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Why You Would Be Great at Research Administration

Posted By Allison Streepey, B.A., CRS, PLS, Monday, March 6, 2017

Research administration is the management and oversight of grants and industry-sponsored projects following federal regulations, state laws, and institutional policies and procedures. This includes pre-award and post-award activities, management of the project itself, as well as all areas of compliance and oversight of a funded project.  The framework of these activities is contract law.  A sponsored project could be a contract, grant, or clinical trial and the compliance areas make up the details of what is required within the agreement.  This may include material transfer agreements, use of animals in research, or human subjects research.  

This work is federally mandated and that means oversight of all areas by the institution’s attorneys. Each of the items listed in this article describes a specialized area in which legal professionals would be a perfect fit for the job.  You will see that all areas of research administration fit together like a puzzle and that it is fairly easy to move from one area to the other, especially if you like to read and learn.  

Where are these jobs?  They are typically found at big universities, research facilities, and government agencies.  The skills needed are the exceptional skills of a legal assistant and/or paralegal who understands what it is like to work for an attorney, respects the law, and can concentrate on the details required for this type of work.  

Below is a basic description of the order of events in research administration which includes:  learning how to look for funding for a project, what the funding agency requires, how to read the notice of award (the contract), human resources law with time and effort reporting, how to build a budget, what is required to stay in compliance (conflict of interest reporting and HIPAA requirements, etc.), procurement and cost accounting, and mandatory documentation required to close a project.

Pre-Award

Pre-award starts with looking for funding opportunities in https://www.grants.gov/.  These opportunities serve as a map for what is required for submitting a proposal for a grant.  Preparing proposal submissions brings the opportunity to work with the researcher/scientist/principal investigator by proofreading their writing and following the precise instructions as required by the call for proposals.  (This work is very similar to preparing a brief.)

Pre-award for clinical trials may occur when a drug or other company has been following a researcher’s efforts after a grant-funded research project has been established and a drug or device is being developed or it may come from https://www.grants.gov/.

Post-Award

Post-award begins with the notice of grant award from the funding agency.  This is the contract.  It holds instructions on federal reporting requirements and other information the granting agency may need from the institution, such as proof of conflict of interest management, approval of animal or human subjects in research, data management approval, and in some cases a more detailed budget and justification.  This is also the time that any subcontracts on the funded project will be negotiated and assembled for approval from their institution.  (A subcontract is like a little grant in the big grant.  The same federal regulations apply.)

This is when certain compliance documents must be prepared for the funding agency and are usually managed by separate departments in the institution.  These offices are typically led by attorneys:

  • In an early stage of a drug development, a material transfer agreement may need to be prepared to acquire cells from a federal database.
  • If animals are used in the research, there must be approval from the Institutional Animal Care and Use Committee (IACUC) to ensure ethical and sensitive care and use of animals in research and teaching.  
  • If there are human subjects, there must be proof of HIPAA training from the researcher and all key personnel of each project.  HIPAA is the 1996 Health Insurance Portability and Accountability Act to ensure the privacy and security of health information.  
  • If the funded project has reached the point of using humans in research, approval by the Institutional Review Board (IRB) is mandatory before the project can begin.  The IRB is a federally mandated group of individuals put in place for rigorous review to approve, monitor, and annually review all research projects involving human subjects.  This is one of the most serious offices of an institution because the IRB has the task of ensuring the safety and understanding of the persons who agree to be a part of a research project.
  • Management is required for every research project conflict of interest (COI) to determine if a researcher or key personnel may have potential conflicts and to ensure ethical integrity in research in order to protect the public. 
  • Human resources law for a funded project includes everything about hiring and training and could include the immigration office.  This overlaps with export control and embargoed countries, entities, and persons.
  • For purchasing equipment and other items needed for the project, the Federal Acquisition Regulations (FAR) must be used and state laws must be followed.  The purpose is to use reasonable and appropriate spending, subject to audits, following the White House Office of Budget and Management’s Circulars.  

Closing the Project

  • The scientist will report on the outcomes of the project and, if a drug was discovered or a device was made, the Bayh-Dole Act of 1980 allows the institution to negotiate for the intellectual property.  
  • The funding must be spent in accordance with the agreement and all unspent funds must be returned.

    You can see how the purpose of these offices in supporting funded projects overlap and that a research community at the institution could develop.  There are also professional organizations that support the community of research administrators, such as NCURA, the National Council of University Research Administrators, and SOCRA, the Society of Clinical Research Associates. 

Because research administration is federally mandated, there will always be jobs available and the skills best suited to this kind of work are those of legal support personnel.  For more detailed information about research administration, see the CRA Body of Knowledge from the Research Administrators Certification Council website at http://www.cra-cert.org/bodyofknowledge.html.

 


Allison Streepey, B.A., PLS, CRS holds a Bachelor of Arts degree in Arts and Humanities from the University of Arkansas at Little Rock and graduated with honors.  She is a nationally certified Professional Legal Secretary (PLS) with NALS.  Allison holds UAMS Certifications in Grants Management and as a Research Specialist.  Currently she is the Department Business Administrator for the office of Educational Development.  She is the only person on campus who has experience in pre- and post-award grants management (CON and OED), grants administration for UAMS (ORSP), and served as an Institutional Review Board (IRB) Administrator.  Allison has been a member of NALS for 10 years and has served on the NALS Editorial Board for 5 years.  She is grateful for her NALS Pals everywhere.

 

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