Remote Principal Investigator
Care Access
πRemote - United States
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Job highlights
Summary
Join our team as a Principal Investigator at Care Access, where you'll oversee clinical trials, ensure compliance with regulations, and provide medical support to sub-investigators and study staff. This is a fully remote position with less than 10% travel requirements.
Requirements
- Prior research experience required
- Possess a thorough understanding of the requirements of clinical protocols
- Board Certification in any of the following areas: Internal Medicine, Cardiology, Gastroenterology, Dermatology, Endocrinology, ER, and/or Neurology
- MD/DO License in good standing and willing to be licensed in multiple states
Responsibilities
- Review the inclusion/exclusion criteria, endpoint criteria, and investigational article use with the internal research team
- Determine whether inclusion/exclusion criteria apply to the study population
- Maintain protocol compliance on all clinical trials/studies according to the International Conference on Harmonization-Good Clinical Practice (ICH-GCP), local regulations, and study protocol
- Oversee IRB review of study and ensure written IRB approval is obtained before initiating the study or instituting any changes to the protocol as approved
- Assess subject response to therapy, evaluate and address adverse experiences
- Meet regularly with the research team to discuss subject participation and protocol progress
- Meet with study assigned monitors at regular intervals
- 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
- Maintain essential documents and records necessary for conduction of study
- Train on and implement Care Access Standard Operating Procedures
- Review sponsor provided safety reports
- Review and maintain accurate case report forms
- Sign off electronic case books as required by the study sponsor
- Provide clinical oversight and quality of the studies virtually
- Ensure the medical well-being and safety of the study participants, through the safe performance and execution of the clinical trials/studies
- Participate and engage in driving delivery of study targets, such as: participant recruitment, enrollment and retention
- Perform other duties as assigned
Benefits
- PTO/vacation days, sick days, holidays
- 100% paid medical, dental, and vision Insurance. 75% for dependents
- HSA plan
- Short-term disability, long-term disability, and life Insurance
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