Primary Investigator

The Principal Investigator (PI) position at Global Alzheimer’s Platform Foundation (GAP) is meant to provide oversight for multiple clinical research trials by assuring adherence to protocol requirements, protecting the rights and welfare of participants, assuring the integrity of data generated at the site and directing the conduct of the clinical investigation according to federal and state regulations and guidance documents. The Principal Investigator is charged with conducting research that generates independent, high quality, and reproducible results.

•     Sign Form FDA 1572/Investigator Statement to acknowledge responsibilities as defined by FDA regulations.

•     Will personally conduct or supervise the described investigation(s).

•     Attests to the absence of financial interests or arrangements as described in the regulations (CFR 54.4) and reported on Form FDA 3454 that is completed by the sponsor, or

•     Provides the sponsor a complete and accurate disclosing of financial interests and arrangements as described in the regulations (CFR 54.4) and reported on Form FDA 3455 that is completed by the sponsor.

•     While retaining knowledge of and overall authority for the conduct of all studies, supervise members of the research team qualified by their education and training to accept these responsibilities for study-related activities not directly performed by the PI.

•     Document the delegation of responsibilities on the Delegation of Responsibility Form.

•     Will inform any potential participants that the drugs are being used for investigational purposes and will ensure that the requirements relating to obtaining informed consent (21 CFR part 50) and institutional review board review and approval (21 CFR part 56) are met.

•     Ensure the safety and welfare of study participants by being knowledgeable about ongoing study protocols and investigational articles.

•     Will review all potential research participant health information to attest to eligibility to participate in a trial, as well as review ongoing medical assessments to report appropriate findings to the sponsor, as well as oversee the well-being and safety of participants. This includes but is not limited to reviewing laboratory reports, imaging reports, reviewing medication lists and medical history information, and conducting physical/neurological examinations, etc.

•     Will report to the sponsor adverse experiences that occur during the investigation(s) in accordance with § 312.64.

•     Participate as appropriate in the interviewing, hiring, and training of individuals recruited as members of the research team.

•     Collaborate with the Site Director on all operational implementations as well as assigning trained research nurse/coordinators to manage each clinical study planned or ongoing at this site.

•     Ensure that specific sponsor requirements of the PI are fulfilled as requested.

•     Meet with sponsors’ representatives as appropriate to discuss planned and ongoing studies.

•     Collaborate with Site Leadership to discuss study performance and fiscal reviews/projections.

•     Meet with auditors/inspectors (internal, sponsor and FDA) at the conclusion of their audits to review findings. Maintain organized files and supplies including essential documents and participant charts.

•     Engages the local community by providing educational talks and teachings related to clinical research, brain health, and specific clinical research trials. Also, takes part in community-based memory screening.

•     Continues to foster relationships with local providers and community partners

•     Provides study specific, industry and disease specific training and updates to the clinical research site as they become available to ensure all are apprised of the ever-changing field and can provide the best care possible under the guidelines of the clinical trial.

Documentation:

•     Maintains and keeps up to date essential documents such as but not limited to:

o  Curriculum Vitae (CV);

o  Medical license;

o  Form FDA 1572, as appropriate;

o  Form FDA 3454 or 3455, as appropriate;

o  Protocol signature page and all subsequent revisions.

o  Investigational Brochure page and all subsequent revisions.

o  Delegation of staff duties according to training, education, and licensing.

•     Maintains and keeps up to date participant documentation related to participation:

o  Reviews all clinical reports such as but not limited to laboratory, imaging, adverse events, and provides written review clinical significance and provides recommendations for addressing any areas of concern.

o  Participant eligibility to enroll in trial.

Active Florida Medical License - non-negotiable

•     Successful track record functioning as a Principal Investigator on at least one (or more) Clinical Trials

•     Ability to demonstrate the proper education, training and experience to conduct clinical investigation

•     Good understanding of ICH-GCP guidelines

•     Detail oriented

•     Ability to work collaboratively and cooperatively with others

•     Applicable certifications and licenses as required by local regulations which are in good standing

The duties above are representative of the nature and level of work assigned and are not necessarily all-inclusive. may want to include are Skills, Education, Experience, or Certifications.]

Example: Excellent verbal and written communication skills