Do you have a passion for helping human kind? The Division of Rheumatology at Cedars-Sinai has established a comprehensive clinical and translational research program. We are involved in a streamlined infrastructure to support prospective cohorts of patients affected by rheumatic diseases (i.e. disease-based centers of excellence revolving around conditions such as scleroderma, systemic lupus erythematosus, rheumatoid arthritis) and participation in cutting-edge clinical trials. We are seeking a Clinical Research Coordinator II (CRC II) to participate in all the clinical and translational research activities of the Scleroderma Center and Division of Rheumatology! To learn more, please visit: https://www.cedars-sinai.org/programs/rheumatology.html The CRC II will work closely with Scleroderma Center investigators to harmonize clinical research and clinical care efforts by streamlining workflows as needed in the context of dynamic clinical setting. Job Duties and Responsibilities: - 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. Coordinates training and education of other personnel.
- 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.
- May identify new research opportunities and present to investigators.
- Participates in required training and education programs.
Department Specific Job Responsibilities: - Attend weekly meetings and other meetings as needed with the director and division members.
- Assist Scleroderma Center investigators with IRB document preparation and protocol development by developing SOPs for all Scleroderma Center research activities, generating and maintaining inventory of materials used for research, assuring compliance with approved study protocols, creating or modifying data collection forms.
- Develop and maintain study databases, responsible for data entry and data quality/integrity, producing on-demand reports, optimizing data collection workflows and tracking data/sample requests and transfers
- Streamline data/bio specimen collection sharing, ensuring integrity and security of incoming and stored samples, arranging the exchange of and transport of specimens with collaborating Investigators and staff, overseeing the incoming data interpreted from samples and ensure that it is utilized correctly for analysis and publications
- Recruit and consent study participants, tracking recruitment efforts for IRB and internal reporting, collecting processing, and storing tissue samples, assisting with research procedures such as phlebotomy and skin biopsies.
- Attend weekly meetings and other meetings as needed with the director and division members
- Assist Scleroderma Center investigators in setting up and conduct clinical trials, developing, implementing, and coordinating research and administrative procedures for the successful management of clinical trials.
- Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials.
- Discuss study protocols with patients and verify the informed consent documentation.
- Meet with patient for each visit and maintain accessibility to discuss any questions/concerns regarding the study.
- Dispense study medication in a professional and accountable manner following protocol requirements.
- Collect, process, and ship blood/urine specimens at scheduled patient visits.
- Schedule all patient research visits and procedures consistent with protocol requirements.
- Complete and maintain case report forms per FDA guidelines, and review them against the patient's medical record for completeness and accuracy.
- Administer questionnaires/diaries per protocol.
- Ensure that non-serious and serious adverse events are properly documented and reported.
- Screen all laboratory results when received and follow protocol procedure regarding abnormal results.
- Ensure all laboratory results are given to appropriate doctors for review of clinical significance, then file results in the patient study binder.
- Ensure the filing and maintenance of all regulatory documents.
- Schedule monitor visits and set up for monitoring visits prior to monitor's arrival.
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