How to Become a Principal Investigator
A Principal Investigator (PI) is the physician who leads the conduct of a clinical trial at a study site. The leadership role of the PI helps create the foundation of a successful clinical trial. The doctor who chooses to be a PI can provide his/her patients the possibility of participating in the study, while assisting drug companies in evaluating the efficacy and safety of these investigational treatments.
The PI is responsible for all clinical research activities at the site. These responsibilities include ensuring the study is run in accordance with national regulatory agency requirements and "Good Clinical Practice" (GCP). GCP is a set of internationally recognized ethical and scientific quality standards for the design, conduct, recording and reporting of clinical trials that involve humans. Compliance with GCP provides assurance that the rights, safety and well-being of trial participants are protected, and that the results of the clinical trials are credible and accurate.
To successfully run a clinical trial, certain ancillary staff are typically needed to support the PI. Most study sites have a study coordinator, a clinically-oriented individual who is involved in the daily operations of a study under the supervision of the PI. This person will often schedule subjects, perform minor assessments and laboratory work (depending on level of clinical skills), and organize the data for transfer into Case Report Forms (CRF). CRFs are the official records that sponsor companies use to house the data collected by the Investigator. It is critical that the information contained in a CRF be accurate, as it is the final information used by statisticians to analyze the safety and efficacy of an investigational drug. As a PI, your responsibilities are two-fold: to assure that your subjects receive appropriate study-related medical care, and to assure that all study-related activities follow the principles of GCP.
Resources Required for Conducting Clinical Trials
Conducting clinical trials requires a number of resources. Here are some of the most commonly used resources:
- Examination rooms for conducting physicals and discussions with study subjects.
- Office equipment such as a computer with high speed internet access, fax machine, and telephone for patient scheduling and study correspondence.
- Phlebotomy and laboratory shipping materials storage area.
- A locked storage area for study materials and study medication.
- A locking calibrated refrigerator and freezer for lab samples (and potentially for study medication).
- Adequate working space for on-site visits from sponsor representatives or regulatory authorities.
- A secure storage area for archiving study records per regulatory requirements.
The PI and ancillary study staff should be available to the sponsor company to review study issues and answer pertinent study related questions.
How to Become Involved in Clinical Trials
There are many avenues by which physicians may enter the clinical research field.
- Contact pharmaceutical or biotechnology companies, and Contract Research Organizations (CROs) directly through their websites or main phone numbers.
- Communicate your services on the internet and/or in industry publications.
- Attend annual meetings for organizations such as the Drug Information Association (DIA) and the Association of Clinical Research Professionals (ACRP).
- Contact a Site Management Organization (SMO). An SMO is a centralized organization sponsoring the activities of several clinical sites under one umbrella. SMOs provide physicians an excellent opportunity to gain research experience.
It is important to be versed in the regulatory requirements involved in the conduct of clinical trials.
Becoming a Principal Investigator for Amgen
Amgen is seeking talented, experienced physicians to potentially become Principal Investigators. We encourage physicians who are interested in clinical research and possibly participating in an Amgen study to look at the therapeutic areas currently in development posted on this site. If you are a specialist in one of these areas, submit your contact information into the Physician Registry Survey. Should a study arise that matches your expertise, you may be contacted by an Amgen representative for further evaluation of your experience and site facilities. A member of the Amgen clinical staff may travel to your site and collect information about you and your staff's clinical research experience, inspect your medical facilities, assess staff experience and availability, and assess overall ability to successfully conduct the clinical investigation effectively. Based upon the results of the meeting, you will be notified if you have been chosen to participate in the study.