Job DescriptionGuerin Children’s is launching an innovative program in pediatric epilepsy and neurogenic rare diseases, including genomic sequencing and clinical trials with advanced therapy medicinal products (ATMPs).The Clinical Research Coordinator III works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for oversight of all studies with the Pediatric Neurology/Neurosurgery clinical trials group and the assignment of studies to clinical research personnel within the group, and supervision of research staff. Plans and coordinates IRB submission, clinical trial plans and costing, strategies for increasing patient enrollment, improving efficiency, training of personnel, and identifying new research funding 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
Scheduling of patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May involve other regulatory / IRB 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.
Works with Training and Education Coordinator to ensure all staff is properly trained and certified.
Participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
Plans and coordinates strategies for increasing patient enrollment, and/or improving clinical research efficiency.
Identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
Identifies new research opportunities and presents to investigators.
Supervises other research staff.
QualificationsQualifications:
High School Diploma/GED required. Bachelor's or Master's Degree in Science, Sociology, Nursing or related degree preferred.
Four (4) years of clinical research related experience required.
No license or certification 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 : 646Working Title : Clinical Research Coordinator III - Guerin Children's - Pediatric Neurology/Neurosurgery (Full-Time, On-Site)Department : Research - Peds GeneralBusiness Entity : Cedars-Sinai Medical CenterJob Category : Academic / ResearchJob Specialty : Research Studies/ Clin TrialOvertime Status : EXEMPTPrimary Shift : DayShift Duration : 8 hourBase Pay : $34.24 - $58.21Cedars-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.
