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Clinical Research Manager jobs at Baylor Scott & White Health

- 1871 jobs
  • Clinical Genomic Scientist- Clinical Indication

    Baylor Genetics 4.5company rating

    Clinical research manager job at Baylor Scott & White Health

    Baylor Genetics, one of the world leaders in clinical molecular genetics, is excited to announce an opening in the Clinical Genomics Interpretation (CGI) division. This role requires a comprehensive understanding of clinical genetics, familiarity with reviewing clinical notes, and ability to interpret a pedigree. As part of the WGS Clinical Indication Team, the “Clinical Genomic Scientist” reviews clinical notes and converts patient phenotypes into Human Phenotype Ontology (HPO) terminology, records prior genetic testing history, interprets family history from pedigrees, and confirms consent answers from test requisition forms. The Clinical Genomic Scientist position is a remote work opportunity, with daily huddles, clear objectives, and flexible scheduling. Come join our team from the comfort of your home office! Duties and Responsibilities on the WGS Clinical Indication Team: 80 to 100%: Reviewing test requisition forms and clinical notes, extracting clinical information into structured data, such as HPO terms Up to 20%: As needed, opportunities for cross-training in WGS variant curations or WGS report writing may become available Qualifications Degree: Master's in Genetic Counseling, MD/PhD with a background in clinical genetics Preferred: Master's in Genetic Counseling Experience: Expertise in concepts of clinical medicine, genetics, genomics, and molecular biology. Experience in communicating genetic details effectively. Excellence in reading/writing medical language. Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook). Desired: Experience in genetic counseling, familiarity reviewing clinical notes and medical writing. Desired: Familiarity with American College of Medical Genetics (ACMG) variant curation guidelines. Desired: Knowledge of genomic variation and its correlation with human disease. Rank: Clinical Genomic Scientist - Clinical Indication I Degree: Masters in Genetic Counseling, MD, or PhD in clinical medicine, genetics, molecular biology, or equivalent. 0-1 years of experience with Human Phenotype Ontology (HPO)-related work and/or clinical experience. Rank: Clinical Genomic Scientist - Clinical Indication II Degree: Masters in Genetic Counseling, MD, or PhD in clinical medicine, genetics, molecular biology, or equivalent. 2-4 years of experience with Human Phenotype Ontology (HPO)-related work and/or clinical experience. Rank: Clinical Genomic Scientist - Clinical Indication III Degree: Masters in Genetic Counseling, MD, or PhD in clinical medicine, genetics, molecular biology, or equivalent. 4-6 years of experience with Human Phenotype Ontology (HPO)-related work and/or clinical experience. Thorough understanding of American College of Medical Genetics (ACMG) variant curation guidelines. Track record of high quality and leading projects toward goals Rank: Clinical Genomic Scientist - Clinical Indication - Senior Degree: Masters in Genetic Counseling, MD, or PhD in clinical medicine, genetics, molecular biology, or equivalent. 4-6 years of experience with Human Phenotype Ontology (HPO)-related work and/or clinical experience. Thorough understanding of American College of Medical Genetics (ACMG) variant curation guidelines. Track record of high quality, leading projects toward goals, training coworkers, demonstration of workflow process improvement Competencies: Quality Assurance, Analytical and Problem-Solving Skills, Technical Skills, Interpersonal Skills, Oral and Written Communication, Teamwork, Organizational Support, Safety and Security, Dependability, Innovation, Adaptability. Physical Demands and Work Environment: At your Home Office: Frequently required to sit, using screen, keyboard, and mouse. Punctuality attending virtual meetings Occasional weekend rotation may be needed (for example, once a month)
    $118k-155k yearly est. 20d ago
  • Clinical Coordinator - Main Operating Room

