Psychiatry Other job located in Florida

Psychiatry - Miami, FL

JOB TITLE: Principal Investigator/ Sub Investigator

REPORTS TO: Associate Medical Director

DEPT: Medical & Clinical

JOB SUMMARY The Principal Investigator (PI) is responsible for the oversight and execution of Clinical Studies performed on behalf of the Sponsor. The PI promotes Good Clinical Practices (GCP) in the conduct of Clinical Investigations by ensuring the integrity of data generated at the site and directing the conduct of the clinical investigation as to the guidelines issued by State and Federal Authorities and the Sponsor.

DUTIES & ESSENTIAL JOB FUNCTIONS
Provide Qualifications & Agreements:
- Will be responsible for maintaining up-to-date curriculum vitae
- Maintaining all required licenses to practice and execute the job as PI
- Providing Sponsor and IRB with documentation of credentials as required
- Demonstrating the proper education, training and experience to conduct the clinical investigation
- Assuming the responsibility for the conduct of the clinical investigation
- Signing sponsor contract as appropriate
- Disclosing conflicts of interest as described in the regulations

Ensure Protocol Compliance:
- Processing a thorough understanding of the requirements of each protocol
- Determining that inclusion/exclusion criteria are applicable to the study population
- Ensuring recruitment goals are reasonable and attainable
- Assessing the overall protocol feasibility
- Following the trial's randomization procedures
- Not implementing any protocol deviation or changes without agreement by the sponsor and prior review and approval by the IRB (except to eliminate immediate hazards to subject)
- Reviewing the inclusion/exclusion criteria, schedule of visits, end point criteria and investigational article use with the research team

Ensure Initial and Ongoing Review by a Duly Constituted IRB
- Providing the IRB with adequate information to initially review the study (i.e. protocol, investigators brochure, informed consent forms, recruitment advertisements and any written information to be given to subjects)
- Providing the IRB with documents for ongoing review (i.e. amendments to the protocol, adverse events, deviations or new information)
- Securing written IRB approval prior to initiating the study or instituting any changes to the protocol as approved
- Providing written summaries of the trial status to the IRB annually, or as requested
- Providing IRB with all documents subject to their review

Determines Adequate Resources are available to conduct study:
- Having adequate number of qualified staff to conduct the study
- Having adequate facilities to conduct the study
- Ensuring he/she has adequate time to conduct and supervise the study

Manages the Medical Care of subjects:
- Having adequate number of qualified staff to conduct the study
- Having adequate facilities to conduct the study
- Ensuring he/she has adequate time to conduct and supervise the study

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