Cedars-Sinai Clinical Research Coordinator III - Technology Ventures Department in Los Angeles, California
Cedars-Sinai’s Technology Ventures protects and supports the
commercialization of discoveries and technologies invented at Cedars-Sinai.
Through its in-house diagnostic development business unit, 3 rd
Street Diagnostics, we work to develop and commercialize diagnostic targets and
biomarkers from both Cedars-Sinai and our international partners.
As a Clinical Research Coordinator III in the Technology Ventures group, you will be responsible for
oversight of all studies for the development of diagnostic tests including
assignment of studies to clinical research personnel within Cedars and at
CROs. Plans and coordinates strategies to meet enrollment targets and
improving efficiency. Ensures compliance with all federal and local
agencies including the Food and Drug Administration (FDA) and local
Institutional Review Board (IRB).
Essential job Duties and Responsibilities:
Responsible for oversight of all studies within the group and the assignment of studies to clinical research personnel within the group. Manages the clinical research portfolio and daily operations of studies for the investigator or disease group.
Independent study coordination including 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.
Participates in required training and education programs.
Works with Training and Education Coordinator to ensure all staff is properly trained and certified.
Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
Plans and coordinates 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.
Identifies new research opportunities and presents to investigators.
Supervises other clinical research staff in day to day operations. Provides input in the performance review of other clinical research staff.
Organizes and leads routine research meetings.
- BA/BS Degree
- ACRP/SoCRA (or equivalent) certification preferred
- Five to seven (5-7) years minimum of directly related experience
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.
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