Charter Research is a highly experienced and quickly growing clinical research company, based in Winter Park and Lady Lake, FL. We are looking to add to our team to help us fulfill our mission of discovering future medicines for healthier lives. Our company is locally owned and prides itself on providing exceptional patient experience to our participants, as well as offering agile recruitment strategies to our sponsoring agencies. Above all, we are a team, and we are seeking the right team member to add to our foundation.

POSITION OVERVIEW

The Principal Investigator (PI) promotes International Council for Harmonization - Good Clinical Practice (ICH-GCP) in the conduct of clinical investigations by ensuring adherence to protocol requirements, protecting the rights and welfare of study subjects, assuring the integrity of data generated at the site, and directing the conduct of the clinical investigation according to federal and state regulations and guidance documents and the site’s Standard Operating Procedures (SOPs).

Primary Responsibilities

1. Provide investigator qualifications and agreements as required for study participation.

2. Maintain a current, up-to-date curriculum vitae.

3. Maintain current licensure and all related continuing education requirements.

4. Assume responsibility for the conduct of the clinical trial.

5. Maintain documentation of all aspects of the clinical trial.

6. Ensure initial and ongoing review and oversight by a duly constituted IRB.

7. Ensure adequate and properly trained designees are assigned to conduct the clinical trial.

8. Promote and support knowledge and understanding of the protocol within the organization, including within teams not directly responsible for the conduct of the clinical trial.

9. Provide oversight of all designees conducting the clinical trials and ensure compliance with the protocol, ICH-GCP, and the site’s SOPs.

10. Conduct patient procedures and visits, as dictated by the clinical trial protocol.

11. Ensure adequate facilities to conduct the clinical trial.

12. Manage the medical care of study participants.

13. Assist in identifying potentially appropriate subjects for clinical trials.

14. Oversee the enrollment goals of the clinical research trial and make every effort to meet or exceed contractual goals with the sponsor and CRO.

15. Protect the rights and welfare of study subjects.

16. Maintain all subject data in accordance with privacy regulations, as dictated by the clinical trial protocol, ICH-GCP, the site’s SOPs.

17. Ensure the validity of the data reported to Contract Research Organizations (CROs) and sponsors.

18. Ensure documentation of study-related procedures, processes, and events according to the requirements of the protocol, ICH-GCP, and the site’s SOPs.

19. Ensure completion of all study-related documentation according to ALCOA-C standards.

20. Ensure proper use, storage, and return or disposal of all investigational agents.

21. Maintain professional and technical knowledge required for the performance of clinical trials.

22. Develop and maintain exceptional communication with CROs and sponsors of clinical trials.

23. Communicate clinical trial issues to sponsor, CRO, and internal leadership, as appropriate.

24. Prepare for and participate in quality assurance audits conducted by internal teams, study sponsors, federal agencies, or other review groups.

KNOWLEDGE, SKILLS, AND ABILITIES

1. Ability to think critically.

2. Strong medical knowledge supporting proper oversight of subjects participating in clinical trials.

3. Strong organizational, interpersonal, and leadership skills, self-motivation, and high personal integrity and ethics.

4. Ability to determine and prioritize workload.

5. Ability to communicate professionally and courteously, including facilitation, negotiation, and collaboration.

6. Ability to maintain sensitive patient information confidentially.

QUALIFICATIONS

Education

1. Medical Doctorate degree accepted in the U.S.; Board Certified physicians, and those with active DEA licensure preferred.

2. Active medical license to practice medicine in the state of Florida, or an active license that is transferable to Florida within 3 months.

3. Fluency in both Spanish and English preferred.