboratory procedures. This includes centrifugation, aliquoting, proper storage, and shipment of specimens.
proficiency in understanding and adhering to research protocols and laboratory safety guidelines.
Experience monitoring and receiving study-related deliveries from sponsors, including performing inventory checks, unpacking, and storing of kits and supplies.
Ability to properly use sponsor-provided kits and supplies for specimen collection, processing, storage, and shipping as outlined in protocol requirements.
Proficient in maintaining electronic records of inventory and supplies to ensure adequate stock and traceability.
Req ID : 10430
Working Title : Clinical Research Coordinator I, Laboratory (Onsite) + CPT - 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
Clinical Research Coordinator I - Emergency Dept Research - Full-Time, On-Site, Days
Sacramento, CA jobs
Grow your career at Cedars-Sinai!
The Clinical Research Coordinator I works independently providing study coordination, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents study information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities:
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Schedules patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Qualifications
Educational, Certification, and Experience Requirements:
High School Diploma/GED required. Bachelor's Degree in Science, Sociology or related degree preferred.
SOCRA or ACRP Certification preferred upon hire
One (1) year of clinical research 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 : 12453
Working Title : Clinical Research Coordinator I - Emergency Dept Research - Full-Time, On-Site, Days
Department : Research - ED
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 : $23.39 - $39.76
Surgery Chair Clinical Research Coordinator II
Los Angeles, CA jobs
Come join our team!
The Clinical Research Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties & Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Schedules patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
May coordinate training and education of other personnel.
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research 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 clinical research related experience required.
SOCRA or ACRP certification preferred.
Req ID : 12196
Working Title : Surgery Chair Clinical Research Coordinator II
Department : Research - Surgery Chair
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $58,864 - $100,068
Surgery Chair Clinical Research Coordinator II
San Diego, CA jobs
Come join our team!
The Clinical Research Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties & Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Schedules patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
May coordinate training and education of other personnel.
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research 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 clinical research related experience required.
SOCRA or ACRP certification preferred.
Req ID : 12196
Working Title : Surgery Chair Clinical Research Coordinator II
Department : Research - Surgery Chair
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $58,864 - $100,068
Clinical Coordinator: 6 Medical
Akron, OH jobs
6 Medical
Full Time 36 hours/week
Nights 7p-730a
Onsite
Assists manager in the daily operations at the unit level, in collaboration with interdisciplinary teams. Assesses, plans, implements, and evaluated delivery of patient care on assigned unit and shift. Contributes to development and evaluations of assigned nursing personnel. Assists and provides nursing care utilizing specialized knowledge, judgement and skill.
Responsibilities:
1. Provides leadership and direction regarding unit goals and work environment by assisting nurse manager in his/her duties.
2. Demonstrates personal and professional accountability for self and staff.
3. Maintains unit safety for staff and patients.
4. Participates in performance improvement.
5. Participates in and supports staff recruitment and retention efforts.
6. Uses critical thinking to provide patient care management through staffing plan development, managing daily shift staffing, and delegation of resources.
7. Supports and assists within human resource management, including but not limited to coaching, time keeping, development and evaluation of nursing personnel.
8. Supports patient care and staffing needs throughout the Akron Children's Hospital enterprise.
9. Promotes a positive work environment and staff engagement.
10. Serves as a clinical resource to the interdisciplinary team.
11. Demonstrates the knowledge and skills necessary to provide care for the physical, psychological, social, educational and safety needs of the patients served.
12. Other duties as required.
Other information:
Technical Expertise
1. Proficiency in MS Office [Outlook, Excel, Word] or similar software is required.
2. Valid Ohio license.
3. Current Health Care Provider BLS training from the American Heart Association is required.
4. See the Department of Nursing Resuscitation Requirements and training policy #2102 for specific department requirements.
5. Relevant professional nursing certification, preferred.
Education and Experience
1. Education: Graduate from an accredited School of Nursing, BSN required, or current enrollment in a BSN program with program completion required within 2 years of assuming position.
2. Certification: May differ based on department/unit
3. Years of experience: Minimum two years relevant clinical experience with demonstrated management and leadership abilities is required.
4. Years of experience supervising: Previous charge nurse or other leadership experience is required.
5. Strong leadership skills including communication/organizational skills, time management, coping skills, motivation, problem solving, autonomy, and supporting teams is required.
Full Time
FTE: 0.900000
Status: Onsite
Clinical Coordinator: Behavioral Health Unit
Akron, OH jobs
Behavioral Health Unit
Full Time 36 Hours/week
Nights 7p-730a
every other weekend and holiday
Onsite
Assists manager in the daily operations at the unit level, in collaboration with interdisciplinary teams. Assesses, plans, implements, and evaluated delivery of patient care on assigned unit and shift. Contributes to development and evaluations of assigned nursing personnel. Assists and provides nursing care utilizing specialized knowledge, judgement and skill.
Responsibilities:
1. Provides leadership and direction regarding unit goals and work environment by assisting nurse manager in his/her duties.
2. Demonstrates personal and professional accountability for self and staff.
3. Maintains unit safety for staff and patients.
4. Participates in performance improvement.
5. Participates in and supports staff recruitment and retention efforts.
6. Uses critical thinking to provide patient care management through staffing plan development, managing daily shift staffing, and delegation of resources.
7. Supports and assists within human resource management, including but not limited to coaching, time keeping, development and evaluation of nursing personnel.
8. Supports patient care and staffing needs throughout the Akron Children's Hospital enterprise.
9. Promotes a positive work environment and staff engagement.
10. Serves as a clinical resource to the interdisciplinary team.
11. Demonstrates the knowledge and skills necessary to provide care for the physical, psychological, social, educational and safety needs of the patients served.
12. Other duties as required.
Other information:
Technical Expertise
1. Proficiency in MS Office [Outlook, Excel, Word] or similar software is required.
2. Valid Ohio license.
3. Current Health Care Provider BLS training from the American Heart Association is required.
4. See the Department of Nursing Resuscitation Requirements and training policy #2102 for specific department requirements.
5. Relevant professional nursing certification, preferred.
Education and Experience
1. Education: Graduate from an accredited School of Nursing, BSN required, or current enrollment in a BSN program with program completion required within 2 years of assuming position.
2. Certification: May differ based on department/unit
3. Years of experience: Minimum two years relevant clinical experience with demonstrated management and leadership abilities is required.
4. Years of experience supervising: Previous charge nurse or other leadership experience is required.
5. Strong leadership skills including communication/organizational skills, time management, coping skills, motivation, problem solving, autonomy, and supporting teams is required.
Full Time
FTE: 0.900000
Status: Onsite