Translational Project and Lab Manager - Hybrid - 128658

The Moores Cancer Center (MCC) is one of just 54 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.

Reporting directly to the Associate Director, Clinical Operations of the Clinical Trials Office (CTO), the Translational Research and Lab Project Manager will serve as the UCSD Manager for clinical research collaboration related to clinical databases and clinical specimens. The Translational Research and Lab Project Manager will work closely with oncologists, translational researchers, bioinformaticians, pathologists and geneticists in the context of clinical research protocols whose objective is to further personalized medicine and cancer clinical trials at the UCSD Moores Cancer Center. The incumbent will be actively involved with the MCC biorepository serum/tissue bank of blood and solid tumor samples obtained from Cancer Center patients and serum/tissue bank consented participants.

Provides day-to-day technical leadership and administrative supervision to laboratory staff engaged in the execution of multiple, complex research specimen processing protocols. Provides administrative oversight of research activity and participates in the formulation and implementation of operating strategies and policies, protocols, systems, and procedures. Serve as the investigators' and clinical fellows' primary contact for inquiries related to their clinical trials or lab resources. Additional responsibilities include management and prioritization of queries from Industry, Moores Cancer Center Administration, and from individual PIs. Participates in research grant opportunities and draft grant proposals as required. The Project Manager will interface with clinical monitors to review data accuracy, protocol violations and deviations, and regular updates to reporting, including oversight of medical and clinical research data quality. The incumbent manages all aspects of the CTO lab's operations, including laboratory inventory and maintenance, maintenance of applicable laboratory and equipment certificates, clinical trial implementation and execution, quality assurance and research compliance, and strategic planning and project management.

The Translational Research and Lab Project Manager’s specific duties will include (directly or through subordinates): identifying and obtaining informed consent from patients/participants seen in various cancer center clinics, explain the nature of the study, confidentiality and procedures; screening medical records, abstracting relevant medical data per protocol; coordinating with clinical pathology laboratory for appropriate blood/tissue sample to be drawn/collected; creating and maintaining a database that correlates samples with clinical data; accurately recording patient data into appropriate databases; performing long-term follow up of participating patients and requesting ongoing medical data as applicable. Will act as a liaison with investigators/researchers both at UCSD and in the community; coordinate and oversee start up procedures, project implementation, recruitment, screening, enrollment, and maintenance of patient and subject data; create informational and recruitment materials and act as a liaison with other UCSD departments and community clinics / agencies. Independently create original documents and policies for the Program. Work closely with federal and state regulatory officials. This position requires the candidate to maintain strict confidentiality.

MINIMUM QUALIFICATIONS

• 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 knowledge of clinical research laboratory management practices. Advanced knowledge of human specimen processing policies and practices, ensuing compliance with established protocols and guidelines.

• 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. 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.

• 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.

• 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.

• Demonstrated experience making innovative contributions to clinical trials management and study patient recruitment. Knowledge of clinical trials components including statistics, study methodology, informed consent, eligibility, and adverse events. Demonstrated success and skill at researching, analyzing, and evaluating information for preparation of clinical research protocols.

• Experience in project administration in an academic environment. Knowledge and experience of clinical research management and contract negotiation in an academic institution.

• Demonstrated experience analyzing situations, with ability to recommend and implement effective solutions. Proven Required ability to collect and analyze data, investigate, comprehend, and compile financial, budgetary and program data to interpret policies and procedures and apply them to routine/complex/unique situations.

• Demonstrated leadership skills with experience addressing diverse problems that affect the unit's resources and management. Knowledge of regulatory affairs and personnel management concepts. Demonstrated experience supervising and mentoring staff members. Knowledge and ability to supervise and perform lead duties. Ability to provide training and/or disciplinary action when needed, knowledge of how to provide work direction.

• Strong experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures. Ability to maintain confidentiality.

• 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.

• 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.

• Proven experience managing project budgets including monitoring expenses, creating, and analyzing projections, auditing fiscal reports, and providing status reports. Knowledge of accounting as applied to both University and Medical Center functions. Demonstrated knowledge of medical billing and collections guidelines and procedures.

PREFERRED QUALIFICATIONS

• Advanced degree and/or SoCRA or ACRP Certification.

• Strong knowledge of oncology clinical research trials.

• Strong knowledge of finance, general accounting practices, and business management. Demonstrated ability to manage budgets and adapt objectives to changes in resources. Experience with start-up initiatives.

SPECIAL CONDITIONS

• Employment is subject to a criminal background check and pre-employment physical.

Pay Transparency Act

Annual Full Pay Range: $91,300 - $170,700 (will be prorated if the appointment percentage is less than 100%)

Hourly Equivalent: $43.73 - $81.75

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).