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Program Manager - Quality Monitoring

Requisition # 19003402 Apply Now

In collaboration with the CCTO leadership, the Program Manager will support the growth and development of the Cancer Institute by achieving strategic objectives by overseeing multiple project activities. The Program Manager is responsible for assigned research infrastructure development, oversees projects, communicates status and improvement areas to leaderships and works with leadership team to plan, develop and implement new strategies. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

 

Summary of Essential Job Duties:

  • Responsible for the oversight and provides support for all aspects of a Research Compliance Program within the Cancer Institute, including development and expansion of training related to quality management, participate in monitoring and remediation of issues identified, assist in auditing, data safety and protocol compliance
  • Establish data safety monitoring plan that is in line with NCI expectations and FDA regulations. This includes but is not limited to: data safety monitoring committee (DMC), charter, program for safety monitoring of early phase and low risk clinical trials, data safety monitoring board (DSMB), risk-based monitoring program, investigator-initiated trial monitoring, monitoring for affiliate and/or satellite sites,
  • Establish a robust monitoring plan to ensure compliance and high-quality research at affiliate, satellite and sub-sites (for studies where CSMC serves as the primary site).
  • Develop and implement staffing models, processes, policies and procedures to sustain a high functioning quality management program that supports CPDM, prevention and control, survivorship, lifestyle intervention and other SOCCI human subject research.
  • Responsible not for a single research program nor monitor safety in a single facility but monitor compliance of several research projects or research sites.
  • Coordinates with Legal Department, IRB, Risk management, and other functional areas to enhance policies and systems controls as needed
  • May be responsible for direct supervision, training and providing support to staff including workload assessment and setting performance standards.
  • Provides support and guidance to the clinical teams in the development of appropriate corrective & preventative action plans for external audit CAPs such as NCTN, FDA, EMA, etc.
  • Works closely with training and education lead to identify gaps and provide supplementary education, webinars, training, in-services, policies or procedures to improve clinical research data compliance and overall quality.
  • Actively lead or assist by serving as the Quality Lead in selected program/teams participating in internal quality audits, corrective action plan assessment (CAPA) and other quality reviews (i.e. IRAP, IMV or audits) as a monitor/auditor
  • Serves as the QMC point of contact for all external audit notifications (ie., study teams must notify QMC through this position) and facilitates, coordinates and ensures adequate quality management core staffing for all audit preparations.
  • Demonstrates strong working knowledge of FDA, GCP, IRB and NCI rules, regulations and guidelines. Maintains adequate knowledge of industry trends, GCP regulatory standards and global updates and provides expertise and training sessions to faculty and staff.
  • Proactively identifies strategic and tactical solutions by providing compliance subject matter expertise. Serves as the Quality expert providing guidance, consultation and expertise to the protocol development core, training and education core, faculty, peers and staff.
  • Directs the implementation of appropriate strategic/tactical solutions for compliance. Ensures adoption and identifies any outstanding compliance issues. Identifies non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology while maintaining compliance with applicable study protocols.
  • Facilitates the assessment, investigation and tracking of quality issues, quality performance metrics and regularly reports on the overall quality of the program and productivity of QMC. Helps to compile data for external reports.
  • Leverages E-Systems (i.e. CTMS) to improve efficiencies within the program and ensures systems are in place to ensure timely safety and data reviews as appropriate.
  • Develop staffing models for the QMC, creates and updates policies and processes for standardization across the DRGs regarding data quality. Communicates new policies and changes to the research staff through routine bulletins and/or work instructions


Educational Requirements:

BA/BS, preferred

Master's degree, highly desired

 

License/Certification/Registration Requirements:

ACRP/SoCRA (or equivalent) certification preferred.

 

Experience:

-Five (5) years of Program Management, or related experience, required.


-Ten (10) years of experience in an academic clinical research setting, with 2-5 years’ direct experience in compliance, monitoring or quality management, highly desired.


-Strong compliance background and clear understanding of elements of an effective ethics and compliance program. 


-Experience working in a complex matrix system. 


-Demonstrated ability to be proactive, exercise independent judgment and demonstrated ability to work effectively on cross-functional teams with all levels of management and other company personnel. 


-Strong analytical and problem-solving skills, strong leadership traits, inclination to adopt technology and responsive to urgent compliance issues.


  • Working Title: Program Manager - Quality Monitoring
  • Department: SOCCI Clinical Research Office
  • Business Entity: Academic / Research
  • City: Los Angeles
  • Job Category: Administrative
  • Job Specialty: Administrative
  • 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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