Principal Investigator

Denali Health•Minneapolis, MN

17h•Hybrid

About The Position

Denali Health is seeking a dedicated and experienced Principal Investigator (PI) to lead and manage clinical research studies within our organization. The PI will be responsible for ensuring the integrity, safety, and success of clinical trials by overseeing all aspects of study design, execution, and compliance. The ideal Principal Investigator will have a strong background in clinical research, a commitment to upholding the highest ethical standards, and a passion for advancing medical science.

Requirements

MD or DO degree required. A PhD, in a related field may be considered.
Must uphold GCP certification.
Minimum of 2 years of experience as a Principal Investigator or Sub-Investigator in clinical trials.
Strong leadership and team management skills.
Excellent communication and interpersonal skills.
In-depth knowledge of GCP, FDA regulations, and IRB processes.
Ability to work collaboratively with multidisciplinary teams.
Detail orientation, and ability to multi-task as needed.

Nice To Haves

Board certification in a relevant medical specialty is preferred.
Proficiency in more than 1 language preferred

Responsibilities

Review protocol and internal capabilities to support a given protocol.
Provide feedback to the sponsor regarding the study design and operational aspects.
Sign off on required Study Start-Up documentation such as the Investigator's Brochures, FDA Form 1572, and financial disclosure forms.
Participate in study initiation meetings with the sponsor to understand the study's requirements thoroughly.
Explain the study details to potential participants, address their questions, and ensure proper informed consent is obtained.
Assist screening examinations to determine subject eligibility.
Review all screening data and approve subjects for enrollment in the study.
Conduct scheduled and unscheduled physical examinations according to the study protocol or in response to adverse events.
Evaluate and manage adverse events, determining their relationship to the investigational product, severity, and cause.
Review pre-dose laboratory work, ECGs, and other study data, taking appropriate action based on these results.
Collaborate with the sponsor to review ongoing safety data.
Submit reports for Serious Adverse Events (SAEs) and other required documentation as per study protocols and regulations.
Review and sign Case Report Forms (CRFs) and finalize Clinical Study Reports.
Report all Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) to the sponsor and IRB within the required timelines.
Conduct an end-of-study data review to determine the need for any re-checks.
Monitor subject safety by performing end-of-study physical exams and following up on any ongoing adverse events.
Review and sign all Case Report Forms (CRFs) at the study's conclusion to ensure accuracy and completeness.
Assist in on-site client reviews of Case Report Forms, providing expert insights and feedback.
Assistance in business development and maintenance of a network of physician specialists for referrals or study support.
Represent Denali Health's capabilities and experience at sponsor meetings and medical conferences.
Assist in developing Standard Operating Procedures (SOPs) and training plans, ensuring adherence to clinical safety procedures.
Facilitate emergency response training and review clinical safety procedures to ensure preparedness and safety at the site.