Principal Investigator
About The Position
We are seeking a highly skilled and experienced Principal Investigator to join our team. As the Principal Investigator, you will be responsible for oversight of all clinical trials according to study protocols, company processes, and GCP. How You'll Make An Impact Provide overall medical oversight and medical review of protocols in conformance with good clinical practice Review sponsor provided safety reports. Review and maintain accurate case report forms. Ensure that the safety and well-being of all participants in the study at the trial site are protected Assess subject response to therapy, evaluate and address adverse experiences Perform physical assessments, examinations and study procedures as required by study protocols Train Sub-Investigators and study staff members on protocol and protocol specific procedures. Provide medical support to sub-investigators and study staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility. Review the inclusion/exclusion criteria, endpoint criteria, and investigational product use with the internal research team. Complete the necessary Care Access and protocol specific training s C omply with ICH GCP (International Conference on Harmonization – Good Clinical Practice) and all applicable regulatory requirements Participate in monitoring visits and sponsor meetings; allow monitoring and auditing by sponsors and inspection by appropriate regulatory agencies
Requirements
- Excellent written and verbal communication skills
- Ability to effectively prioritize tasks in a fast-paced environment
- Attention to detail and ability to maintain confidentiality when handling sensitive information.
- Critical thinking, dynamic problem-solving skills
- M D or DO with an active, unrestricted medical license (medical license must be valid in the state in which the research is conducted)
- Previous experience as a Principal Investigator is required
- 2 years prior experience as a Principal Investigator or Sub-Investigator, preferred
- Training and certification in Good Clinical Practice (GCP)
Responsibilities
- Provide overall medical oversight and medical review of protocols in conformance with good clinical practice
- Review sponsor provided safety reports.
- Review and maintain accurate case report forms.
- Ensure that the safety and well-being of all participants in the study at the trial site are protected
- Assess subject response to therapy, evaluate and address adverse experiences
- Perform physical assessments, examinations and study procedures as required by study protocols
- Train Sub-Investigators and study staff members on protocol and protocol specific procedures.
- Provide medical support to sub-investigators and study staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
- Review the inclusion/exclusion criteria, endpoint criteria, and investigational product use with the internal research team.
- Complete the necessary Care Access and protocol specific training
- Comply with ICH GCP (International Conference on Harmonization – Good Clinical Practice) and all applicable regulatory requirements
- Participate in monitoring visits and sponsor meetings; allow monitoring and auditing by sponsors and inspection by appropriate regulatory agencies
Benefits
- Paid Time Off (PTO) and Company Paid Holidays
- 100% Employer paid medical, dental, and vision insurance plan options
- Health Savings Account and Flexible Spending Accounts
- Bi-weekly HSA employer contribution
- Company paid Short-Term Disability and Long-Term Disability
- 401(k) Retirement Plan, with Company Match
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
Ph.D. or professional degree
