Oncology Research Project Manager - Hybrid/Remote - 119773
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#119773 Oncology Research Project Manager - Hybrid/RemoteExtended Review Date: Mon 11/28/2022
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.
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
This position will remain open until a successful candidate has been identified.
UCSD Layoff from Career Appointment: Apply by 11/02/2022 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 11/14/2022. 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 is one of just 52 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 14 departments (12 clinical, 2 basic sciences), 3 professional schools (School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, School of Public Health), UCSD Health oncology hospitals and clinics; the basic and public health research and outreach of San Diego State University, and the basic and translational research of the La Jolla Institute of Immunology. 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.
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 Oncology Research Project Manager (ORPM) independently oversees and manages research protocols for their assigned disease team in the Clinical Trials Office (CTO). Coordinates and oversees clinical trials from inception through completion, including initiation (site visit coordination) and start-up procedures, protocol implementation, recruitment, screening, enrollment, data management, maintenance of subjects, and finalization of sponsor requirements. Creates informational and recruitment materials and act as a liaison with other UCSD departments and community clinics / agencies for the purpose of implementation of studies.
The ORPM works closely with Principal Investigators to analyze scientific data and propose new related clinical protocols. The incumbent oversees the development of new clinical protocols; provide work direction and direct supervision to clinical operations staff. Works directly with the investigators to develop Disease Teams and manage clinical trial portfolios. Serves as the investigators' and clinical fellows' primary contact for inquiries related to their clinical trials or disease team resources. Manages all aspects of the Disease Team clinical research operations including clinical trial implementation and execution, quality and compliance, and strategic planning and project management.
The ORPM coordinates multiple Disease Team clinical trials at various stages of development, implementation, and close out. Manages the clinical research activities for physicians and supporting research staff working at various UCSD locations, serves as the project director of each protocol, and builds a collaborative research team focused on the efficient performance of clinical trials. Assures compliance with state and federal regulatory guidelines. Oversees the quality of the medical and clinical research data. Interfaces with clinical monitors to review data accuracy, protocol violations and deviations, and regular updates to reporting. Provides direction to the team and guidance to investigators. Provides education and information to the general public concerning the ongoing clinical trials. Independently creates original documents and policies for the team. Works closely with federal and state regulatory officials.
The ORPM prepares, analyzes, and negotiates Disease Team clinical trials budgets in assigned disease areas. Provide fiscal oversight for the Disease Team and associated clinical trial accounts. Administers fiscal, material and human resources within study budget, and manages revenue collection, invoicing, and reimbursement accounting. Recommends changes in staffing and changes to budget to ensure the efficient operation of the function. Reconciles budget spending and salary support and monitor all research related charges to ensure budgetary compliance. Interprets policies and analyze and resolve problems related to budgets, contracts and grants, and resource management.
The ORPM exercises judgement within defined procedures and policies to determine appropriate action. Makes important original contributions and innovative ideas pertaining to the strategies and methodologies used in preparing complex scientific clinical research studies. Seeks and proposes solutions to challenges related to the multidisciplinary trials within the Disease Team. Advises employees regarding resolution of technical problems, and communicates and collaborates with cross-functional teams.
Organizes, analyzes and interprets complex, medical, scientific and/or technical data and contributes substantively in the development of scientific writing of protocols as well as proposals, including participation in Disease Team clinical research, methods, research design, measurement, intervention and analysis. Prepares and approves clinical trial documents such as brochures, training, reports, presentations, safety advisories, and manuals. Additional responsibilities include management and prioritization of queries from Industry, Moores Cancer Center Administration, and from individual PIs. Responsible for protocol development and management of phase I, II, and III clinical trials in patients with advanced illness. Participates in research grant opportunities and draft grant proposals as required.
Supervises staff responsible for working with departments, staff, patients and families in using clinical research techniques. Participates in recruitment and orientation of new employees. Recommends salary actions, promotions, and terminations. Conducts necessary personnel actions for assigned staff including disciplinary actions. May assume full responsibility for the research in delegated studies. Receives assignments in the form of objectives with goals and the processes by which to attain them. Supervises daily operations, and performance requirements. Supervises staff work assignments and schedules to meet clinical research goals and timelines. Works with the Disease Team members to implement structural changes within the Disease Team and reassign projects as needed to maximize time efficiency within the constraints of limited resources. Trains and mentors staff to improve quality and quantity of work. Has full oversight for staffing, performance management, and programmatic workflow of project.
Nine or more years of related experience, education/training, OR a Bachelor’s degree in related area plus five years of related experience/training.
Clinical Trial Professional certification from a professional society within one year in position.
Broad knowledge of clinical or laboratory research and clinical research philosophy. Demonstrated ability to translate clinical research philosophy into business best practices in a trial setting. Knowledge of clinical trials components including statistics, study methodology, informed consent; eligibility; adverse events. Demonstrated success and skill at researching, analyzing and evaluating information for preparation of clinical research protocols.
Demonstrated project management skills. Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities. Strong experience in Clinical Trials and Clinical Trials Program Management. Hands-on experience with Industry sponsored trials, cooperative group trials, and/or investigator initiated trials.
Strong knowledge and experience of the clinical research coordinator and regulatory associate roles. Demonstrated knowledge of regulatory submissions and compliance.
Demonstrated experience managing project budgets including monitoring expenses, creating and analyzing projections, auditing fiscal reports, and providing status reports. Demonstrated ability to successfully create and negotiate clinical trial budgets. Knowledge of accounting as applied to both University and Medical Center functions. Demonstrated knowledge of medical billing and collections guidelines and procedures.
Demonstrated experience managing people with a wide range of educational backgrounds and skills. Demonstrated management and conflict resolution skills to effectively lead and motivate others. Demonstrated experience in training others in the field of research.
Demonstrates good problem-solving and analytical skills. Creatively addresses complex or new problems. Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.
Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. Ability to influence and negotiate.
Excellent interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration.
Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.
Skills to work collaboratively with other cross-functional teams. Ability to interface and collaborate with other members of an extended study team. Ability to influence / persuade. Proven ability to effectively coordinate and integrate programs with others in division, department, and organization.
Working knowledge of clinical or laboratory research, clinical trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting.
Advanced degree and/or SoCRA or ACRP Certification.
Knowledge or experience with oncology research and terminology.
- Employment is subject to a criminal background check and pre-employment physical.
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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