Job Summary:
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: Assess protocol and internal capabilities, provide feedback to the sponsor, and attend key meetings.
- Regulatory Documentation: Sign off on essential study start-up documents.
- Study Initiation & Communication: Participate in study initiation meetings to fully understand study requirements.
- Subject Interaction & Screening: Explain the study to participants, obtain informed consent, assist in screening, and approve subjects for enrollment.
During/Post Study Responsibilities:
- Study Conduct & Subject Management: Perform physical exams, manage adverse events, review study data, and collaborate with sponsors on safety data.
- Safety Reporting & Documentation: Submit reports for Serious Adverse Events (SAEs), review and finalize Case Report Forms (CRFs), and monitor subject safety throughout the study.
- Case Report Forms & On-Site Reviews: Review and sign CRFs, and assist in on-site reviews, providing expert insights.
Additional Responsibilities:
- Network Development: Support business development and maintain a network of physician specialists.
- Sponsor Interaction: Represent Denali Health at sponsor meetings and medical conferences.
- Training & SOP Development: Assist in developing Standard Operating Procedures (SOPs), train staff, and ensure clinical safety preparedness 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.
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.
Compensation:
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.
