Clinical investigators play an important role in the development of drugs, therapies and medical devices to combat disease, treat chronic and degenerative diseases, and improve the health of people throughout the world.

The MCA Clinical Trials Consortium is a resource for all physicians interested in becoming investigators. The consortium’s mission is to facilitate community-wide education, communication and collaboration, as well as to foster collaborative partnerships with integrated research organizations, national site networks and industry associations.

Who Can Conduct Research?

Clinical trials need physicians in private practice to join as investigators. The majority of clinical trial investigators are physicians (MD, DO’s) in private practice. You do not need to be associated with a medical school or teaching hospital to qualify as a clinical investigator. No previous experience as an investigator is needed to qualify.

Benefits of Conducting Research

In addition to helping to advance medical science that can save or improve lives, participating in a trial has the following benefits:

  • Create new revenue streams for medical practices and diagnostic service providers
  • Offer cutting-edge, potentially lifesaving or improving treatment options to patients locally
  • Increase the service offerings of and referrals to a medical practice, and thus increasing competitiveness
  • Improve patient care and potentially health outcomes

Become an Investigator

Before taking on any trials, you will need to take specialized training and establish the infrastructure needed to conduct clinical trials. You can do this either on your own or by finding the right partner who can assist you in this process. 

Below are the different ways to get started on the path to become a clinical trial investigator.

Option 1: Do-It-Yourself (DIY) / Build Your Own Site

Those choosing to set up their own site often do it to retain higher trial margin(s) and profits. Site Management Organizations (SMOs) for example, can charge up to 20% of trial revenue. Additionally, if a physician and wishes to retain control and influence over the business operations of an investigator site and the relationships with industry sponsors, then setting up an independent site may be the option for you.

Option 2: Forming a Collaborative Partnership

Forming a collaborative partnership with a research organization can greatly reduce the inherent risks of starting up a new independent site. The right business partner fitting an organization’s strategic goals and interests can often help providers sustainably run a profitable clinical trial business long-term. Additionally, the right partner can help mitigate the financial and operational risks associated with conducting research on your own including the risks associated with incurring initial start-up costs and on-going fix costs of maintaining operations, even during periods of low patient enrollment or no trial activity.

In fact, given the inherent risks and difficulties associated with setting up and sustaining your own investigative site, it is generally our recommendation that physicians consider partnering with a site network or integrated research organization, before deciding to set up their own clinical trial site.

Learn More

 

Training & Professional Associations

Before taking on any trials, physicians must complete specialized Good Clinical Practice (GCP) training. GCP PI training required by the FDA to get started can be accessed at no cost via the link below:

Good Clinical Practice (GCP) training National Institutes of Health (NIH)

Academic degrees can also be obtained in clinical research and/or medicine development (MS, PhD). Finally, the following professional associations also offer training, resources, and networking avenues to serve the needs of research professionals at multiple stages of their career:

Academy of Physicians in Clinical Research (APCR)
Association of Clinical Research Professionals (ACRP)
Society of Clinical Research Associates (SOCRA)
Regulatory Affairs Professional Society (RAPS)
Collaborative Institutional Training Initiative (CITI) Program
*CITI is free for TTUHSC, BCOMM UTEP,

PI Competency Domains & Guidelines

The following core competency guidelines provide a framework for the knowledge, skills, and attributes necessary to perform the PI role effectively. Clinical trial sites should also familiarize themselves with the new competency domains for clinical research professionals. The clinical research professional competency domains were developed by the Joint Task Force for Clinical Trial Competency in collaboration with ACRP to promote the quality and standardization of the research profession and to ensure clinical research professionals receive the training they need to be successful.

Association of Clinical Research Professionals (ACRP)- PI Competency Guidelines

Certification

The following certifications are available for principal investigators:

Joint Task Force For Clinical Trial Competency Domains -Clinical Research Professional Competency

Association of Clinical Research Professionals (ACRP)- PI Certification

Regional Investigator Registry

Physician (MD, DO), can also consider joining our regional investigator registry.

Below are just a few benefits of joining:

  • Meet, share ideas, network with regional investigators
  • Grow your clinical trial pipeline-we link investigators and sites with CROs, sponsors and other research organizations.
  • Gain access to resources such as a talent pipeline, patient advocacy groups, mentoring opportunities, and more!

If you need assistance in becoming a Principal Investigator, wish to join our Regional Investigator Registry, or receive notifications about upcoming events, learning opportunities, and related clinical trial activities please contact us.

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