    Boston Children's Hospital 4.8company rating

    Boston, MA jobs

    We are seeking a Clinical Coordinator to join the team within our Main Operating Room in Boston. Key Responsibilities: Leading, mentoring, and developing a high-performing team to ensure quality patient care and a positive work environment. Providing coaching, feedback, and professional development opportunities to team members to enhance staff skills and career growth. Creating an inclusive, collaborative, and supportive team culture that promotes engagement, accountability, and continuous learning. Overseeing daily clinical and administrative operations, including staff scheduling, resource allocation, and facilitating coordination of care/service. Developing, recommending, and implementing internal standards, policies, and procedures to improve quality and cost-effectiveness of patient care. Selecting, supervising, and evaluating nursing and clinical support personnel to develop and provide staff education/development programs. Leading and participating in hospital, departmental, and multidisciplinary programs, committees, and special projects. Collaborating seamlessly across disciplines, working closely with each member of the team. Minimum Qualifications Education: A Bachelor of Science in Nursing. Master's Degree in Nursing preferred. Experience: A minimum of 4 years of Operating Room experience as an RN. Pediatric Operating Room RN experience preferred. Licensure/ Certifications: Current Massachusetts license as a Registered Nurse RN *$20,000 sign-on for RNs with over 2 years of OR experience who have not worked at BCH in 2+ years* *This position is eligible for a $10,000 Employee Referral Bonus for internal employees* *Additional $8/hour incentive for all hours worked after orientation is completed* The posted pay range is Boston Children's reasonable and good-faith expectation for this pay at the time of posting. Any base pay offer provided depends on skills, experience, education, certifications, and a variety of other job-related factors. Base pay is one part of a comprehensive benefits package that includes flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.
    $8 hourly 12h ago
  • Clinical Research Associate I (Hybrid, Per Diem) - Thai & Asian Community Health Initiatives

    Cedars-Sinai 4.8company rating

    Los Angeles, CA jobs

    This is a hybrid per diem position offering flexibility to work between 0 and 40 hours per week, depending on departmental needs. Scheduling will be determined by the hiring manager in alignment with operational priorities. At this time, we can only consider applicants who are able to commute to our Los Angeles work location several times per week and who reside within a reasonable commuting distance. The hybrid schedule typically consists of two remote workdays and three days spent either onsite or in the field, based on project and program requirements. Preferred Qualification: Proficiency in the Thai language is strongly preferred. Please note that per diem team members are not eligible for health benefits, but this role provides an excellent opportunity to gain valuable experience, contribute to meaningful work, and enjoy a flexible schedule. Cedars-Sinai's Cancer Research Center for Health Equity (CRCHE) and Community Outreach & Engagement team are seeking a passionate and community-oriented Clinical Research Coordinator (CRC I) - Per Diem to support the implementation of the ASPIRE (Asian American Prospective Research) study. This important initiative focuses on advancing community-based research within the Thai community, helping to improve cancer prevention, screening, and health outcomes. In this role, you will play a key part in developing community partnerships, engaging participants, and ensuring the successful implementation of ASPIRE's goals through culturally responsive outreach and collaboration. The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care. Primary Duties and 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. Department Specific Duties & Responsibilities 5% - Works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to support the coordination and implementation of non-complex research studies. 5% - Collects, evaluates, and abstracts clinical research data; may assist in designing data collection/abstraction tools. Enters and processes clinical research data into sponsor-provided Electronic Data Capture (EDC) systems. 5% - Completes Case Report Forms (CRFs) in accordance with study protocols and sponsor requirements. 5% - Assists with prescreening potential research participants for various clinical trials. Schedules participants for research visits and procedures. Provides supervised patient contact or independent contact for long-term follow-up participants. 5% - Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB), including the submission of Adverse Events, Serious Adverse Events, and Safety Letters per federal and local guidelines. 5% - Assists with clinical trial budgets, study-related billing, and patient research billing activities. 5% - Prepares and ships biological samples; maintains study supplies, kits, and inventory. 5% - Ensures compliance with study protocols, Good Clinical Practice (GCP), FDA regulations, IRB requirements, HIPAA standards, and all institutional and federal guidelines. Maintains strict patient confidentiality. 5% - Serves as a point of contact for external sponsors for select trials; responds to sponsor inquiries and may attend meetings regarding study activity under supervision. Additional Study-Specific Duties Pulmonary Function Lab Assists with prescreening of potential study participants. Maintains organized paper and electronic research files. Assists with preparing manuscripts, correspondence, and other research documents. Conducts literature reviews to support study activities. Neuroscience Transports research medications according to protocol requirements. Performs study-related assessments and participant questionnaires. Maintains organized paper and electronic research files. Assists with manuscript preparation and other research documentation needs. Conducts literature reviews for ongoing and upcoming studies. QualificationsRequirements: High School Diploma/GED required. Preferred: Bachelor's Degree preferred. Proficiency in the Thai language is strongly preferred. 1 year Clinical research related experience preferred. Req ID : 13883 Working Title : Clinical Research Associate I (Hybrid, Per Diem) - Thai & Asian Community Health Initiatives Department : Cancer - Research Center Health Equity Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Research Studies/ Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $24 - $32.86
    $24-32.9 hourly 1d ago
  • Clinical Research Manager, Research Operations

