How to Become a Principal Investigator:

A Principal Investigator (PI) is the physician who leads the conduct of a clinical trial. The leadership role of the PI is the foundation that creates the successful clinical trial. The doctor who chooses to be a PI can offer his/her patients the possibility of receiving unapproved yet promising treatments, while assisting drug companies to evaluate the efficacy and safety of these treatments.

The PI is responsible for all clinical research activities at the center. The FDA mandates the PI to sign a form 1572 that outlines the specific responsibilities a doctor must accept as leader of the clinical investigation. These responsibilities are defined as "Good Clinical Practice" (GCP). GCP is outlined in the Code of Federal Regulations (CFR) in sections 50, 56, 312, and 314. Please refer to the link below for more information regarding GCP.

To successfully run a clinical trial, certain ancillary staff are typically required to support the PI. Most clinical trials employ a "study coordinator", a clinically oriented person involved in the daily operations of a study mandated by a protocol under the supervision of the PI. This person will often schedule patients, perform minor assessments and laboratory work (depends upon level of clinical skills), and organize the data for transfer into Case Report Forms (CRF). CRFs are the official records that drug companies use to house the data collected by the Investigator. It is critical that the information contained in a CRF is accurate, as it is the final information used by statisticians to analyze the safety and efficacy of an investigational medication. As a PI, your responsibilities are twofold: to assure that your patients receive the best medical care, and to assure that all study related activities follow the FDA guidelines of GCP.

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Resources for Conducting Clinical Trials:

Conducting clinical trials requires a number of resources. The more resources a PI can provide, the more likely he/she will be invited to participate in a study. Here are some of the most common resources:

• Examination Rooms for conducting physicals and patient interviews.
• Office equipment such as a computer, 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 study medication).
• Adequate working space for on-site visits from sponsor representatives or regulatory authorities.
• A secure storage area for archiving study records as required by the FDA.

The PI and ancillary study staff should be available to the sponsor company to review study issues and answer pertinent study related questions.

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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 (CRO's) directly at their web sites or main phone numbers.
• Advertise your services on the internet and/or industry publications.
• Attend annual meetings for organizations such as the Drug Information Association (DIA) and the Associates 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. SMO's 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. Classes and seminars are offered by organizations like DIA, ACRP, and Barnett International.

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Becoming a Principal Investigator for Amgen:

Amgen is always seeking talented experienced physicians to become Principal Investigators. We encourage physicians who are interested in clinical research and would like to join forces with Amgen to look at the therapeutic areas currently in development posted on this site. If you are a specialist in one of these areas, you may submit your contact information into the online questionnaire listed on the link "Investigator 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 will travel to your site and collect information about you and your staff's industry 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 in writing if you have been chosen to participate in the study.

Working as a Principal Investigator for Amgen is an exciting endeavor. We look forward to hearing from you soon.

For more information about clinical research, please click here:
FDA Consumer

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