Research Administration - Saint John’s Cancer Institute

Providence Los Angeles Research Center (PLARC)

We are committed to developing the research interests of our clinicians and to offer valuable and life-changing research options to all of our Providence patients. Our PLARC staff can help you with everything from research study start-up to study execution. We have established relationships with various industry sponsors who are always looking for new physician partners to bring about the latest novel therapies to patient populations.

Please reach out to us with all your questions. We look forward to working with you and developing your research interests.

Mission & Vision

Mission:

PLARC supports and advances the overall Providence Health & Services’ (PH&S) mission by providing regional leadership and expertise in research administration while ensuring compliance with all regulations.

Vision:

PLARC partners with PH&S physicians, scientists, and affiliates in obtaining and negotiating sponsored research funding, supporting their professional growth, and providing stewardship of sponsored/philanthropic funding in an ethical and accountable manner.

Meet Our Team

Scope

The role of PLARC is to facilitate discoveries in translational sciences and to increase and make available novel, targeted and cutting-edge clinical trials that patients can receive close to home. PLARC accomplishes this by providing value-based consultation and management services that focus on favorable outcomes for patients, caregivers, and communities, as well as competitive business metrics.

Providence Health & Services – Southern California and its affiliates are considered to be “engaged” in research, and thus are subject to the requirements of PLARC, if the person conducting or supervising the research is a faculty or staff member, clinical and postdoctoral fellow, or other agent in connection with his or her Providence-related responsibilities. Providence-related responsibilities refers to activities and obligations of faculty, staff, fellows and post-docs in their roles as employees or affiliates.

PLARC Functions

PLARC Assists with the Following Functions:

Delays in research have significant time and cost implications and can negatively impact an organization. The potential for delays can be decreased or mitigated through comprehensive planning. A thorough feasibility assessment can help in identifying challenges before-hand and help in taking a decision on how to work efficiently. The internal feasibility assessment includes assessing site demographics such as: prior experience in clinical trials, availability of study coordinators, pharmacists and nurses, adequate time to conduct and oversee the trial as well as site infrastructure (including specific requirements related to drug storage, processing of biological samples, equipment availability) along with anticipated regulatory and ethical challenges. A documented Feasibility Questionnaire will be required for every new study to be performed within the Providence Health System-Southern California.

The PLARC Intake personnel assesses resources needed and assist study teams in initiating new research studies. It is the policy of Providence Health System-Southern California and its affiliates to evaluate each new clinical trial in order to determine what level of PLARC and institutional support are needed. This assessment is performed in the Research Intake Process, during which PLARC evaluates who will be involved in the trial, where the trial will be performed, study characteristics (i.e. type of trial, investigational product/device procurement), utilization of staff, IRB requirements and budgeting/contracting needs. A documented Research Intake will be performed for all research protocols conducted within the Providence Los Angeles Region.

The PLARC Contracts and Grants team supports investigators from grant proposal development to award closeout; ensuring that our grants are consistent with regulations and standards for research and fiscal responsibility. Contracts and Grants supports PLARC’s investigators with review and development of contracts related to research.

The PLARC Medicare Coverage Analyses (MCA) & Budgets staff are dedicated to the preparation of the required MCA and budgets for qualifying clinical trials. In order to ensure compliance with Centers for Medicare and Medicaid Services (CMS) Clinical Trial Policy (CTP) and policies for Medical Device Coverage (MDC), an MCA must be conducted for any clinical research study that involves billable services (i.e., any clinical service/procedure/item that can generate a billing charge).

PLARC Research Finance staff includes financial analysts dedicated to the financial aspects of the clinical study. The analyst will prepare the monthly invoicing to the sponsors, manage the accounts receivable, process any payments to third parties and work the EPIC queues for charge segregations. Also, they will handle the financial aspects of the close out of a study making sure there are no outstanding payments. This function is critical to recognizing revenue for the research enterprise. PLARC Research Finance manages invoicing and payments for all ministries that have a Clinical Trial Agreement (CTA) with PLARC.

PLARC Regulatory Affairs is responsible for managing all aspects of protocol submissions on all regulated submissions that include Institutional Review Board (IRB) and if applicable Institutional Biosafety Committee (IBC) oversight. Regulatory Affairs manages all aspects of protocol processing and submission to internal and external IRBs and IBCs.