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Research Strategic Advisor - Remote - 121184

University of California, San Diego

Job Description

UCSD Layoff from Career Appointment: Apply by 01/26/2023 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.

Special Selection Applicants: Apply by 02/07/2023. Eligible Special Selection clients should contact their Disability Counselor for assistance.

Candidates hired into this position may have the ability to work remotely.

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 Research Strategic Advisor provides guidance and advice on research studies of the Division of Pulmonary, Critical Care and Sleep Medicine's Airway Research and Clinical Trials Center (CTCAR), a center that is devoted to the research of pulmonary disorders including cystic fibrosis (CF), COPD, IPF and asthma. This position works closely with research project teams and senior management to develop prioritized project strategies for addressing key scientific questions, facilitates issue resolution, and meets project timelines and goals. The Research Strategic Advisor provides recommendations based on knowledge of rules, regulations, and guidance governing drugs, devices, and biologics in all phases of product development. The position also serves as scientific liaison and interfaces with cross-functional research team members and principal investigators to ensure project-specific regulatory strategies, processes, and timelines are met.

Contribute original innovative ideas to the development of the CTCAR, including recruitment of sponsors for commercially funded drug studies. Advice faculty, postdoctoral fellows, residents, staff and students on difficulties and problems with the execution of clinical trials. Act as a resource for other CTCAR personnel. Act 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. Interpret research protocols, coordinate and supervise subject testing, data collection and design data analysis protocols to ensure compliance and completion for a variety of studies simultaneously.

As a recognized research expert, applies comprehensive knowledge of clinical research protocols and processes to lead the most complex projects of critical impact.

  • Nine years of related experience, education/training, OR an Bachelor’s degree in related area plus five years of related experience/training.

  • Demonstrated self-discipline and independent judgment completing highly complex, broadly defined assignments.

  • Advanced knowledge and ability to apply all relevant Federal, state, and university regulations policies, and federal guidance documents.

  • Advanced knowledge of quantitative and qualitative research design, scientific research concepts and terminology.

  • Strong proficiency in public speaking, and writing.

  • Expert project management skills. Demonstrated adaptability and flexibility to lead multiple complex, high impact projects and teams. Anticipates and effectively handles change. 5+ years of relevant clinical research experience, including at least 1 year in a leadership role involving complex project/program management.

  • Demonstrated knowledge of pulmonary disease, including direct professional experience with patients with cystic fibrosis.

  • Expert knowledge of clinical research practices and philosophy and expert ability to translate clinical research philosophy into business best practices in a trial setting. Expert knowledge of regulatory requirements. Expert and extensive knowledge of applicable and evolving US regulations, guidelines, and specifications and experience interpreting regulations, guidelines, and precedents related to drugs and biologics development. Ability to understand global regulatory environment. Demonstrated experience in creating and implementing strategies that will ultimately produce vital information from a variety of resources for FDA clinical trials submission. Proven experience with technical documentation for acceptance by Regulatory and Federal agencies.

  • Expert critical thinking skills to challenge conventional practices, adapt established methods for improved uses, pursue ongoing system improvement, create novel solutions to problems, and evaluate new concepts as potential solutions to existing problems.

  • Highly developed communication skills; including verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. Expert ability to influence and negotiate. Exceptional writing and oral presentation skills. Ability to communicate and deal effectively and productively with people at all levels of responsibility, including researchers, governmental officials, other stakeholders, and campus leaders. Control of standard English in written and oral forms.

  • Highly skilled interpersonal skills, including but not limited to: problem-solving, teamwork development, mentoring and leadership with other team members. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of organization.

  • Expert ability to perform all commonly applicable functions in word processing and spreadsheet software. Expert knowledge of clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.

  • Expert 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. Expert ability to effectively coordinate and integrate programs with others in division, department, and organization. Strong demonstrated experience to independently research and remedy high-level, multi-institutional issues and problems.

  • Experience generating and analyzing project timelines, resources, and budget information. Strong understanding of financial resource planning systems, processes and ability to coordinate project-level budget/resource estimates and manage actual costs vs. planned costs.

  • Demonstrated ability to organize, interpret, evaluate, and present research findings in a variety of formats including research manuscripts, grant proposals, external manuscripts, and oral presentations and in collaborative and instructional scientific interactions within laboratory and discussion settings.

  • Advanced degree preferred.
  • Employment is subject to a criminal background check.

  • Occasional evenings and weekends may be required.

Pay Transparency Act Full Salary Range: $63,400 - $142,800 Annually

The University of California, San Diego is required to provide a reasonable estimate of the compensation range for this role. This range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. It is not typical for an individual to be offered a salary at or near the top of the range for a position. Salary offers are determined based on final candidate qualifications and experience. The full salary range for this position is defined as the Full Pay Range. The budgeted salary or hourly range that the University reasonably expects to pay for this position defined as the Expected Pay Scale. Placement within the Expected Pay Scale is determined by internal equity, relevant qualifications, and collective bargaining agreements (when applicable).

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!

Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.

To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit UC San Diego Principles of Community .

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

UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.

UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening.

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