Regulatory Coordinator - Stem Cells - 116725
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#116725 Regulatory Coordinator - Stem CellsExtended Deadline: Tue 7/12/2022
For the safety and well-being of the entire university community, the University of California requires, with few exceptions, that all students, faculty and staff be vaccinated against the COVID-19 virus and influenza before they will be allowed on campus or in a facility or office. For more information visit: Flu Vaccine Mandate / COVID Vaccine Policy
UCSD Layoff from Career Appointment: Apply by 06/02/22 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 06/14/22. Eligible Special Selection clients should contact their Disability Counselor for assistance.
This position will remain open until a successful candidate has been identified.
In 2013, businessman and philanthropist T. Denny Sanford committed $100 million to the creation of the Sanford Stem Cell Clinical Center (Sanford Center) at UC San Diego. This gift established the Sanford Center, a $286 M program to accelerate development of drugs and cell therapies inspired by and derived from current human stem cell research. These advancements establish, promote and disseminate clinical trials and patient therapies that will help more quickly transform promise into reality.
Sanford Stem Cell Clinical Center (Sanford Center) is among the University’s most highly visible and top priority interdisciplinary and multi-institutional programs. Sanford Center provides essential physical and human resources needed to leverage stem cell research currently being conducted at UC San Diego. Due to the complexity of regenerative medicine projects and substantial institutional investment, on a daily basis Sanford Center personnel works with all 9 Vice Chancellor areas: Academic Affairs; Research Affairs; Equality, Diversity, and Inclusion; Student Affairs; Marine Sciences; Health Sciences; Health System; Chief Financial Officer; Advancement; Resource Management and Planning.
As part of UC San Diego Health, Sanford Center motivates University-wide change and sustainability, focusing on creating the structure under which various innovative regenerative medicine units and initiatives are developed. Sanford Center has led several successful and highly visible interdisciplinary faculty recruitments, committing to over $18M towards faculty start-up, retention, and research funds for 17 faculty members. Sanford Center also played a pivotal role in securing over $22M of grants from California Institute of Regenerative Medicine (CIRM), awarded respectively to dept. of Bioengineering, Pediatrics, Cellular & Molecular Medicine, and Sanford Center.
Sanford Center integrates its clinical operations at two UC San Diego medical centers - Jacobs Medical Center (JMC) and the Outpatient Pavilion (OPP) - encompassing 12 inpatient beds and outpatient exam rooms. We have contributed $7M towards the capital construction of JMC and OPP and are committed to another $5.5M towards the completion of these medical centers. Sanford Center is also a significant contributor ($3M) to the expansion and operations of UC San Diego’s GMP facility - Advanced Cell Therapy Laboratory (ACTL), located at 10300 Campus Point Dr, San Diego, CA 92121. The ACTL consists of two ISO 7 clean rooms and a laboratory, occupying 1675 sqft. In addition, through its basic science arm - UCSD Stem Cell Program - Sanford Center provides needed resources and coordination to research conducted at the Sanford Consortium for Regenerative Medicine - an innovative "collaboratory" of San Diego scientists from five major stem cell research institutions: UC San Diego, Sanford Burnham Prebys Medical Discovery Institute, Salk Institute for Biological Studies, Scripps Research Institute, and La Jolla Institute for Allergy & Immunology.
Under general supervision, the Regulatory Coordinator provides regulatory support and project management for product development activities related to the current and pipeline clinical studies of the Sanford Stem Cell Clinical Center's (Sanford Center) clinical research unit. The incumbent interacts with departments/agencies involved in clinical research including HRPP, OCTA, FDA, Research Compliance, and other regulatory agencies pertinent to clinical research with an emphasis on human subject protection, subject consents, and diverse IRB policies applicable for Sanford Center's members. The incumbent works closely with various functional areas and study teams in developing regulatory strategies, facilitating communications with regulatory agencies, and preparing and submitting regulatory documentation.
Strong theoretical knowledge and/or Bachelor's Degree in a social science or basic science such as Biology, Microbiology or a related field and/or an equivalent combination of education and work experience.
Demonstrated experience producing clinical regulatory documents, including proposals, consents, adverse event reports and close out documents.
Knowledge of evolving US regulations, guidelines, and specifications applicable to clinical research. Experience interpreting regulations, guidelines, and precedents related to drugs and biologics development.
Experience in clinical trials research. Strong knowledge of experimental protocols, data gathering, protocol design and evaluation.
Proven experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures.
Strong knowledge of investigational protocols (various trial products, phases and protocol designs).
Experience performing clinical research duties in a clinical research environment such as CRO, academic research institution, and/or a research hospital.
Working knowledge of medical and scientific terminology.
Proven ability to find creative and innovative solutions to adjusting needs of the center. Ability to be resourceful and to understand the overall nature of work/responsibilities to establish useful resources and University contacts.
Proven ability to problem solve and resolve conflict.
Effective interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a variety of personalities at all levels of the organization, exercising tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness. Skill at negotiating with various personalities and developing internal and external network of contacts. Excellent phone etiquette skills.
Computer proficiency, including working knowledge of various software programs (email, word processing, spreadsheet, database applications, Adobe Acrobat, web browsers, VELOS, REDCap, etc.) and internet browser applications. Experience in conducting searches on the internet. Ability and willingness to learn new software as needed.
- Masters Degree in a related field.
- Certification as Clinical Research Coordinator or PMP certification.
- Experience in Phase 1 clinical trials.
- Knowledge of tissue, cellular and gene therapy.
- Direct experience in U.S. regulatory affairs involving the FDA. Knowledge of foreign regulatory requirement is a plus.
- Employment is subject to a criminal background check and pre-employment physical.
- Occasional evenings and weekends may be required.
Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).
If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.
UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team!
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