Cedars-Sinai Clinical Research Coordinator II - Psychiatry - Dr. Waguih IsHak Lab in Los Angeles, California
Cedars-Sinai employs more 800 people involved
in research, including over 100 principal investigators leading sponsored
research projects. We rank among the top
ten non-university hospitals nationwide receiving research funding from the
National Institutes of Health (NIH). Our
scientists have earned grant awards at organizations such as the Department of
Defense, National Institutes of Health, and the American Heart Association.
As the Clinical Research Coordinator II within the Department of Psychiatry and Behavioral Neurosciences under the direction of Dr. Waguih IsHak, Vice Chairman for Education and Research and Consultant Psychiatrist as well as the Research Manager, you will work independently and in collaboration with clinical investigators providing study coordination including screening of potential research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documentation, data collection, data entry, and data 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 this information at regular research staff meetings.
You may plan, coordinate, and participate in strategies for increasing research participant enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Responsible for scheduling research related meetings and recording and distributing minutes from meetings. May be responsible for drafting clinical research Standard Operating Procedures. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local and central Institutional Review Board (IRB). Works with department research administrator on budget development as it relates to study specific procedures and responsible for patient research billing reconciliation.
Essential job duties and responsibilities:
Independent study coordination including pre-screening of potential research participants for protocol eligibility, presenting non-medical trial concepts and details to the research participants, and participating in the informed consent process.
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) the following; changes in research participant 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 initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May involve other regulatory / Institutional Review Board duties, budgeting duties, and assisting with research participant 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 research participant confidentiality according to HIPAA regulations and applicable law. Coordinates training and education of other personnel.
Participates in centralized activities such as auditing, Standard Operating Procedure development, etc. Plans, coordinates, and participates strategies for increasing research participant enrollment, and/or improving clinical research efficiency.
Identifies quality and performance improvement opportunities and collaborates 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.
This is a .75 full-time position.
Education and experience requirements:
- BA/BS degree
- ACRP/SoCRA (or equivalent) certification preferred
Four (4) years minimum of directly related experience in the field of clinical trial coordination
Must have strong MS Office computer skills, data extraction and entry skills, conduct Internet searches, and ability to become proficient using related organizational and sponsor software programs
Cedars-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.