Cedars-Sinai Clinical Research Coordinator II - Smidt Heart Institute - Cheng Lab in Los Angeles, California
As a Clinical
Research Coordinator II, you will work independently 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 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 this
information at regular research staff meetings. May plan and coordinate
strategies for increasing research participant 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).
Independent studycoordination including screening of potential research participants forprotocol eligibility, presenting non-medical trial concepts and details to theresearch participants, and participating in the informed consent process.
Scheduling ofresearch participants for research visits and procedures.
Incollaboration with the physician and other medical personnel, documentsthoroughly on Case Report Forms (CRFs) the following; changes in researchparticipant condition, adverse events, concomitant medication use, protocolcompliance, response to study drug.
Maintainsaccurate source documents related to all research procedures.
Responsible foraccurate and timely data collection, documentation, entry, and reportingincluding timely response to sponsor queries.
Schedules andparticipates in monitoring and auditing activities.
Responsible forcompiling and reporting on each study including information related to protocolactivity, accrual data, workload, and other research information; present thisinformation at regular research staff meetings.
Notifies directsupervisor about concerns regarding data quality and study conduct.
Works closelywith a regulatory coordinator or directly with the Institutional Review Board(IRB) to submit initial applications, amendments, continuing reviews, AdverseEvents, Serious Adverse Events, protocol deviations, and Safety Letters inaccordance with local and federal guidelines.
May involveother regulatory / Institutional Review Board duties, budgeting duties, andassisting with research participant billing and reconciliation.
Ensurescompliance with all federal and local agencies including the Food and DrugAdministration (FDA and local Institutional Review Board.
Maintainsresearch practices using Good Clinical Practice (GCP) guidelines.
Maintainsstrict research participant confidentiality according to HIPAA regulations andapplicable law.
Coordinatestraining and education of other personnel.
Participates incentralized activities such as auditing, Standard Operating Proceduredevelopment, etc.
Plans andcoordinates strategies for increasing research participant enrollment, and/orimproving clinical research efficiency.
Identifiesquality and performance improvement opportunities and collaborates with staffin the development of action plans to improve quality.
May identifynew research opportunities and present to investigators.
Participates inrequired training and education programs.
- BA/BS Degree is required
CaliforniaCertified Phlebotomy Technician I or Certified Phlebotomy Technician IIcertification, or a valid California Nursing License.
ACRP/SoCRA (orequivalent) certification preferred.
- Four (4) yearsminimum 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.