    Cedars-Sinai 4.8company rating

    Beverly Hills, CA jobs

    Responsible for the daily planning, organizing, directing and controlling of the operations of assigned area, in order to meet the needs of all customers, Faculty and support of Medical Center goals and philosophies. The Manager, Research Operations assumes fiscal responsibility through preparation of unit budgets, serves as liaison with Faculty and other personnel, promotes the maximum growth and development of each employee, supports research, participates in both strategic and tactical planning. The Manager, Research Operations is accountable to the Department Chair and/or Institute Executive Director and serves as the primary source of information for the department. She/he maintains competency skills including the ability to interact with Faculty and staff within their assigned area, the Medical Center and throughout the Health System. The Manager, Research Operations plans, organizes, manages and controls the daily operations of their area and works closely with departmental leadership, Faculty, Principal Investigators (PIs), staff and students to provide analytical support and project management in fulfilling the established goals and objectives for the department and organization. Strategizes and collaborates with the Director and senior leadership, along with Academic Affairs regarding development and implementation of policies and procedures. Manages and supervises administrative staff; provides leadership coaching, and opportunities for professional development. The Manager, Research Operations facilitates Human Resource (HR) functions for their area by collaborating with the appropriate HR partners for Faculty and department staff recruitment, visa and immigration assistance, employee relations, compensation, and benefits. Primary Duties and Responsibilities Ensures compliance with state and federal laws, accreditation, professional and regulatory agency standards and licensure requirements. Maintain staff compliance with medical center policies, procedures and protocols. Assumes fiscal responsibility for the department including unit budget preparation, labor and supply cost management, and revenue enhancement. Responsible for tracking and reporting all high-level Capital/Operations projects. Prepares complex or highlevel regular and ad-hoc financial reports for the Department Chair and/or Institute Executive Director. Works closely with leadership to develop processes and tools to monitor research funding and activities for the area. In collaboration with the Department Chair, Institute Executive Director and/or Division Director develops business operations plans for department and for specific programs and services within it. Supervises the research protocols as mandated for research and ensures optimal levels and continuous improvement of quality within their work area. Maintains appropriate quality management and oversight programs. Supervises department employees, including responsibility for determining qualifications, hiring, maintaining and improving competence, assigning work, coaching, training (e.g. orientation, in-service and continuing education), evaluating performance, compensation, discipline and terminating employment. Interact regularly with PIs and staff to assess team needs, provide information and resolve issues. Promote a team atmosphere and manage staff regarding but not limited to the following: Manage the onboarding of new lab staff, Develop job descriptions, Conduct employee annual appraisals, Identify staffing needs, Conduct probationary period meetings with new staff, and Counsel, coach and terminate staff as appropriate. In collaboration with the Institute Executive Director and/or Division Director, develops business and operations plans for department and for specific programs and services within it. Manages the effective utilization of human resources and supplies within the department, including the development of appropriate staffing and management of productivity. Develop staffing plans in response to research and department activity. Recommend space and other resources for needed services. Participate in the selection of outside sources for needed services. Collaborates with other research, department and clinical/support service managers in other areas to help foster cross-functional process improvement, collaborative teamwork, open communication and problem solving to ensure the effective coordination and integration of services within and between units. Works closely with the Office of Research Administration and designated Research Grant Specialist to ensure all grant awards are appropriately managed and maintained for Faculty holding a primary appointment in the area. Responsible for facilitating the Faculty contracting process in coordination with Academic Human Resources. Performs all other duties as assigned. Department-Specific Responsibilities The successful candidate will provide strategic leadership and operational oversight for the Cancer Clinical Trials Office (CCTO), ensuring the highest standards of regulatory compliance, operational excellence, and program growth across Cedars-Sinai and the Samuel Oschin Cancer Center. Clinical Operations & Regulatory Oversight Provide leadership to ensure all clinical research activities comply with institutional, local, state, and federal regulations, including GCP, ICH, IRB, and NCI/CCSG requirements. Oversee the structure, governance, and operational alignment of the CCTO with Cedars-Sinai Medical Center and the Samuel Oschin Cancer Center. Ensure accuracy, quality, and timely reporting of clinical trial data across all CTMS, databases, and tracking systems, including adverse events, serious adverse events, and protocol deviations. Perform routine quality checks and audits in collaboration with Quality Management to maintain robust QA/QC programs and support internal and external monitoring visits. Program Leadership & Strategic Planning Partner with Principal Investigators, disease teams, and CCTO leadership to advance clinical research initiatives, improve trial activation timelines, and increase patient accrual. Generate and oversee protocol status reports and performance metrics for key stakeholders, including leadership, IRB, and clinical teams. Lead initiatives to improve efficiency, streamline workflows, enhance communication, and support continuous process improvement across clinical research operations. Support expansion of Cedars-Sinai's cancer clinical research programs across the broader cancer network in collaboration with institutional leadership. People Management & Team Development Lead, mentor, and evaluate clinical research staff, including hiring, onboarding, workload management, performance evaluations, and professional development. Standardize training, tools, and processes across the Clinical Operations Unit to ensure consistency and operational excellence. Foster an inclusive, collaborative, and high-performing team culture that supports professional growth and accountability. Financial & Resource Management Oversee clinical trials financial resources, including budget development, monitoring, and forecasting in collaboration with CCTO and SOCCI finance leadership. Prepare and distribute operational and financial reports, including accrual metrics, audit activity, activation timelines, and budget performance. Support enterprise-wide research administration initiatives and serve as a pilot for scalable clinical research support services as appropriate. Stakeholder Engagement & Communication Serve as a liaison between sponsors, CROs, disease teams, and institutional partners to ensure timely communication and resolution of protocol-related issues. Build and maintain strong relationships with internal and external stakeholders, representing Cedars-Sinai with professionalism and integrity. Teamwork, Leadership & Customer Relations Collaborates effectively across multidisciplinary teams to solve problems and achieve shared goals Establishes strong, trust-based relationships with stakeholders and customers Demonstrates responsiveness, accountability, and inclusive practices Shares expertise and supports team success across functions Supervisory & Management Responsibilities Directly supervises staff, including hiring, scheduling, performance management, and corrective action as needed Plans and assigns work to ensure objectives are met within budget and timelines Provides day-to-day leadership, guidance, and oversight to ensure high-quality outcomes Qualifications REQUIREMENTS Bachelor's Degree in Business, Administration, Nursing, or equivalent work experience required 5 years of related supervisory or management experience, with increasing responsibility Preferred Qualifications: Master's Degree (MBA or MPH) strongly preferred 2 years of experience in finance or budget oversight. Knowledge of general accounting and financial analysis. Knowledge of GAAP rules helpful Req ID : 12570 Working Title : Clinical Research Manager, Research Operations Department : Cancer - SOCCI Clinical Research Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Academic/Research Services Overtime Status : EXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $55.31 - $96.79
    $55.3-96.8 hourly 1d ago
  • Clinical Research Program Manager (Operations)

