Current UC San Diego Health employees who apply by 11/30/2024 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.

The Department of Medicine (DOM) is the largest department within the UCSD School of Medicine and is responsible for fulfilling the teaching, research, and clinical missions of the University of California, San Diego School of Medicine. The department employs approximately 500 salaried faculty, 168 academic appointees, 331 residents, fellow and postdocs and 479 staff personnel.

The Project Manager supervises the clinical research team under the direction of principal investigators at the UC San Diego IBD Center, as well as other studies focusing primarily on IBD and other digestive diseases. Supervises study staff, conduct performance evaluations, and hiring in coordination with the Gastroenterology Division Office. Contributes original innovative ideas to the development of the UC San Diego IBD Center and related clinical trials, including both investigator-initiated clinical trials and industry sponsored trials, as well as prospective cohort studies. Advice faculty, postdoctoral fellows, residents, Staff Research Associate's, and students on difficulties and problems with the execution of clinical trials. Acts as a resource for other IBD Center and IBD Biobank personnel. Acts as a resource for the research studies' regulatory activities including, but not limited to, interpreting, preparation, coordination, implementation, and compliance with the Institutional Review Board (IRB) guidelines, FDA requirements, and Good Clinical Practice procedures. Interprets research protocols, coordinates and supervises subject testing, data collection, and design data analysis protocols to ensure compliance and completion for a variety of studies simultaneously. Supervises and trains personnel in the operation of clinical and research instruments, ensuring quality and efficient assessment of visual function.

Oversees and supervise start-up procedures, implementation, recruitment, screening, enrollment, and maintenance of subjects. Oversees and participates in the creation of informational and recruitment materials and act as a liaison with other UCSD departments and agencies for the purpose of implementation of studies. Oversees the creation of original documents and policies. Works closely with federal and state regulatory officials.

Supervises staff involved in routine research study coordination. Receives predetermined work assignments that are subject to a moderate level of control and review. Oversees staff in execution of assignments; trains and mentors staff to improve quality and quantity of work.

• Seven years of related experience, education/training, OR an Bachelor's degree in related area plus three years of related experience/training.

• Working knowledge of clinical or laboratory research, clinical trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting. Demonstrated experience in clinical trials research. Strong knowledge of experimental protocols, data gathering, protocol design and evaluation.

• 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. Excellent ability to organize/prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities. Meticulous attention to detail.

• Demonstrated skills in employee supervision and HR administration. Demonstrated experience in training others, particularly in the field of research.

• Critical thinking skills to evaluate issues and identify a potential solution.

• Clear and concise communicator; good verbal and written communication skills; both.

• Good 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. Skill at negotiating with various personalities and developing internal and external network of contacts. Excellent phone etiquette skills.

• 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.

• Strong demonstrated experience in leading planning meetings, decision-making and contributing important original ideas pertaining to the development of research funding proposals and research grants.

• Demonstrated experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures. Strong experience in clinical trials research including budget negotiations and invoicing per clinical trial agreement.

• Strong theoretical knowledge in a social science or basic science such as Biology, Microbiology or a related field.

• Demonstrated experience performing clinical research duties in a clinical research environment such as CRO, academic research institution, and/or a research hospital.

• Strong knowledge of investigational protocols especially with pediatric oncology protocols (data management, query resolution, protocol design, protocol writing and protocol implementation).

• Demonstrated experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.

• 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.

• Ability to discern items that can be handled independently and those which require attention of supervisor, including ability to quickly determine subject matter of material and necessary action to be taken in a timely manner.

• Working knowledge of medical and scientific terminology. Demonstrated knowledge of Gastroenterology medical terminology.

• Demonstrated knowledge of Irritable Bowel Disease research and implications.

• Possess a Clinical Research Coordinator Certificate, or Master's Degree.

• Familiarity with Velos.

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