new project lifecycle

Roles and Responsibilities

Clinical Research

Expand the items below for more details on each segment of the project, or click here to see all of the clinical research responsibilities in one list.

Roles and Responsibilities Clinical Research

The Office of Clinical Research, along with clinical coordinators on campus, manage the clinical trials conducted at UTMB. Clinical trials are considered sponsored research, but typically are managed through the Office of Clinical Research. The responsibilities that might typically fall to the Office of Sponsored Programs will route to the Office of Clinical Research, and some will overlap. The office works closely with clinical coordinators who work directly on the trials.
RegulatoryOversight
  • Along with clinical trial coordinator, monitor and strengthen policies and procedures on an ongoing basis.
  • In conjunction with clinical trial coordinator, develop new policies and procedures where needed.
  • Implement revised and newly created policies with clinical trial coordinators
  • Work with clinical trial coordinator to interpret and implement university policies & federal and other sponsor regulations related to research.
  • If instances of non-compliance and fraudulent activities exist they will be reported to the appropriate office or hotline number. Clinical trial coordinators also are responsible for this.
  • Modify the training sessions as needed based on feedback from the evaluation forms.
  • Help identify vulnerabilities in research compliance.

FindFunding_H



  • Assist PI the identification of potential clinical industry funding sources
  • Review clinical industry sponsor funding announcements through the Research Services Research Funding Library, the Internet and other means in order to match investigators with potential sources of support if requested.
  • Disseminate information on clinical industry funding opportunities, including application guidelines and forms.
  • Identify agency contacts at specific funding clinical industry sponsors.
  • Act as liaison with clinical industry granting agencies, facilitating proposal development and promoting interaction with interested faculty.
  • Provide expert guidance on clinical industry funding opportunities.
  • Conduct educational offerings on finding funding with clinical industry, and preparing budgets, utilizing eRA systems, effectively acquiring research dollars.
DevelopProposal_H



  • Store clinical industry sponsor application templates and retrieve as necessary.
  • Review clinical industry sponsor requirements.
  • Assist in clinical industry sponsor guideline interpretation and compliance – advise PI.
  • Provide guidance to departments on proposal preparation for clinical industry sponsors.
  • Apply industry standard F&A rates to clinical trial agreements. These will be reviewed on a case by case basis.
  • Provide support to Principal Investigator in resolution of issues related to proposal development.  This task includes, but is not limited to, serving as a resource to the Principal Investigator, providing expertise, and offering the benefit of professional development training/education in research administration
  • Perform secondary review on Budget Justification based on funding source
  • Confirm all fringe benefits are included at the appropriate rate for the duration of the project.
  • Provide revised budgets updated on the support information etc. to clinical industry sponsors as needed.


SubmitProposal_H



  • Non-OSP intake departments submit to pre-award for Info Ed Logging.
  • Review clinical industry proposal submissions, including budget, budget justification and document formatting according to sponsor requirements.
  • Provide documentation for submissions to a federal clinical industry sponsor, such as sub recipient letter of commitment, budget and statement of work, Reps and Certs, and completion of agency cover page.
  • Confirm/assure that Principal Investigator and department/grant administrator follow sponsor and UTMB policy and guidelines for proposal preparation, review, approval, and submission.
  • Contact investigator and department regarding missing internal paperwork, if appropriate.
  • Ensure grant, contract and clinical trial agreement applications carry the correct F&A rate.  Reductions or waivers must be supported by a sponsor’s policy/statement or approval by the Chief Research Officer for Research Administration.
  • Ensure application has salary requests reflecting current institutional base salaries, as well as any projected increments or raises.
  • Provide institutional approval of proposal components for clinical industry sponsors.
  • Work with the PIs for those proposals that are mailed to the clinical industry sponsors, and also work with PI's in order to process electronic proposal submissions.
  • Assist with implementation of clinical industry sponsor electronic grant processing systems.
  • Review contracts/agreements, Confidential Disclosure Agreements, Sub recipient Agreements, Clinical Trial Agreements etc. in preparation for negotiations.

  • Generate and negotiate contracts with clinical industry sponsors, in accordance with UTMB and University of Texas System policies and procedures.

ProjectAward_H



  • All correspondence to clinical industry sponsors must go through the appropriate office with a letter of approval.
  • Receive notice of Grant Award (NOA).
  • Notify the Principal Investigator and Dept. Staff of all awards, and ask for budget review.
ManageProject_H


  • Serve as an advisor to the Principal investigator on financial/administrative matters.
  • Generate invoices to send to sponsor on a timely basis.
  • Work with the clinical trial coordinator to maintain all documents related to sponsored project activity based on UTMB or sponsor retention policy.
ProjectCloseout_H



  • Along with the clinical trial coordinator, retain grant and contract financial records for nine years after the last activity on the award as per UTMB Policy on records retention.