We are seeking a Clinical Principal Investigator. The Clinical Principal Investigator (PI) is a physician-scientist responsible for the overall preparation, conduct, and management of sponsored projects, ensuring compliance with all regulatory requirements and institutional policies. This role will manage the development and execution of clinical trial protocols, contribute to data analysis, and maintain strong communication and alignment with sponsors.
Essential Responsibilities
- Manage early phase clinical trials by providing overarching medical direction and comprehensive medical reviews of protocols in conformance with the investigational plan and good clinical practice.
- Provide medical and scientific feasibility of all new sponsor inquiries driving growth through strategic partnerships.
- Lead and manage a matrix team of responsible for responsible for the conduct of early phase oncology trials.
- Ensure the safety and well-being of all participants in the study at the trial site are protected.
- Ensure data collected at the study site is credible and accurate.
- Ensure the rights, integrity, and confidentiality of all participants in the trial at the site are protected.
- Develop close personal working relationships with Sponsors and Clinical Research Organizations involved in study conduct.
- Provide expert guidance and support to clinical operations research staff and sponsor client.
- Lead continuous quality improvement efforts for clinical research services, integrating best practices and fostering a culture of research excellence.
- Develop and implement strategies to enhance patient recruitment and retention in clinical trials.
Required Education and Experience:
- M.D. or equivalent.
- Board Certified in Hematology and/or Medical Oncology.
- Clinical trials experience with a strong interest in drug development.
- Ability to critically analyze clinical scientific data and literature.
- Understanding of GCP principles, safety and adverse event reporting, FDA regulations, and biomedical research ethics.
- A passion for providing excellent clinical care and for working in a collaborative / team-oriented environment.
Preferred Education and Experience:
- Previous experience with industry sponsored clinical trials.
- Excellent communication skills, with experience in publishing and presenting at scientific meetings.
- Translational research experience and familiarity with pharmacokinetics and pharmacodynamics.
Potential applicants should directly contact Mary Vidovich (
[email protected]) or Chris H. Takimoto, MD, PhD (
[email protected]) at START Research
