Clinical Research Coordinator II - Guerin Children's - Pediatric Neurology - Full-Time, On-Site, Days
Cedars-Sinai · Los Angeles, California
What the posting says
Each fact was read from this posting and checked:Statedin the posting, quotedConflictsposted two ways, both shownNot mentionedwe looked; it is not there
- Employment typeStated
- Full time
- Work arrangementStated
- On-site
- ExperienceStated
- 2-5 years
- EducationStated
- ['high school', 'bachelor degree', 'professional certificate']
Not mentioned in this posting
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- PayNot mentioned
- The posting does not say
- ShiftNot mentioned
- The posting does not say
- Visa sponsorshipNot mentioned
- The posting does not say
Requirements, each with its sentence from the posting
These are the employer’s words. The index does not judge whether you meet them.
- High School Diploma/GEDrequired
High School Diploma/GED required
from the posting - Clinical research experiencerequired
Two (2) years clinical research related experience required
from the posting - FDA and IRB compliancerequired
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB)
from the posting - Good Clinical Practice (GCP) guidelinesrequired
Maintains research practices using Good Clinical Practice (GCP) guidelines
from the posting - HIPAA regulationsrequired
Maintains strict patient confidentiality according to HIPAA regulations and applicable law
from the posting - Bachelor's degree in Science, Sociology or related fieldpreferred
Bachelor's Degree Science, Sociology or related degree preferred
from the posting - SOCRA or ACRP certificationpreferred
SOCRA or ACRP certification preferred
from the posting - Protocol eligibility screeningimplied
screening of potential patients for protocol eligibility
from the posting - Informed consent processimplied
participating in the informed consent process
from the posting - Case Report Form documentationimplied
documents thoroughly on Case Report Forms (CRFs)
from the posting
Read the full posting as the employer wrote it
Passionate about clinical research that addresses rare and complex conditions affecting pediatric populations? Join our team!
The Clinical Research Coordinator II 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 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 information at regular research staff meetings. May plan and coordinate strategies for increasing patient 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).
Primary Duties & Responsibilities:
- Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
- Schedules 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 perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research 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 patient confidentiality according to HIPAA regulations and applicable law.
- May coordinate training and education of other personnel.
- May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
- May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.
- May identify quality and performance improvement opportunities and collaborate 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.
Qualifications
Education, Experience, Licenses/Certifications:
- High School Diploma/GED required. Bachelor's Degree Science, Sociology or related degree preferred.
- Two (2) years clinical research related experience required.
- SOCRA or ACRP certification preferred.
About the organization
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.The posting text is reproduced as the employer wrote it; the index adds nothing to it.