    Cedars-Sinai 4.8company rating

    Beverly Hills, CA jobs

    Responsible for directing and managing a specified program within the clinical research operations unit, department, or division. Provides leadership, guidance and direction for the day-to-day clinical research operations and activities, including authority to make independent decisions regarding program operations, administration, and governance. Ensures compliant, efficient, and effective conduct of the clinical trials within the portfolio. Establishes, implements, and evolves operational standards and monitors quality and progress of the program(s). Primary Duties and Responsibilities Oversees and/or manages the assigned recognized organizational clinical research program and has authority for day-to-day program operations and administration. May be responsible for program development or expansion. Plans and implements program operations, determines and develops governance, processes and/or guidelines, coordinates program activities and timelines, and determines and organizes resources to meet program objectives. May manage the research study intake process, including feasibility, review and endorsement and PRMC submission, as well as capturing all trials declined by program or department leadership. Identifies and defines any logistics, action items, changes, or information needed to effectively manage the program. Identifies barriers to timely study activation, efficient coordination, and participate to identify/implement potential solutions. May identify program participants and lead cross-functional teams in the administration, maintenance or expansion of the program. Interfaces with internal and external key stakeholders including other departments, leaders across the organization, representatives from external agencies/organizations in the management of the program to provide guidance, resolve issues, grow the program, and/or implement processes and/or solutions. Identifies growth opportunities and further efficiencies that impact the program and/or departments success and aids in development of strategic plans to achieve objectives. Manages study intake process, evaluates feasibility, and providing recommendations or making decisions to support the success of the clinical research program. Interfaces with internal/external stakeholders to maintain and further develop program growth, community outreach activities, as well as relationship building and maintenance. Researches and analyzes data for evaluating performance of program or program operations, including quality assurance and trends. Makes recommendations to leadership and/or implements program changes based on findings. Provides data and/or summary findings to program participants, stakeholders, leadership, and/or cross-functional teams. Performs quality oversight of clinical trials to include monitoring progress of screening, enrollment, and data submission. Responsible for ensuring protocol compliance and training of staff supporting the program. Plans and supports the department/program leaders during an audit, to include direction for audit prep and any required follow up post audit. Evaluates requests for program exceptions or changes, and determines response, escalating as necessary. Assesses communication and training needs, develops and implements any applicable communication, education, training, on-boarding and/or mentorship pertaining to the program. Provides regular Primary Duties and Responsibilities communication to departments and leaders across the organization. Notifies stakeholders of any changes to the program. May work with cross-functional teams across multiple departments to develop communication and training materials. In conjunction with leadership, responsible for planning, monitoring, and managing program fiscal budgets and financials, and resolves or escalates issues. Maintains data system integrity and ensures quality assurance measures are followed based on departmental standard operating procedures. May provide ad hoc reporting to support recommendations observed through trend analysis for future planning and enhancements. Monitors program to ensure appropriate governance and program compliance with local, state and federal laws; accreditation, professional and regulatory agency standards and licensure requirements. Maintains staff and program compliance with organizational policies and procedures. Monitors compliance reporting tools and provides summary status reports to the Research Manager, and other stakeholders. May manage staff and/or lead the work of others, including some or all of the following: recruitment, onboarding/off-boarding, training, performance management and professional development of staff. Department-Specific Responsibilities Manage Disease Research Group (DRG) Meetings: Lead and coordinate DRG meetings, ensuring that all necessary information is addressed to support DRG