The Principal Investigator (M.D.) is responsible for overseeing the entire clinical research process, knowing the research regulations that apply to their study, as well as any additional requirements imposed by the study Sponsor and regulatory authorities. All duties are carried out in accordance with the Site’s SOPs, Good Clinical Practices (GCP), HIPAA, International Conference of Harmonization (ICH) and OSHA guidelines, and all applicable Local, State and Federal regulations.
· Ensure there are adequate resources and appropriately trained staff to conduct the
· Provides oversight over study activities and tasks delegated to others to ensure that the
research is conducted in compliance with all applicable Federal Regulations and Policies and Procedures.
· Ensure IRB approvals are obtained before study initiation.
· PI is responsible for conducting the study in accordance with the relevant, current protocol(s) and will only make changes in a protocol after notifying the Sponsor, except when necessary to protect the safety, rights, or welfare of subjects.
· Personally, conduct or supervise the described investigation(s).
· Ensure that an IRB that complies with the requirements of 21 CFR Part 56 will be responsible for the initial and continuing review and approval of the clinical investigation.
· Inform subjects, or any persons used as controls, that the drugs are being used for
investigational purposes and ensure that the requirements related to obtaining informed consent in 21 CFR Part 50 and Institutional Review Board (IRB) review and approval in 21 CFR Part 56 are met.
· Report to the Sponsor all adverse experiences that occur during the investigation(s) in
accordance with 21 CFR 312.64.
· Read and understand the information in the Investigator’s Brochure, including the
potential risks and side effects of the drug.
· Ensure that all associates, colleagues, and employees assisting in the conduct of the
study are informed about their obligations in meeting the above commitments.
· Responsible for maintaining adequate and accurate records in accordance with 21 CFR
312.62 and make those records available for inspection in accordance with 21 CFR 312.68.
· Responsible to promptly report to the IRB all changes in the research activity and all
unanticipated outcomes involving risks to human subjects or others. Additionally, the PI will not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects.
· PI must comply with all other requirements regarding the obligations of clinical investigators and all other pertinent requirements in 21 CFR Part 312.
· Completes additional tasks as required by a specific protocol.
· This position reports to the CEO.
· Works well in a team environment.
· Understanding of the clinical research process preferred.
· Excellent written and verbal communication skills.
· High attention to detail and organization.
· Strong knowledge of the clinical research process, including Regulatory requirements, Good Clinical Practices (GCP), HIPAA and International Conference of Harmonization (ICH) guidelines.
· Ability to time manage to meet Sponsors’ strict timelines and requests
· Bi-lingual English/Spanish required.
· Ability to work after hours and weekends if needed.
· Knowledge of Microsoft Office 365.
Education and Experience:
· Clear active Medical License (ME) in the State of Florida.
· Principal Investigator Certification, ACRP or SoCRA preferred.
· Current provider card in Basic Life Support (BLS) and Advanced Cardiac Life Support (ACLS).
Job Type: Full-time
- Monday to Friday – 8:00 am – 4:30 pm, unless otherwise indicated.
- Work Remotely: No
- 401(k) & 401(k) matching plan
- Health + Dental Insurance
- Paid time off
- Referral program
- Professional development
- Life Insurance
Job Types: Full-time, Part-time
Pay: $200,000.00 - $250,000.00 per year
Expected hours: 20 – 40 per week
- 401(k) matching
- Health insurance
- Life insurance
- Paid time off
- Relocation assistance
- Retirement plan
- 4 hour shift
- 8 hour shift
- Monday to Friday
Work Location: In person