We have been offering medical research to residents of Central Florida since 2000. With six privately-owned clinical trial facilities our mission is to provide consistent, high-quality clinical research in a professional, ethical and timely manner.
We are looking for a Principal Investigator who can contribute immediately to our rapidly growing CNS and Neurology research practice. Our company is driven by providing excellent care to our subjects and best in class research for our sponsors via a dynamic team of physicians, raters, nurses, and administrative personnel. This is 100% outpatient opportunity working Monday thru Friday 9AM to 4pm or 8AM to 5pm.
Seeking a Gastroenterologist Physician that will serve as a Principal or Sub-Investigator for clinical trials with pharmaceutical companies testing new medications. The Principal Investigator is responsible for conducting clinical trials in accordance with the research protocol, Good Clinical Practices (GCPs), and federal/state regulations. The PI will collaborate with our study team, as well as various medical, pharmaceutical company and regulatory personnel to ensure the health and welfare of study participants. Salary is competitive with full benefits, health, 401K, disability, and signing bonus.
1. Maintain current license to practice medicine.
2. Assume responsibility as the Principal or Sub-Investigator for the duration of clinical trials.
3. Strong working knowledge of regulatory requirements and GCP standards.
4. Possess thorough understanding of the clinical research protocol and patient population for which the trial is designed.
5. Perform evaluations.
6. Complete training as required per sponsor’s vendors to obtain certification to conduct testing and rating scales for specific protocols.
7. Conduct testing and rating scales per sponsor’s instructions and protocols. Completion of all documentation, paper and electronic, as required per protocol.
8. Evaluate subjects for clinical research trials based on their past medical and psychiatric history in comparison to the protocol specific inclusion and exclusion criteria.
9. Ensure appropriate delegation and training of the clinical research staff.
10. Educate study staff on patient population and mechanism of action of the study medication.
11. Evaluate subject safety and compliance with the study medication as specified in the clinical research protocol.
12. Provide detailed study related documentation as required by the clinical research trial to ensure data integrity.
13. Adhere to reporting requirements for safety reports, protocol noncompliance and any other protocol required reports.
14. Ensure subject’s informed consent is obtained appropriately throughout the duration of the clinical trial.
15. Adhere to the requirements detailed on the FDA 1572 or Statement of Investigator form.
16. Collaborate with Site Leadership to ensure operations goals are met.
17. Serve as a Key Opinion Leader for psychiatric clinical research trials within the organization and with key customers.
18. Attend Investigator Meetings and educational seminars.
1. Possess a valid M.D. or D.O. degree
2. Board Certification gastroenterology
4. Active DEA license, or able to obtain one
5. Active license to practice medicine in the state of Florida, or ability to obtain one immediately
6. Strong interpersonal and leadership skills, self-motivation, and high personal integrity and ethics required
Education and Experience:
1. Possess a valid MD or DO medical degree
3. 3-5 years experience conducting clinical research trials as either a PI or Sub-investigator, or other relevant experience