functions. Maintain regular communication with DRG faculty to ensure alignment with DRG needs and future planning. Clinical Issue Resolution: Engage with providers (physicians, advanced practice providers, clinic nurses, and staff) to ensure that clinical issues are identified and addressed promptly and in compliance with policies. Promote Research Excellence: Advance clinical research activities in a safe, compliant, effective, efficient, and collegial manner. Training and Development: Oversee the training and education of clinical research staff within the DRG/team. Conduct baseline competency assessments for new hires, identify areas of opportunity, and develop individualized training plans. Provide ongoing management of staff development, including competency assessments and continued education opportunities. Contribute to the development and delivery of educational in-services to ensure high-quality clinical research performance. Compliance and Quality Oversight: Contribute to the development and monitoring of corrective action plans. Ensure compliance with Cedars-Sinai, CCTO, and SOCCI policies and procedures. Strategic Leadership: Actively participate in the strategic planning process of SOCCI's Cancer Clinical Trials Office (CCTO). Represent the CCTO on university and hospital committees and task forces as assigned. Clinical Study Coordination: Independently coordinate studies, including patient screening, informed consent (when IRB- and Nursing Institute-approved), and oversight of study assignments within the group. Supervise research staff and ensure compliance with federal and local regulations, including FDA and IRB requirements. Develop and implement strategies to increase patient enrollment, improve efficiency, train personnel, and identify new research opportunities. Specimen and Clinical Services: Coordinate study participant tests and procedures as required, and handle research specimens (processing, shipping, tracking). Perform phlebotomy services in accordance with CSMC policies and procedures, ensuring accurate specimen labeling and reporting of results. Other Duties: Perform additional responsibilities as assigned to support departmental goals. Qualifications Required Qualifications High School Diploma or GED. Minimum 5 years of experience in management, program/project management, or a related field. Minimum 3 years of experience in a clinical research or related industry setting. Demonstrated experience managing a team, including direct supervision of staff, in a clinical research setting. Familiarity with clinical research operations, including regulatory compliance, study coordination, and staff development. Preferred Qualifications Bachelor's degree in healthcare, management, or a related field. At least 1 year of experience managing clinical trial operations. Req ID : 11205 Working Title : Clinical Research Program Manager (Operations) 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 : $45.56 - $77.45
    $45.6-77.5 hourly 1d ago
  • Clinical Research Associate I - Heart Institute

    Cedars-Sinai 4.8company rating

    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 Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care. Primary Duties & Responsibilities: Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study. Evaluates and abstracts clinical research data from source documents. Ensures compliance with protocol and overall clinical research objectives. Completes Case Report Forms (CRFs). Enters clinical research data into Electronic Data Systems (EDCs) that the sponsors provide. Provides supervised patient contact or patient contact for long term follow-up patients only. Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines. Assists with clinical trial budgets. Assists with patient research billing. Schedules patients for research visits and research procedures. Responsible for sample preparation and shipping and maintenance of study supplies and kits. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs. Qualifications Education: High School Diploma is required. Bachelor's degree preferred in Science, Sociology, or a related field. Experience and Skills: One (1) year of clinical research related experience is preferred. Ability to interpret and apply knowledge of State, Federal, and Agency standards to comply with regulations. Ability to convey and/or receive written/verbal information to/from various audiences in different formats. About UsCedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents. About the TeamCedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most. Req ID : 9188 Working Title : Clinical Research Associate I - Heart Institute Department : Heart Institute Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Research Studies/ Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $24 - $32.86
    $24-32.9 hourly 1d ago
  • Clinical Research Associate II - Women's Research Program - Full-Time, On-Site

