Principal Investigator – Virtual

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee medical aspects and conduct medical evaluations of protocols in alignment with good clinical practice.

• Assess safety reports provided by sponsors.

• Ensure accuracy in case report forms through diligent review and maintenance.

• Safeguard the health and safety of study participants.

• Evaluate subject responses to treatments and address any adverse experiences.

• Carry out physical assessments, examinations, and study procedures as stipulated by study protocols.

• Educate Sub-Investigators and study personnel on protocols and specific procedures.

• Offer medical assistance for protocol clarifications, determinations of inclusion/exclusion, and concerns regarding patient safety or eligibility.

• Review criteria for inclusion/exclusion, endpoint criteria, and the use of investigational products alongside the internal research team.

• Complete necessary Care Access and protocol-specific training.

• Adhere to ICH GCP guidelines and all relevant regulatory mandates.

• Engage in monitoring visits and sponsor meetings.

• Facilitate sponsor monitoring and audits, as well as inspections by relevant regulatory bodies.

⛳️ Requirements

• MD or DO with a valid, unrestricted medical license in the state where the research is conducted.

• Prior experience as a Principal Investigator is mandatory.

• Training and certification in Good Clinical Practice (GCP) are required.

• Exceptional written and verbal communication abilities.

• Capacity to prioritize effectively in a fast-paced setting.

• Keen attention to detail and the ability to uphold confidentiality when managing sensitive information.

• Strong critical thinking and agile problem-solving skills.

• Proficiency in using keyboards and other computer equipment.

• Completion of Care Access and protocol-specific training.

• Compliance with ICH GCP and relevant regulatory standards.

• Care Access is currently unable to sponsor work visas.

🏝️ Benefits

• Paid Time Off (PTO) and Company Paid Holidays.

• 100% Employer-paid options for medical, dental, and vision insurance.

• Health Savings Account and Flexible Spending Accounts available.

• Bi-weekly employer contributions to HSA.

• Company-funded Short-Term and Long-Term Disability insurance.

• 401(k) Retirement Plan with matching contributions from the company.

• Travel requirements are less than 10%, with occasional planned travel.