We are seeking a qualified Sub-Investigator (Sub-I) to support the execution of a cardiovascular clinical research study. The ideal candidate will be a licensed MD or DO with prior experience serving as a Sub-Investigator in clinical trials. This role involves working collaboratively with the Principal Investigator (PI) and clinical research team to ensure the study is conducted with the highest standards of quality, safety, and compliance.
Key Responsibilities:
- Collaborate with the Principal Investigator to ensure the successful implementation and conduct of the cardiovascular study protocol.
- Conduct study-related medical evaluations, including physical exams, patient interviews, and safety assessments.
- Confirm participant eligibility and obtain informed consent, as delegated by the PI.
- Identify and report adverse events in compliance with regulatory requirements and study protocols.
- Ensure accurate documentation of study procedures and data entry into case report forms (CRFs) and electronic systems.
- Maintain compliance with FDA regulations, ICH-GCP guidelines, and institutional policies.
- Attend investigator meetings, monitoring visits, and internal study team meetings.
- Contribute to patient recruitment and retention strategies.
- Review and sign off on clinical documentation, including source data and laboratory results, as delegated.
Required Qualifications:
- Medical Doctor (MD) or Doctor of Osteopathic Medicine (DO) degree.
- Active and unrestricted medical license in the state of Florida.
- Previous experience as a Sub-Investigator in clinical research (cardiovascular study experience preferred).
- Strong understanding of clinical research processes, GCP, and regulatory compliance.
- Excellent attention to detail and organizational skills.
- Strong interpersonal and communication skills, with the ability to work in a team-oriented environment.
Preferred Qualifications:
- Experience in cardiovascular clinical trials (eg, heart failure, hypertension, or interventional cardiology).
- Familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Board certification in Internal Medicine or Cardiology.