The posting
About Denali:
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.
Key Responsibilities:
Pre-Study Responsibilities:
Protocol & Feasibility Review:
- Review protocol and internal capabilities to support a given protocol.
- Provide feedback to the sponsor regarding the study design and operational aspects.
- Presence is required for introductory meetings with sponsors, site qualification visits, and site initiation visits.
Regulatory Documentation:
- Sign off on required Study Start-Up documentation such as the Investigator's Brochures, FDA Form 1572, and financial disclosure forms.
Study Initiation & Communication:
- Participate in study initiation meetings with the sponsor to understand the study's requirements thoroughly.
Subject Interaction & Screening:
- 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.
During/Post Study Responsibilities:
Study Conduct & Subject Management:
- 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.
Safety Reporting & Documentation:
- 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.
Case Report Forms & On-Site Reviews:
- 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.
Additional Responsibilities Including but not limited to:
Network Development:
- Assistance in business development and maintenance of a network of physician specialists for referrals or study support.
Sponsor Interaction:
- Represent Denali Health's capabilities and experience at sponsor meetings and medical conferences.
Training & SOP Development:
- 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.
Qualifications:
Education:
- MD or DO degree required. A PhD, in a related field may be considered.
- Board certification in a relevant medical specialty is preferred.
- Must uphold GCP certification.
Experience:
- Minimum of 2 years of experience as a Principal Investigator or Sub-Investigator in clinical trials.
- Proficiency in more than 1 language preferred
Skills & Competencies:
- 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.
Key Benefits of the Opportunity:
Flexible Work Arrangements: Conduct research within your own private practice or at our facilities, offering you the flexibility to choose the most convenient location.
Adaptable Scheduling: Commitment typically requires 5-10 hours per week per study. Many study-related activities can be completed in a single day, with options for additional scheduling flexibility.
Why Denali Health?
At Denali Health, we are committed to accelerating therapeutic innovations by breaking the bottlenecks in research and bridging the gap from bench to market. Denali Health promotes an inclusive environment that fosters independence & career growth. Join our team and be part of a dynamic organization that values integrity, innovation, and excellence in clinical research.
Denali Health is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
