Being a Principal Investigator (PI) gives you the opportunity to develop a scientiﬁc vision and lead a team to transform that vision into knowledge. This means that you will be coordinating people to achieve scientiﬁc results, that you will be responsible for obtaining the required resources, using them efﬁciently, and grow personally and scientiﬁcally at an unprecedented pace. You will have the unique chance to provide people opportunities, to foster them to become producers of knowledge and to watch them grow and transform into scientists. Sometimes, if you are lucky, the people with whom you work will be better than you and you will learn an enormous amount from them, and perhaps even more than what you can teach them. Leading a group is therefore not so much about having more hands to work on problems you have deﬁned, but about fostering a mini ecosystem of minds, which will expand the horizons of your science beyond what you would be able to achieve on your own.
Using International Conference on Harmonization Good Clinical Practice as the gold standard for the conduct of human research studies, this rigorous training for new and experienced clinical researchers who are interested in a NanoDegree Program, will focus on providing information on:
- responsibilities of an investigator and/or investigator-sponsor,
- adhering to the protocol and safety plan,
- best practices in consent and screening processes,
- why and how to best document your study,
- monitoring, evaluation and reporting of adverse events and unanticipated problems, and
- IRB application and submission processes..
Leading a research group offers a totally different perspective on science and requires a new skill-set for which few of us have been trained. In addition to continuing to do exciting and innovative science, you will now be expected to be a manager. It is normal to feel anxious about the prospect of leading a laboratory and worrying about all the responsibilities it entails. It is therefore important that you think carefully about whether this is a goal you want to pursue. But if you feel that science is your passion, and you have the drive to see projects through, with added patience to educate new generations of scientists, then this is the career for you. It is a career path that is immensely gratifying, complicated but incredibly dynamic, ever-changing, and that allows freedom of thought and working hours, which few other careers can match.
The Principal Investigator (PI) is the person delegated responsible for the leadership and conduct of a research study at their site. They must ensure that the study is conducted in accordance with the protocol, sponsor instructions, GCP and the relevant legislation; ensuring the dignity, rights, safety and well-being of subjects are given priority at all times. The responsibilities of the Principal Investigator will be clearly delegated in signed agreements between the host site and the sponsor prior to host site approval.
The Principal Investigator can delegate responsibilities to other members of the study team (as appropriate) but must be involved in the active management of the study and should be able to demonstrate complete oversight at their site. It is not acceptable for a Principal Investigator to be a PI in name only, evidence of PI oversight should be demonstrable from audit/inspection of the Investigator Site File (ISF). Examples of evidenced PI oversight would be: up to date signed authorised delegation logs; sign off on the assessment of participant eligibility, sign off on SAEs, sign off on the review of new safety information, regular minuted team meetings and/or 1:1 training/supervision (stating who was in attendance), emails correspondence etc).
Our comprehensive 16-hour Principal Investigator (PI) training will equip you, your practice and/or your hospital, with the fundamental skills and knowledge required of lead investigators in a clinical trial. This NanoDegree Program offers an advanced overview of the variations between Clinical Research and standard care and guidance on how to best navigate your site’s entry into the Clinical Research industry.
Sponsored trials earn anywhere from $50,000 to hundreds of thousands of dollars. Adding trials to your practice or increasing the number of running trials opens the door to new opportunities and additional revenue. Play a key role in creating new treatments that will ultimately advance medicine and save lives.
- The Principal Investigator is responsible for the programmatic management of the grant or contract and conducts the project activities to meet project goals and objectives while adhering to sponsor guidelines and procedures.
- The Principal Investigator is responsible for the financial management of the grant or contract and signs budget expenditure requests or sponsor forms which request the “Principal Investigator” signature.
- Design data collection instruments and methodology; validate instruments; supervision of data collection; analyze data; reporting and publication.
- The Principal Investigator ensures all project expenditures are directly related to the project and necessary to meet the project goals and objectives.
- The Principal Investigator has the responsibility to be aware of any requirements for cost sharing that were committed in the budget approved by the sponsor.
- The Principal Investigator has the responsibility to be aware of requirements to certify the effort of personnel on the grant or contract.
- The Principal Investigator should have no financial conflict of interest which would affect the conduct of the project.
- The Principal Investigator has the responsibility to ensure that Sponsor Compliance policies.
- The Principal Investigator has the responsibility to submit all reports required by the grant or contract on a timely basis.
Contribute to the future of medicine: Today’s Clinical Research leads to tomorrow’s treatments and cures! Adding Clinical Research to your practice allows you to influence medical innovation, improve healthcare, and become a leader in scientific development.
Advance your site: Improve your site’s credibility and professional reputation by hosting the most qualified principal investigators in the field. Clinical Research experience adds value and relevance to your site’s best practices, opening further doors for professional advancement.
Gain access to cutting edge treatments: As a research site, your patients will have access to cutting edge treatments that cannot be prescribed outside of participation in clinical trials, providing the previously unavailable opportunities for rehabilitation and healing.
Increase revenue to your practice: Adding Clinical Research to your practice can introduce a significant new revenue stream without the additional hassle of insurance. Clinical trials sponsored by pharmaceutical companies typically pay anywhere from $50,000 to hundreds of thousands of dollars for each trial. Practices that participate in research often have 5-10 trials running simultaneously, bringing in nearly a million dollars of additional revenue each year.
Acquire new skills: Help your team of principal investigators expand their skills and grow professionally by enabling them to engage with the latest treatments and best practices. This not only helps your team stay up to date with new strategies but also generates additional credibility for your site.
Be a leader: Help shape the future of the medical community through your contributions in the field of clinical research.
A leader in the field of Clinical Research education, BBMI pairs innovative training practices with a network of experienced researchers to offer sites and individuals a comprehensive course in Clinical Research best practices, skills, connections, and knowledge. BBMI is an organization that strongly values personal human interaction and tradition while we nimbly embrace modern disruptive technologies to improve the way we perform research. Our team opens up research opportunities to new communities and contributes meaningfully to current research sites, empowering them to thrive. Our combined and diverse knowledge in conjunction with our extensive connections in the industry allows us to bring proven experience and innovative best practices to our trainees and clients.