    Cedars-Sinai 4.8company rating

    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 : $24 - $36.14
    $24-36.1 hourly 1d ago
  • Clinical Research Associate I - Yang Lab - Karsh Division of Gastroenterology and Hepatology

    Cedars-Sinai 4.8company rating

    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 Clinical Research 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 Clinical Research Associate I, you will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. This role evaluates and abstracts research data and ensures compliance with protocol and research objectives. This position will be responsible for completing case report forms (CRFs), entering clinical research 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 clinical research objectives. 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) 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: Clinical research 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 : Clinical Research 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, Thoracic (Hybrid)

    Cedars-Sinai 4.8company rating

    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
    $28.3-48.1 hourly 1d ago
  • Clinical Research Coordinator I - Department of Neurology (Hybrid)

    Cedars-Sinai 4.8company rating

    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 : $24 - $39.76
    $24-39.8 hourly 1d ago
  • Clinical Research Coordinator II, Thoracic (Hybrid)

    Cedars-Sinai 4.8company rating

    Los Angeles, 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. #Jobs-Indeed Req ID : 8277 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
    $28.3-48.1 hourly 1d ago
  • Research Associate II - The Angeles Clinic & Research Institute

    Cedars-Sinai 4.8company rating

    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. Why work here? Beyond an outstanding benefits package and competitive salaries, we take pride in hiring the best, most committed employees. Our staff reflects the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a multifaceted, inclusive environment that fuels innovation and the gold standard of care we strive for. Join our team and contribute to groundbreaking research. The Research Associate II works at a high level of excellence and commitment to perform a wide variety of activities integral to the successful management and administration of essential regulatory documents. The Research Associate II is responsible for ensuring timely submission of complete, accurate and current documents to research sponsors, IRBs, and contract research organizations, where applicable. Primary Duties and Responsibilities: Submits research projects (protocols, consent forms, recruitment materials, IRB application, etc.) for human subjects' approval. Submits appropriate internal documentation for contract execution. Maintains communication with contracting officers and sponsors of research during the budgeting and negotiating process. Develops research project budgets based on protocol requirements and Cedars-Sinai published research costs, ensuring that all anticipated costs are appropriately accommodated and that research protocol, research budget and research subject informed consent documents are consistent. Monitors study payments and generates invoices as necessary to ensure adequate funding throughout the course of the trial. Ensures timely filing of annual renewals and amendment submissions to IRB. Ensures the completion and maintenance of consent forms, case report forms, SAE's and source documents to ensure that research is being conducted according to IRB, FDA, OHRP, HIPAA and other agency guidelines. Maintains high quality, up-to-date regulatory files (CITI and other training documents, financial disclosures, FDA forms, CVs, medical licenses, etc.) for research studies. Completes appropriate IRB paperwork and submits internal and external Serious Adverse Events (SAEs) and INDSRs to IRB. May help coordinate and prepare for institutional, pharmaceutical and internal audits. Coordinates site feasibility visits and site initiation visits for potential studies. Completes feasibility questionnaires. Provides facility tours to visiting research sponsors, CROs, and other personnel for research-related activities. Coordinates and collaborates with internal and external investigators and participating centers in multi-center studies to achieve research goals. Participates in weekly research staff meetings. Protects rights and research data of research volunteers, including medical records, data, etc. Obtains necessary consent forms, or HIPAA information forms as needed, in research process. Performs administrative duties in a timely manner as assigned. Qualifications Requirements: High School Diploma/GED required. Bachelor's degree preferred. 1 year Clinical research related experience required. #Jobs-Indeed #LI Req ID : 13668 Working Title : Research Associate II - The Angeles Clinic & Research Institute Department : Angeles Research Inst Business Entity : Cedars-Sinai Medical Care Foundation Job Category : Academic / Research Job Specialty : Research Studies/ Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $24 - $34.64
    $24-34.6 hourly 1d ago
  • Clinical Research Associate I - Medically Associated Science & Technology (MAST) Program

