Lead CAR-T Data Reporting Associate
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Job ID: 12834
Job Title: Lead CAR-T Data Reporting Associate
This position supports our exciting CAR-T cell Therapy Program!
About CAR-T Cell Therapy:
City of Hope continues to be at the forefront of a powerful form of immunotherapy known as chimeric antigen receptor (CAR) T cell therapy. Using this approach, immune cells are taken from a patient’s bloodstream, reprogrammed to recognize and attack a specific protein found in cancer cells, then reintroduced into the patient’s system, where they get to work destroying targeted tumor cells. To learn more about this exciting therapy, please visit https://www.cityofhope.org/research/car-t-cell-therapy
The CAR (Chimeric Antigen Receptor) T cell/cellular therapies Lead will direct and manage mandatory data reporting to Center for International Blood and Marrow Transplant Research (CIBMTR), FACT (Foundation for the Accreditation of Cellular Therapy) and product manufacturer. He/she will coordinate and submit data for Allogeneic and Autologous CAR T cell, other cellular therapies and associated transplants if applicable. Manages an assigned set of multiple observational and SOC (Standard of Care) patients required data reporting/projects to assure efficiency and regulatory compliance with Federal /FACT and institutional requirements. Monitors closely data for Cytokine Release Syndrome (CRS), neurotoxicity and other serious adverse reactions to assure timely and accurate reporting. Maintains a system for effective data flow. Has proven to function independently and proficiently as defined in the position accountabilities. Serves as a technical resource for the Department and assists in training of new staff members. Collaborates with REMS leader (Risk Evaluation and Mitigation Strategy), QRRM (Quality Risk and Regulatory Management), HCT Quality Management Council (QMC), HCT Registry and Reporting Committee (HRRC), Immunotherapy disease team and Clinical Cellular Immunotherapy Committee (CCIC) etc. to assure meeting reporting requirements.
Key Responsibilities include:
- Conducts data management and submission of CAR T /cellular therapies data to CIBMTR, FACT, manufacturer etc.
- Maintains current and accurate documentation; notifies City of Hope (COH) Hematology and CAR T leaders of pertinent changes.
- Ensures that patients are appropriately registered in COH and CIBMTR database; maintains documentation of patient registration.
- Compiles and submits data on appropriate forms and different databases according to the CIBMTR/FACT/manufacturer requirements. Assists in data retrieval to be used by Hematology Program, QRRM, FACT reporting, observational studies, etc.
- Ensures regulatory compliance with intense monitoring of specific requirements.
- Participates in the training and quality control monitoring of Clinical Research Associates for transplant data related to the CAR T cells.
- Serves as a technical resource for Department of Hematology, REMS program, CIBMTR reporting, CCIC council and helps to train and mentor new staff members.
- Identifies and participates in additional training/in-service that would benefit all data management staff.
- Collaborates with REMS representative to assure specific timely and accurate serious adverse event reporting for SOC patients as required per the COH contract and FDA (Food and Drug Administration) requirements.
- Participates in database design and development for CAR T cells, other cellular therapies and related transplant data if applicable.
- Coordinates special projects working closely with Hematology physicians, other CRAs, QRRM and Statisticians.
- Makes recommendations and participates in Policy and Procedure development regarding the federal data reporting requirements for CAR T cells.
- Works with supervisor to ensure performance of appropriate levels of quality
- Identifies and communicates important protocol and data management issues or problem areas to supervisor.
- Maintains professional growth and development through seminars, workshops, and professional affiliations to maintain certification/licensure and/or keep abreast of latest trends in field of expertise.
- Is self-motivated in organizing and following through on assigned projects.
- Ensures work environment is organized and functions efficiently
- Attends and participates in meetings as required.
Minimum Education, and Skills Required for Consideration:
- Must have a Bachelor’s Degree (Experience may substitute for minimum requirements)
- Must be certified by either Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA)
- Must have at least 7 years of experience working as a Clinical Research Associate or Coordinator managing Hematology/Transplant projects with extensive experience in transplant data collection and reporting.
- Must have thorough knowledge of hematology transplant research, data collection/management and data processing applications, equipment, techniques, and characteristics.
- This role requires excellent understanding of blood and marrow transplant processes, hematology malignancies, related observational/research studies. This includes understanding the HLA typing, mobilization/apheresis, HCT infusion process, GVHD reporting, toxicity grading, disease response categories, etc.
- Must possess the ability to read, write and comprehend medical terminology
Preferred Education and Skills:
- Bachelor’s Degree
- Relocation assistance may be available
About City of Hope
City of Hope is an independent research and treatment center for cancer, diabetes and other life-threatening diseases. Designated as one of only 49 comprehensive cancer centers, the highest recognition bestowed by the National Cancer Institute, City of Hope is also a founding member of the National Comprehensive Cancer Network, with research and treatment protocols that advance care throughout the world.
City of Hope is located in Duarte, California, just northeast of Los Angeles, with community clinics throughout Southern California. It is ranked as one of "America's Best Hospitals" in cancer by U.S. News & World Report. Founded in 1913, City of Hope is a pioneer in the fields of bone marrow transplantation, diabetes and numerous breakthrough cancer drugs based on technology developed at the institution.
City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.
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