Clinical Research Specialist II, Cancer Shared Services
Los Angeles, California
Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. By joining us in an academic role, you’ll be a part of formulating future ideas for discovery and then translating those discoveries into cures for the benefit and health of the Los Angeles community.
- Full-time & Per-Diem
- Level: Mid to Senior
- Travel: Minimal (if any)
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What makes a successful Clinical Research Specialist II, Cancer Shared Services at Cedars-Sinai? Check out the traits we’re looking for and see if you have the right mix.
Discovery is central to Cedars-Sinai’s mission. Our laboratories and clinics generate ideas, therapies, devices, and systems that contribute to biomedical progress around the world. Cedars-Sinai’s investigators push the frontiers of biomedicine with studies in cardiac care, cancer, digestive health, the neurosciences, women’s health, and more. Cedars-Sinai’s robust academic enterprise shapes the experts who will help redefine medicine for the next generation.
ResponsibilitiesRequisition # HRC0893983
Working under direct supervision of Cedars-Sinai Cancer (CSC) Shared Resources Research Program Administrator, the Clinical Research Specialist II provides clinical research expertise by participating in the design and implementation of research projects as needed. Responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities
- Provides clinical research expertise by participating in the design and implementation of research projects as needed by the department or institution.
- Responsible for specific and assigned aspects of research infrastructure development and/or maintenance.
- Coordinates research projects at an institutional or departmental level.
- Coordinate all aspects of development, ensuring that all deadlines/milestones are met working with deadline driven structure and demonstrated experience in maintaining flexibility and adaptability while implementing institutional change.
- Assists with organizing and scheduling research activities to meet research objectives and study protocol compliance. Communicates with study team personnel to ensure study procedures are followed and research is performed as described in protocol. Serves as contact for subjects, study personnel, Institutional Review Board (IRB) and study sponsor.
- Assists in coordinating study participant activities including recruitment, screening, and correspondence. Determines patient eligibility and schedules subject appointments, tests, and procedures. Completes cases report forms and other study related documents. Produces reports and other materials, as directed.
- Ensures consent process is performed and documented in compliance with FDA, GCP, IRB, HIPAA, SOPs, sponsor and institutional regulations and policies.
- Performs clinical data collection and abstraction
- Maintains accurate, complete and timely records, including source documents, consent forms, case report forms, protocol documents, and regulatory documents.
- Assists with submission of timely, accurate, and complete study continuing review, amendments, and reportable events to IRB.
- Responsible for sample preparation and storage, distribution and shipping of sample, and maintenance of study-specific specimen collection kits and supplies per study's protocol.
- Monitors and oversees inventory levels, orders materials and supplies in accordance with established policies and procedures, and conduct quality and assurance on orders upon receipt.
- Responsible for training, overseeing and coordinating the sample alliquots per established standard operating procedures.
- Assists with biological sample coordination, collection, transportation, and storage. Can include but not limited to blood products, tissue, etc.
- Assists pathologist/pathologist assistant with biological sample archive. Tasks include assisting with storage and retrieval of biological samples for research.
- Assists with identifying and consenting patients for Cancer Biobank
- Assists in the preparation of site for monitor visit and external/internal audits. Provides timely response to queries from sponsor and/or auditors
- Leads study implementation by preparing IRB documents such as: 1. New protocol applications; 2. Informed Consent draft; 3. Protocol modification forms; 4. Adverse Event/Serious Adverse Event summary for annual report; and 5. IND Safety Report Summary sheet for annual report.
- Responsible for the preparation, submission, and maintenance of the following study-related regulatory documents: 1. Current and obsolete versions of protocol and consent forms; 2. FDA form 1572 and/or 1571; 3. Protocol violations/deviations; 4. Serious adverse events; 5. Current and obsolete Investigation Drug Brochures; 6. Documentation of IRB submissions and related correspondence, reports, and letters; 7. Current laboratory certifications and normal reference ranges; 8. Research staff CVs and licenses, training materials, and certifications; and 9. Test article accountability forms, signature logs, etc.
- Chart review and data mining from a variety of Cedars-Sinai systems including but not limited to EPIC, DEEP 6, and PowerPath Client.
- Along with principal investigator and study team, works to maintain and improve study training procedures and is responsible for training entry-level employees on clinical and regulatory procedures as outlined on study protocols.
- Coordinate with the PI and internal/external parties regarding the collection and maintenance of regulatory IRB and other documentation and procedures.
We are always looking to grow our teams with talented people, just like you. That’s why, this position is eligible for our Employee Referral Bonus Program. Refer qualified candidates today!
Why work here?
Beyond an outstanding benefit package and competitive salaries, we take pride in hiring the best, most committed employees. Our staff reflects the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a multifaceted, inclusive environment that fuels innovation and the gold standard of care we strive for.
- Bachelor's degree required and experience in clinical research and/or related setting
- 5 years experience in area of research specialty
- Working Title: Clinical Research Specialist II, Cancer Shared Services
- Department: Cancer Inst Shared Services
- Business Entity: Service Lines & Ops
- City: Los Angeles
- 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) and COVID-19. 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 April each year) as a condition of employment, and annually thereafter as a condition of continued employment, subject to medical exemption or religious accommodation. For the same reason, you may also be required to receive other vaccines such as COVID-19 as a condition of employment. Cedars-Sinai reserves the right to make modifications to its required list of vaccines as required by law and/or policy.Apply Now Apply Later
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