Clinical Research Coordinator II - Movement Disorders and Stroke Research P at Cedars-Sinai

Los Angeles, California, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Jun, 26

Salary

100068.0

Posted On

21 Mar, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Study Coordination, Screening, Informed Consent Process, Data Collection, Documentation, Reporting, Protocol Compliance, Adverse Events Reporting, IRB Submissions, Good Clinical Practice, HIPAA Compliance, Patient Confidentiality, Case Report Forms, Literature Reviews, Manuscript Preparation, Auditing

Industry

Hospitals and Health Care

Description

Grow your career at Cedars Sinai! Cedars Sinai offers a culture of happiness, passion, and dedication. This is one of the many reasons why we rank as one of the top hospitals in California and in the nation by U.S. News & World Report. About the Teams Our movement disorders research brings together a team of scientists, neurologists and neurosurgeons all with one shared goal: to increase our understanding of these conditions and find better treatment options for patients with movement disorders. Our researchers are involved in preclinical and clinical research studying possible therapeutics including stem cell therapy and deep brain stimulation. The goal of our stroke research is to conduct ground breaking and practice‑changing stroke research, deepening our understanding of the cause of stroke, best strategies for stroke prevention, and enhanced stroke recovery. Note: 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. Do you have a passion for helping human kind? The Clinical Research Coordinator II works 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 II 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 information at research staff meetings and may plan and coordinate strategies for growing research participant enrollment, improving efficiency, training of personnel, or identifying new research opportunities. This position ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board. Primary Duties and Responsibilities: * Scheduling of research participants for research visits and procedures. * In collaboration with the physician and other medical personnel, documents 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. * May participate in centralized activities such as auditing, Standard Operating Procedure development, etc. * May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality. * Maintains accurate source documents related to all research procedures. 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. Cedars-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. Cedars-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.

Responsibilities

The Clinical Research Coordinator II independently manages study coordination, including participant screening, presenting trial concepts, and handling the informed consent process. This role is responsible for accurate and timely source documentation, data management, reporting, and ensuring compliance with FDA and IRB guidelines.