    Cedars-Sinai 4.8company rating

    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 Clinical Research Associate I, you will work 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 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 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). 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 clinical research 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 clinical research 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 : Clinical Research 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 - Heart Institute - Makkar Lab

    Cedars-Sinai 4.8company rating

    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 Clinical Research Associate I works under the supervision of Principal Investigator and Research Scientist Dr. Raj Makkar and 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 : 13060 Working Title : Clinical Research Associate I - Heart Institute - Makkar Lab Department : Heart Institute Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Research Studies/ Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $24 - $32.86
    $24-32.9 hourly 1d ago
  • Clinical Research Associate I - Butte Lab - Department of Neurosurgery (Per Diem)

    Cedars-Sinai 4.8company rating

    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! Dr. Pramod Butte, Ph.D. is looking for a Clinical Research Associate I to join a diverse team! The primary focus of the Butte Laboratory is translational research in the field of bio-photonics. The Butte Lab is developing novel intra-operative imaging/visualization technologies to aid surgeons in achieving near-complete tumor excision. To learn more about the Butte Lab, please visit this website. Serving as a Clinical Research Associate at Cedars-Sinai, you will assist in the effort in validating the clinical trial of groundbreaking medical imaging systems. The job will provide an outstanding opportunity to work with a multidisciplinary team involving optical engineers, mechanical engineers, electrical engineers, biomedical engineers as well as surgeons, pathologists, and other medical personnel. You will be involved in the development and possible commercialization of a novel medical device technology. Interest or experience in a start-up environment with an entrepreneurial spirit is highly desired. The position will provide experience as a part of a highly focused team on a broad array of technologies. In addition, the position will also offer experience with other technicians, with clinical trials, collecting clinical data, and play a crucial part in developing clinical protocols. The position will provide opportunity to work on medical technology with far reaching and immediate impact on patients' lives. The CRA I member will work directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. This role evaluates and abstracts research data and ensures compliance with protocol and research objectives. Position is responsible for completing case report forms, provides limited patient contact as needed for study, and assists with study budget and patient research billing. This role will follow all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care. Primary Job Duties and Responsibilities: Schedules patients for research visits and research procedures. 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. Responsible for sample preparation and shipping and maintenance of study supplies and kits. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs. Department-Specific Duties and Responsibilities: Obtains patient consent, if authorized, to participate in clinical study. Engages with OR staff to ensure informed, accurate, and timely transport, scanning, and processing of specimens in the context of the clinical study. Works with, handle, and process fresh and fixated specimens per outlined protocol Perform scanning of specimens using clinical prototypical imaging device(s). Performs transport, set-up, tear-down of clinical equipment used in clinical study. Qualifications Education: High School Diploma or GED, required. Experience and Skills: Understanding of general research objectives. Experience in a clinical research setting is highly 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 : 8933 Working Title : Clinical Research Associate I - Butte Lab - Department of Neurosurgery (Per Diem) Department : Research - Neurosurgical 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 - Community & Behavioral Health, Tan Lab (Onsite)

