Vacancy caducado!
Job DescriptionDo you have a passion for the highest quality and patient happiness? Then please respond to this dynamic opportunity available with one of the best places to work in Southern California! We would be happy to hear from you.Cedars-Sinai is a partner institution in the UCLA Clinical and Translational Science Institute (CTSI), an academic-clinical-community partnership designed to accelerate scientific discoveries and clinical breakthroughs to improve health in the most populous and diverse county in the United States. Our mission is to create a borderless clinical and translational research institute that brings UCLA innovations and resources to bear on the greatest health needs of Los Angeles. To learn more, please visit: Clinical & Translational Science Institute | Cedars-Sinai .The Clinical & Translational Research Center (CTRC) supports innovative, patient-oriented research, offers clinical research training and recognition programs and provides researchers an environment for seeing patients when they take part in clinical research studies. To learn more, please visit: Clinical & Translational Research Center (CTRC) | Cedars-Sinai .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:
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, and response to study drug.
Maintains accurate source documents related to all research procedures.
Schedules and participates in monitoring and auditing activities
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
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 them to investigators.
Participates in required training and education programs.
QualificationsEducation:
High School Diploma/GED is required. Bachelor of Science, Sociology, or related degree is preferred.
Licenses/Certifications:
Phlebotomy Certification CA is required.
Experience and Skills:
Two (2) years of clinical research related experience and involvement in coordination of clinical research trials is required.
Ability to use discretion and maintain privacy, confidentiality or anonymity.
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.
Must present a professional demeanor and interactions with the research community including research participants and/or family members, leadership, investigators, research nurses, coordinators, research pharmacy, sponsored research staff, and other ancillary service departments.
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 : 749Working Title : Clinical Research Coordinator II/CPT - Clinical & Translational Research Center (CTRC)Department : Research InstituteBusiness Entity : Cedars-Sinai Medical CenterJob Category : Academic / ResearchJob Specialty : Research Studies/ Clin TrialOvertime Status : EXEMPTPrimary Shift : DayShift Duration : 8 hourBase Pay : $58,864 - $100,068.80Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.
Vacancy caducado!