Protocol Development Officer - Hybrid - 126341
#126341 Protocol Development Officer - HybridExtended Review Date: Mon 12/4/2023
UC San Diego values equity, diversity, and inclusion. If you are interested in being part of our team, possess the needed licensure and certifications, and feel that you have most of the qualifications and/or transferable skills for a job opening, we strongly encourage you to apply.
This position will remain open until a successful candidate has been identified.
Current UC San Diego and UC San Diego Health Sciences employees who apply by 11/02/2023 will have priority consideration for this position. Recruiters will refer qualified internal candidates after the first 7 days of the job posting. All qualified external applicants and additional internal applicants who apply after the priority date may have further consideration pending the results of the initial review.
Special Selection Applicants: Apply by 11/09/2023. Eligible Special Selection clients should contact their Disability Counselor for assistance.
This position will work a hybrid schedule which includes a combination of working both onsite at Moores Cancer Center and remote.
The Moores Cancer Center (MCC) is one of just 53 NCI-designated Comprehensive Cancer Centers in the United States and the only one in San Diego County. As a consortium cancer center, it is a collaborative partnership between the UCSD: encompassing 28 departments, 6 schools School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, School of Public Health, Jacobs School of Engineering, School of Biological Sciences & the School of Physical Sciences), UCSD Health oncology hospitals and clinics; the basic and public health research and outreach of San Diego State University (SDSU), and the basic and translational research of the La Jolla Institute of Immunology (LJI). These various programs and units are all dedicated to fulfilling the Moores Cancer Center's mission of reducing cancer's burden. As such, it ranks among the top centers in the nation conducting the continuum of cancer research, providing advanced patient care, and serving the community through outreach and education programs. As a top-ranking, future-oriented organization, we offer challenging career opportunities in a fast-paced and innovative environment. Moores Cancer Center follows a progressive philosophy of career-path development for its employees including opportunities for cross-training, professional development, and progressive responsibility.
MCC's mission is to transform cancer care in our catchment area and beyond by driving exceptional scientific discoveries and innovations in prevention, detection, care, and training. MCC will make a global impact on improving health by reducing cancer burden through accelerated discovery and translation, compassionate and interdisciplinary care, education and community engagement, with the foundation of our core values - Excellence, Innovation and Risk-Taking, Collaboration, Diversity and Service.
The Clinical Trials Office (CTO) at UCSD's Moores Cancer Center administers many clinical trials on behalf of its member investigators, including trials sponsored by National Cancer Institute cooperative groups, pharmaceutical companies, and physician investigators.
The Protocol Development Officer (PDO) is responsible for overseeing and guiding the activation process of Investigator Initiated Trials (IITs) at Moores Cancer Center. In addition to supporting PIs with concept and protocol development, the PDO takes the lead in developing comprehensive study activation and start-up processes, including regulatory submissions, IIT budget development, and trial prioritization.
Nine years of related experience, education/training, OR a Bachelor’s degree in related area plus five years of related experience/training.
Advanced knowledge of clinical research practices and philosophy, and ability to apply knowledge and skills to recommend improvements in methodology. Advanced knowledge of regulatory requirements.
Advanced ability to effectively lead one or more projects with competing to meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.
In depth critical thinking skills to evaluate issues and identify a potential solution. Creatively addresses complex or new problems.
Advanced communication skills; including verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator.
Advanced interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership with other team members. Works well with others to achieve common goals.
Proven ability to perform all commonly applicable functions in word processing and spreadsheet software. Advanced knowledge of clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.
Strong administrative experience using standard word processing and data management software programs, including Word and Excel, to develop and prepare reports. Computer proficiency, including working knowledge of various software programs (such as Adobe Acrobat, web browsers, CTMS, e-Regulatory, Epic, REDCap, etc.) and internet browser applications. Experience in conducting searches on the internet. Ability and willingness to learn new software as needed.
In depth ability to work collaboratively with other cross-functional teams. In depth ability to interface, collaborate and influence / persuade other members of an extended study team.
Advanced experience in Clinical Trials and Clinical Trials Program Management. Hands-on experience with Industry sponsored trials, cooperative group trials, and/or investigator-initiated trials.
Advanced experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures.
Strong background in clinical research to include but not limited to, protocol editing, clinical research coordination, clinical research associate, regulatory coordinator, and/or clinical research project or program management.
Strong understanding of clinical research methods and operations, the Institutional Review Board, FDA IND and IDE submission processes and NIH RAC submission processes.
Experience in project administration in an academic environment. Knowledge and experience of clinical research management and contract negotiation in an academic institution.
Demonstrated experience working in a clinical research environment such as CRO, academic research institution, and/or a research hospital. Experience reading and interpreting clinical trials research protocols.
Strong knowledge of investigational protocols (various trial products, data gathering, phases and protocol designs). Experience working with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines for the conduct of clinical research.
Advanced degree and/or RAC, SoCRA, OR ACRP Certification.
Knowledge or experience with oncology research and terminology.
Demonstrated knowledge of regulatory submissions and compliance.
Proficiency with bibliography management software such as EndNote.
Employment is subject to a criminal background check and pre-employment physical.
Must be willing and able to travel.
Occasional evenings and weekends may be required.
Pay Transparency Act
Annual Full Pay Range: $71,000 - $160,000 (will be prorated if the appointment percentage is less than 100%)
Hourly Equivalent: $34.00 - $76.63
Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable).
If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements.
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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UC San Diego Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity or sexual orientation. For the complete University of California nondiscrimination and affirmative action policy see: http://www-hr.ucsd.edu/saa/nondiscr.html
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