Flexible Lead Clinical Trials Principal Investigator

Denali Health; Philadelphia (Philadelphia County); Remote; USD 180,000 - 260,000; Full time

Job summary

Denali Health is seeking a dedicated Principal Investigator to lead and manage clinical research studies, ensuring integrity, safety, and success of trials across protocol design, execution, and compliance.

The PI will oversee study initiation, screening, adverse event management, and regulatory documentation, collaborating with sponsors and multidisciplinary teams while maintaining GCP standards and ethical responsibilities.

Qualifications

• 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.

Responsibilities

• 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.
• 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.
• 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 SAEs and 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.

Skills

Leadership

Communication

GCP knowledge

Collaboration

Attention to detail

Multitasking

Education

MD/DO

PhD considered

Board certification preferred

GCP certification

Job description

Denali Health is seeking a dedicated Principal Investigator to lead and manage clinical research studies, ensuring integrity, safety, and success of trials across protocol design, execution, and compliance.

The PI will oversee study initiation, screening, adverse event management, and regulatory documentation, collaborating with sponsors and multidisciplinary teams while maintaining GCP standards and ethical responsibilities.