Clinical Operations Director

UCSD   •  

San Diego, CA

Industry: Education

  •  

8 - 10 years

Posted 67 days ago

This job is no longer available.

DESCRIPTION

The Department of Medicine (DOM) is the largest department within the UC San Diego School of Medicine and is responsible for fulfilling the teaching, research, and clinical missions of the UC San Diego School of Medicine. The department employs approximately 470 fulltime faculty, 322 residents, fellows and postdocs and 479 staff personnel. The Division of Infectious Diseases in the Department of Medicine was established in 1968 and since then has grown to include 90+ faculty members. Our research space is co-located within several buildings on and off campus including the Clinical Teaching Facility, the Antiviral Research Center and the Owen Clinic in Hillcrest, and on the La Jolla campus, the Stein Clinical Research Building, the Moores Cancer Center, the Biomedical Research Facility-2, the San Diego VA Medical Center, the Cellular and Molecular Medicine East Building, and the George Palade Laboratories for Cellular and Molecular Medicine. Major international collaborations in Mozambique, Mexico, India, South Africa, Brazil and Peru play important roles in the Division’s international programs.

The Clinical Operations Director manages designing, planning and directing administrative and budget operations for clinical research. Directs subordinate managers in order to achieve broadly stated objectives. Participates in developing long and short term strategies with senior Management. Functions with a high degree of autonomy in executing research.

The Clinical Operations Director acts on behalf of the Principal Investigators on operational matters at the Antiviral Research Center (AVRC) and within the Division of Infectious Diseases and Global Public Health (IDGPH) to ensure compliance according to Federal Regulations with clinical research protocols involving human subjects. This role has significant autonomy to achieve research goals and objectives, ensure that Good Clinical Practices are adhered to and directs and supervises more than 230 active clinical trials and research projects conducted within the AVRC with the assistance of subordinate AVRC managers/supervisors. Independently determines research objectives for numerous protocols and projects based on expectations outlined in the 230+ active protocols, projects, and subprojects running concurrently at the AVRC. Develops novel strategies and policies in order to achieve successful research goals of each individual grant, contract, and project. Major sponsored projects conducted at the AVRC include: The NIH/NIAID AIDS Clinical Trials Group (ACTG) Network; Primary Infection Research Consortium (PIRC); California Collaborative Treatment Group (CCTG), NIH Center for AIDS Research (CFAR) Clinical Core, UCSD Viral Genomics Core, the Center for Innovative Phage Applications and Therapeutics (iPATH), numerous NIH-sponsored investigator-initiated (R01, R21, UO1, UM1, etc) grants, and numerous Pharmaceutical Industry sponsored clinical trials. These duties involve oversight and management of all AVRC staff responsible for conducting various aspects of research programs and also include oversight and direction in conducting performance evaluations, determining and conducting disciplinary actions, directing recommendations for reclassification, developing AVRC specific job descriptions, screening and interviewing job applicants, making salary determinations and hiring and on-boarding selections. Develops strategies for deployment and allocation of resources, research and administrative space, fiscal coordination, management of budgets and resources, and oversight of each of these tasks to ensure goals and objectives of each project are met in a timely manner. Participates in developing short and long-term strategies and goals with Principal Investigators to determine new areas of study, new projects and grant opportunities, and determines the availability of resources, staff, space, logistical support and other resources to define the ability to meet goals, fiscal responsibilities and commitments as required by the University and the Sponsors. Responsible for ongoing assessment of current organizational structure and provides guidance on performance standards and University procedures. Communicates effectively among multiple University Departments and Divisions (Medicine, Pathology, Pediatrics, Laboratory Medicine, Surgery, Emergency Medicine, Infectious Diseases & Global Public Health and Psychiatry) to ensure that scientific, budgetary, personnel, study and space issues are coordinated and addressed. Develops goals in compliance with multiple University, research, VA and commercial laboratories. Provides management strategies, adapts policies and procedures to ensure UCSD AVRC’s current International research partners in Durban and Cape Town, South Africa; Chennai, India, Maputo, Mozambique, and Salvador, Brazil are in compliance with NIH and Federal performance guidelines to protect the quality of our research and integrity of our grant funds. Conducts independent site visits by traveling to these sites annually and as necessary and directing collaborative research projects that are both Investigator-initiated and through NIH networks. Makes determinations for changes in policies, procedures and future directions of the AVRC and its International collaborators from an operational, personnel and fiscal standpoint. With the Medical Director provides oversight to the financial analysts, communicates with various Principal Investigators, NIH project officers, Owen Clinic Physicians

MINIMUM QUALIFICATIONS

  • Master's degree in related area, or equivalent combined experience/ training.

  • Eight (8) or more years of relevant research experience.

  • In depth academic knowledge and applied background in clinical research philosophy. Experience changing methods to fit needs of particular situations. Proven ability to translate clinical research philosophy, clinical and research objectives, policies and procedures into an operational plan.

  • In depth knowledge of clinical research and drug development concepts, federal, state and local laws and regulations, and industry requirements regarding the proper conduct of clinical trials. In depth theoretical and operational knowledge of clinical and patient safety standards and regulations relating to clinical research. -- Knowledge of federally sponsored research procedures and protocols to include NIH and FDA requirements as they relate to regulatory procedures. Expert knowledge of Good Clinical Practice guidelines, HIPAA regulations and Federation Regulations for Internal Review Board submissions.

  • Demonstrable record of successfully running complex clinical research trials.

  • Demonstrated experience in designing and implementing quality control, protocol, and quality assurance and program evaluation systems protocols according to accepted clinical standards.

  • Proven management experience running high performance cross-functional teams to achieve trial, individual and team goals and objectives.

  • Excellent ability to establish collegial and productive relationships with prominent clinical investigators, research partners, industry and key opinion leaders in relevant therapeutic areas in order to develop and apply the strategic intent of the studies.

  • Excellent skills to work collaboratively and act persuasively in sensitive situations; skills in conflict management techniques. Ability to work creatively with others and solicit and incorporate their ideas when appropriate, to be critical about information and apply it appropriately, and to probe, challenge, and to question the status quo.

  • Demonstrated ability to work collaboratively with other cross-functional teams and people with a wide range of educational backgrounds. Demonstrated ability to interface with commercial, regulatory, federal and other members of an extended study team. Ability to influence/ persuade.

  • Leadership abilities to efficiently and effectively chair staff meetings, National meetings and elicit productive communication.

  • Excellent ability to quickly evaluate complex issues and identify multiple options for resolution. Takes initiative and responsibility. Able to solve problems when no precedent exists.

  • Excellent communicator through all mediums and with all groups. Excellent persuasive ability to change the thinking of, or gain acceptance from, others in sensitive situations. Skilled in articulating complex research findings by breaking it down into simple, accurate and understandable pieces.

  • Excels at organizing, simplifying and increasing efficiency of processes and procedures while still maintaining standards and compliance. Proven ability to set goals, implement programs, and evaluate results.

  • Expert user of the campus' clinical information and documentation application programs. Technical proficiency in project management software.

  • Proven ability to formulate solutions, enact new program development, and provide alternatives and implications for implementation.

  • Ability to determine learning/educational needs of staff and a working knowledge of the most relevant resources available to provide training and education.

  • Excellent skill in developing, mentoring and advising supervisory level staff.

SPECIAL CONDITIONS

  • Employment is subject to a criminal background check.

  • International travel

UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, and several outpatient clinics. UC San Diego Medical Center in Hillcrest is a designated Level I Trauma Center and has the only Burn Center in the county. We invite you to join our dynamic team!

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