    Cedars-Sinai 4.8company rating

    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. Please note that a cover letter is required as part of the application. The cover letter should explain your interest in this opportunity and how it aligns with your career goals. Applications missing this document will not be considered. Cedars-Sinai has an outstanding opportunity for an independent and well-organized contributor to serve as a CLINICAL RESEARCH ASSOCIATE to Dr. Judy Tan to support community-engaged research that develops behavioral and community-based health interventions for LGBTQ+ communities of color. Dr. Tan, Associate Professor, Cancer Research Center for Health Equity, Division of Population Sciences, Department of Biomedical Sciences, is a social psychologist and applies her training in behavioral and prevention sciences to develop innovative interventions for improving health outcomes among marginalized populations in the U.S. This position provides contributions to behavioral and implementation science for the Cancer Research Center for Health Equity. The scope of the work includes research involving participants recruited from the surrounding LA communities and interactions with community-based researchers, academic researchers, and local community organizations and health systems. As Clinical Research Associate, you will be a vital member of an interdisciplinary team led by Dr. Tan, which includes a biostatistician, qualitative data researchers, as well as grant administrative and project management support staff members. Your role will be assisting with both quantitative and qualitative research projects, patient research engagement, and community liaison support. You will take lead roles on project activities, as identified by the team. Data management, coordination, and analysis: (30%) Assist with leading the creation and management of organized research project portfolio with project dashboard for data tracking. Work independently to produce tables, charts, graphs for manuscript and grant preparation from sources including analyst reports, publicly available data, and literature searches. Organize data storage and management for qualitative study (including interviews with cancer patients, caregivers, and affected community members). Organize data storage and management for quantitative projects. Execute basic data analysis (demographic tables, bivariate calculations, evaluation of missing data) of existing data sets to generate research approach and analytic plans. Support process evaluation of a pilot smoking cessation program, including developing evaluation framework, creating and implementing a data collection plan. Human subject research support: (20%) Assist with leading the creation and management of study questionnaires in REDCap. Identify and resolve quality issues with survey administration. Manage revisions of REDCap instrument and protocol. Triage data collection questions for immediate resolution or consultation with team, PI. Assist with leading the development and submissions of IRB study applications, modifications, and renewals. Assist with leading the compliance efforts for sponsoring entities. Patient and stakeholder engagement: (20%) Support the relationship (act as primary liaison) with community partners, through meeting scheduling, regular and proactive email communication, phone calls, and in-person meetings. Support collaboration with community partners to develop and assess project implementation strategies, including outreach strategies, project materials, and workshop content. Manage collaborative curriculum adaptation with multiple community partners. Interact with patients via assisting with qualitative interviews and focus groups. Writing & Grant Development (10%) Assist with leading the development of project narrative/research plans for new grants, including timelines and schedules of deliverables. Write portions of manuscripts in collaboration with the research team and community partners. Provide copy-editing assistance with manuscripts. Conduct independent literature searches and produce summaries to guide project development based on ongoing research findings and future steps. Budget Management (5%) Act as PI proxy in grant expense approvals and FTE certification. Collaborate with department payroll and grant management staff to identify and address any expense errors. Reconcile budgets monthly. Create budget projections; identify budget surplus and deficits. Ensure timely payment of community partner and other service provider invoices. Assess appropriate budgets to charge for new research activities. Website development & management (5%) Develop content for website. Edit content according to stakeholder (community partners') feedback) Edit personal testimonial videos. Respond to and track website inquiries. Act as the primary liaison with graphic designer and web developers. Other administrative duties as needed (5%) Support Dr. Tan and project team with scheduling meetings Plan and co-manage event logistics; act as primary liaison with on-site service providers. Qualifications This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace. Please note that hybrid or remote work options are NOT available for this position at this time. Please note that a cover letter is required as part of the application. The cover letter should explain your interest in this opportunity and how it aligns with your career goals. Applications missing this document will not be considered. Requirements: High School Diploma or GED required A cover letter explaining your interest in this opportunity and how it aligns with your career goals Resume or CV Preferred: Bachelor's degree or equivalent experience in public health or related area. At least 2 years of related experience post-undergraduate degree. Excellent verbal and written communication skills. Working knowledge of community-based research and organizing theories, frameworks, principles, and practices. Experience with program evaluation, specifically process evaluation. Experience managing complex, multi-stakeholder projects. Experience working with marginalized populations related to health issues. Strong interest in minority health & healthcare, racial disparities, social determinants of health with self- motivation for independent learning Commitment to racial and LGBTQ+ justice. Bachelor's level or equivalent analytic skills and understanding (SAS, Stata, R or equivalent). Intermediate or higher level skills of MS Office suite. Interview Process: If selected for an interview, candidates may be asked to complete a brief writing sample and/or a short example exercise or task relevant to the position. Req ID : 10622 Working Title : Clinical Research Associate I - Community & Behavioral Health, Tan Lab (Onsite) Department : Cancer - Research Center Health Equity Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Research Studies/ Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $24 - $32.86
    $24-32.9 hourly 1d ago
  • Clinical Research Associate I - Urology

    Cedars-Sinai 4.8company rating

    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 : $24 - $32.86
    $24-32.9 hourly 1d ago
  • Surgery Chair Clinical Research Coordinator II

    Cedars-Sinai 4.8company rating

    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
    $58.9k-100.1k yearly 1d ago
  • Surgery Chair Clinical Research Coordinator II

    Cedars-Sinai 4.8company rating

    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
    $58.9k-100.1k yearly 1d ago
  • Clinical Research Coordinator I - Guerin Children's - Pizzo Lab - Full-Time, On-Site, Days

    Cedars-Sinai 4.8company rating

    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 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. 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 : Clinical Research Coordinator I - Guerin Children's - Pizzo Lab - Full-Time, On-Site, Days Department : Research - Pediatrics Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Research Studies/ Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $24 - $39.76
    $24-39.8 hourly 1d ago

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