Clinical Research Coordinator II - Diabetes Research - Prevention and Control ProgramApply Now Share
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The Clinical Research Coordinator II works independently providing study coordination support for prospective epidemiologic studies and clinical trials. Responsibilities may include screening of participants for eligibility, presenting an overview of study motivation and procedures, administering questionnaires, scheduling and follow-up of research study participants, transporting biospecimens from procedure rooms to the processing laboratory.
Essential Job Duties and Responsibilities:
- Independent study coordination including screening of prospective patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
- Scheduling of patients for research visits and procedures.
- In collaboration with the physician and other medical personnel, documents 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 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.
- Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local IRB.)
- 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.
- Conducts literature reviews and assists in the design of investigator-initiated studies including protocol design and development.
- Works with PI to design and develop study related documents including questionnaires, CRFs, manual of operations, and tracking forms for assigned studies.
- Establishes data collection process for studies and standardize data collection, including data flow, data management, data entry, error identification and correction.
- Work closely with Principal Investigator (PI) to organize research study implementation, enrollment, and tracking of study conduct and progress for studies.
- May be trained on study related machine/equipment and procedures by either study sponsor, PI, or PI designee, if necessary for research study.
- May conduct non-invasive clinical assessments (e.g., vital signs, FibroScan) for research purposes, if applicable, according to Cedars-Sinai policies.
- Trains and communicates with coordinators at other institutions for protocol implementation.
- Local travel to other sites.
- Flexible work hours during weekends.
- Associates degree/college diploma, required.
- BA/BS degree, preferred.
- ACRP/SoCRA (or equivalent) certification preferred.
- Four (4) years minimum of directly related experience, required.
- Five (5) years or more of clinical research experience, preferred.
- Experience in diabetes research, preferred.
- Working Title: Clinical Research Coordinator II - Diabetes Research - Prevention and Control Program
- Department: SOCCI Clinical Research Office
- Business Entity: Academic / Research
- City: West Hollywood
- Job Category: Academic/Research
- Job Specialty: Research Studies/Clinical Trials
- Position Type: Full-time
- Shift Length: 8 hour shift
- Shift Type: Day
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. If you need a reasonable accommodation for any part of the employment process, please contact us by email at Applicant_Accommodation@cshs.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.
At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu). For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through March each year) as a condition of employment, and annually thereafter as a condition of continued employment.Apply NowApply Later