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Associate Director, Clinical Research Operations - Samuel Oschin Comprehensive Cancer Institute

Requisition # 20003141 Apply Now

The Associate Director of the Samuel Oschin Comprehensive Cancer Institute (SOCCI) Cancer Clinical Trials Office (CCTO) is accountable for providing strategic leadership to the clinical, regulatory, and financial units of the SOCCI CCTO. S/he directs managers/supervisors assigned to these units within the CCTO by establishing and implementing operational standards and monitoring progress and compliance. S/he serves as the subject matter expert on best practices on clinical trial management and regulatory requirements.  S/he is accountable for the strategic growth and continued success of the SOCCI CCTO, in collaboration with the Executive Director for SOCCI’s CCTO and CCTO Medical Director. This position reports to the CCTO Executive Director of the SOCCI and works collaboratively to develop, implement, and maintain the infrastructure necessary to support National Cancer Institute (NCI) designation.


In addition the Associate Director will be responsible for the following:


• Responsible for the strategic planning, organizing, and oversight of the SOCCI CCTO including the development of strategies for patient recruitment, compliance, performance and quality improvement, operational efficiency, and employee engagement.
• Incumbent will ensure the development of SOCCI’s clinical research infrastructure that supports the clinical research community and is consistent with expectations of NCI-designated Cancer Centers as outlined in the Cancer Center Support Grant (CCSG) guidelines.
• Ensures that all institutional, local, state, and Federal Regulations, Good Clinical Practice (GCPs), ICH, and IRB requirements are met and that all research programs within SOCCI are structured to continue to meet these expectations.
• The Associate Director oversees a team of highly skilled and efficient clinical research staff charged with upholding the same expectations and requirements including continued focus on increasing efficiencies, improving quality control, and providing a robust training and education program.
• Provides expertise, guidance, and oversight to the operational units within the 
• Incumbent will ensure the development of SOCCI’s clinical research infrastructure that supports the clinical research community and is consistent with expectations of NCI-designated Cancer Centers as outlined in the Cancer Center Support Grant (CCSG) guidelines.
• Ensures that all institutional, local, state, and Federal Regulations, Good Clinical Practice (GCPs), ICH, and IRB requirements are met and that all research programs within SOCCI are structured to continue to meet these expectations.
• The Associate Director oversees a team of highly skilled and efficient clinical research staff charged with upholding the same expectations and requirements including continued focus on increasing efficiencies, improving quality control, and providing a robust training and education program.
• Provides expertise, guidance, and oversight to the operational units within the CCTO (clinical, regulatory, finance, quality, training, information systems, etc.) including but not limited to activities necessary to support:
• Under the guidance of the CCTO Executive Director, support the implementation and/or maintenance of requirements as outlined in the National Cancer Institute’s, Cancer Center Support Grant guidelines relative to all clinical research requirements (i.e. Clinical Protocol and Data Management, Accrual of Women, Minorities, and Children to clinical trials and associated Data Tables);
• Oversee the development, implementation, and updating of SOPs to ensure consistent, safe, and efficient management of clinical trials and continuous improvements in the fiscal integrity of clinical research activities;
• Administrative management of the electronic systems utilized to monitor 
• Administrative management of the electronic systems utilized to monitor CCTO performance and efficiency and participation in the development or the selection of institutional systems that would impact the CCTO operations and conduct of clinical research in the SOCCI;
• Provide oversight for generation of monthly reports including but not limited to 
• Provide oversight for generation of monthly reports including but not limited to CCTO  performance, accrual, monitoring, time to activation, audit visits, and financial performance.
• Ensure accuracy of clinical trial information in all CTMS, clinical trial databases, and tracking systems. Ensure quality, timely, and accurate data and report submission;
• Support the expansion of SOCCI clinical research program across Cedars-Sinai Cancer Network and Affiliate sites in conjunction with institutional leadership;
• Integration of Cedars-Sinai and the SOCCI central research administration initiatives and serve as a pilot for expanding clinical research support services enterprise-wide as appropriate;
• Represent the SOCCI CCTO on Health System committees and task forces. Serve as liaison to advance clinical research interests including participation in community outreach;
• Oversee financial resources, development, and management of clinical trials budgets; and in conjunction with the Executive Director of the 
• Oversee financial resources, development, and management of clinical trials budgets; and in conjunction with the Executive Director of the CCTO and SOCCI Finance Director prepare, monitor, and forecast the CCTO annual operations budget;
• Supervises employees, including responsibility for determining qualifications, hiring, maintaining and improving competence, assigning work, evaluating performance, compensation, discipline and terminating employment.
• Serves as an effective leader by maintaining a positive work climate and promoting an environment that fosters self-directed staff, assists employee to develop and contribute to the organization and applies human resources resource policies fairly and consistently.
• Other duties as assigned.
• Supervises employees, including responsibility for determining qualifications, hiring, maintaining and improving competence, assigning work, evaluating performance, compensation, discipline and terminating employment.
• Serves as an effective leader by maintaining a positive work climate and promoting an environment that fosters self-directed staff, assists employee to develop and contribute to the organization and applies human resources resource policies fairly and consistently.
• Other duties as assigned.

To learn more about the Samuel Oschin Comprehensive Cancer Institute please follow link: https://www.cedars-sinai.org/research/departments-institutes/cancer.html


Educational Requirements:

 

  • Bachelor’s Degree required
  • Master’s degree preferred

 


Qualifications:


  • 8+ years of clinical research experience with 5+ years of managerial level experience, preferably in a large academic medical center or NCI Designated Cancer Center
  • Evidence of progressive leadership experience
  • Knowledge and/or experience with NCI CCSG expectations is preferred
  • Previous experience coordinating and managing oncology clinical research programs preferred
  • SOCRA certification preferred
  • Extensive knowledge in clinical research operations and associated regulations governing clinical research
  • Strong communication skills (verbal and written)
  • Ability to provide leadership and promote collaboration
  • Possess exceptional time management skills
  • Working Title: Associate Director, Clinical Research Operations - Samuel Oschin Comprehensive Cancer Institute
  • Department: SOCCI Clinical Research Office
  • Business Entity: Academic / Research
  • City: Los Angeles
  • Job Category: Academic/Research
  • Job Specialty: Academic/Research Services
  • Position Type: Full-time
  • Shift Length: 8 hour shift
  • Shift Type: Day
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Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at Applicant_Accommodation@cshs.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.

At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu). For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through March each year) as a condition of employment, and annually thereafter as a condition of continued employment.

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