Headquartered in Houston Texas, Omera Health is rapidly expanding its expertise in the clinical research fields of CNS, Respiratory, Cardiovascular, Gastroenterology.
Omera Health expert team has extensive experience in conducting clinical research in accordance with the standards of our Sponsors and CROs.
Responsibilities of the PI, include but not limited to:
- Provide updated CV and Medical License
- Submitting regulatory documents to IRB and Sponsor
- Submitting the clinical study agreement to OSP for review
- Review Protocol/Protocol synopsis
- Attending investigator meeting(s)
- Meet with Sponsor Reps/CRA during PSSV, SIV, IMV, COV
- Preparing for study initiation
- Obtaining physician signatures
- Recruiting subjects
- Screening and scheduling subjects
- Getting voluntary subject consent
- Teaching subjects about protocol expectations for them
- Performing study/protocol procedures in a detailed, accurate format
- Maintaining study files
- Tracking subjects, avoiding lost-to-follow-up
- Complete GCP training
- Complete systems trainings for studies
- PI oversight of patients enrolled (Review Labs and assess for CS, Review AEs, Report SAEs or Pregnancy within 24 hours, Conduct PE)