Clinical Research Supervisor 1 - 134157

UCSD Neurosciences has one of San Diego's most comprehensive neuromuscular clinical programs providing care to neuromuscular patients with muscular dystrophies and myopathies, hereditary and acquired neuropathies, neuromuscular junction disorders and spinal muscular atrophy (SMA). The Neuromuscular Research Program is a rapidly growing epicenter of research and offers these neuromuscular patients the opportunity to participate in cutting-edge therapeutics through clinical trials. The types of clinical research trials include industry-sponsored clinical trials, federally (NIH, FDA or DoD) funded clinical research trials, and investigator-initiated clinical trials.

Under direction, the incumbent will serve as the Clinical Research Supervisor for the growing Neuromuscular Research Program which conducts niche transformational phase 1 clinical trials involving gene therapies, RNA therapies, and small molecules, more routine phase 2 and 3 studies in the same categories, and observational (natural history or registry) studies including biorepositories. The incumbent will be responsible for coordinating all management and administrative activities of the Neuromuscular Research Program and directing and supervising clinical research and administrative staff under the guidance of the program's Principal Investigator. Responsibilities include supervising, providing work direction, setting priorities for new and continuing staff, conducting performance evaluations, developing and submitting IRB forms, devising work schedules, and participating in all aspects of the hiring process. The incumbent interfaces and prioritizes work and interactions with outside and inside sections including industry, government or foundation funders/sponsors, the clinical care programs at UCSD (MDA Clinics), team of Neurologists, and staff.

Additionally, the incumbent will participate in the clinical trial investigator's meetings and contribute important ideas pertaining to the planning, implementation, and execution of the clinical research trials. The incumbent will manage regulatory, and clinical processes for all the clinical trials of this unit, including phase 1, that are often first-in-man and high profile internationally and must be carried out efficiently and precisely. The incumbent will supervise and coordinate multiple components of the clinical research studies involving various collaborative teams including the Principal Investigator, other faculty co-investigators, data managers, industry sponsors and other support staff. The position requires collaborative nature and mentoring of allied programs within UCSD.

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 a 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.

• 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.

• 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.

• 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.

• Demonstrated knowledge of academic institutional review board clinical trials submission process and regulations.

• Demonstrated experience in interpreting medical charts and extracting accurate data from medical records.

• Knowledge of Human Subjects Protection requirements.

• Demonstrated ability to understand and interpret complex research protocols in order to screen patients for eligibility, initiate study plan, collect data, evaluated for adverse events and protocol deviations.

• Demonstrated experience working with FDA regulations, policies and procedures, and Good Clinical Practice guidelines for the conduct of clinical research.

• Knowledge and ability to navigate the complexities of involving children in clinical trials research.

• Advanced degree

• Specific knowledge of navigating Rady Research in additional to local/central IRB during start up and protocol amendments in clinical trials involving facilities or personnel at Rady.

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

• Must have ready access to reliable transportation and be willing to travel to work (UCSD and Rady Children's Hospital) on weekends and evenings as needed to complete work required to meet important deadlines or for subject safety related matters.