Southern California Clinical and Translational Science Institute
Translating Science into Solutions for Better Health

Join our Institute as the Clinical Research Support(CRS) Operations Director!

The Clinical Research Support (CRS) is a centralized unit within SC CTSI which supports the conduct of non-cancer, investigator-initiated clinical trials and translational research projects. The goals of CRS services are to help investigators assure that protocols are well designed, enrollment goals are statistically valid and achievable, study workflows are efficient, regulatory requirements are met, and statistical analysis and reporting of results are timely and compliant.

Join our Institute as the Clinical Research Support(CRS) Operations Director!

Summary of Responsibilities:

The CRS Operations Director is responsible for developing, implementing, directing, and managing day-to-day activities and services provided by CRS. This includes but not limited to the study coordinator pool, nursing and outpatient research services provided by the Clinical Trials Unit, and support for budget development, participant recruitment, and regulatory services. This position is responsible for providing investigators and research staff resources, tools and training opportunities to ensure clinical research supported by CRS and SC CTSI is conducted in accordance with federal, state, local and institutional guidelines and regulations. 

Key Responsibilities - Detailed Description/Accountability

50% Operations Support:

  • Responsible for developing, implementing, directing and managing operation of CRS activities. Manages the planning, design, development and implementation of CRS and CTU staffing, SOPs and systems to facilitate the conduct of highly scientific, efficient and effective clinical and translational research projects at USC.
  • Oversees the recruitment and performance management of staff. Identifies and promotes coaching, educational and professional development for new and existing staff. Evaluates, counsels, disciplines and/or terminates employees as required.
  • Works closely with CRS Director in the development and coordination of short and long range goals; ensures goals are consistent with the Southern California Clinical and Translational Science Institute (SC CTSI) strategic mission, goals, plans and priorities.
  • Works closely with USC, Keck Medical Center and other stakeholders in the development, implementation and maintenance of institutional systems, policies and procedures related to clinical research.

25% Training and Quality Assurance Support:

  • Works closely with SC CTSI programs, USC, Keck Medical Center and other stakeholders to develop and implement educational and training opportunities to ensure all clinical research supported by CRS is conducted according to federal, state, local and institutional guidelines and regulations pertaining to the proper conduct of research.
  • Maintains competency with regards to changes in regulations and developments in clinical research, both internally and externally. Ensures information is disseminated to appropriate departments, investigators and/or staff.
  • Develops, reviews and implements quality assurance measures for patient care provided by CRS and CTU staff and associated study teams. Adheres to nursing and patient care policies and standards, and initiate action to correct or enhance care as needed.

15% Evaluation Support:

  • Develops, reviews and reports metrics to assess quality of CRS services provided to investigators and research staff; uses information obtained to implement new or improve existing programs and/or processes.
  • Collects a variety of data, performs analyses and reports results to leadership regarding overall clinical research performance, including but not limited to: study enrollment and start-up metrics, general status updates to Investigators and study teams, usage of CRS to determine growth year to year; potential target areas for development.

10% Other Support:

  • Responsible for marketing and promotion of CRS, ensuring investigators and staff are aware of the full breadth of support services.
  • Performs other related duties as assigned or requested. The University reserves the right to add or changes duties at any time.

Qualifications:

Preferred Education:

  • Licensed RN in California; in-depth knowledge of nursing theory and practice, clinical research expertise.  Master’s degree in healthcare or research related field preferred; Clinical Research Certification (ACRP, SOCRA or equivalent) preferred (or ability to obtain within 6 months). Combined experience/education as substitute for minimum education.

Preferred Experience:

  • 7 years’ experience required; 10 years’ experience preferred in Clinical research operations with fiscal management responsibilities preferred; personnel management experience required.
  • Knowledge, Skills and Abilities:
  • Excellent organizational, planning and analysis skills with demonstrated attention to detail; people management skills with “hands on” management style; excellent customer services/client facing skills; excellent verbal and written communication skills; demonstrated ability to work well independently and as part of a team; self-directed and goal-oriented.  Excellent skills in scheduling, assessment and evaluation, training and counseling, interviewing, and staff development.
  • Current knowledge of local and federal regulations pertaining to the proper conduct of clinical research, including Food and Drug Administration (FDA), Good Clinical Practice (GCP), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), International Conference on Harmonization (ICH).
  • Proficient with MS Office Suite (Word, Excel, Powerpoint).
  • Expertise in Clinical Research: Directly related program management experience. Expert knowledge of field, teaching experience and/or active in research. Ability to manage sponsored projects and fundraise.

Supervises: Clinical and Administrative Staff of various roles.
Supervises – Nature of Work: Clinical Research Staff and Operations
 

To learn more, please contact:

SC CTSI Human Resources

hr@sc-ctsi.org