Associate Principal Investigator (Psychiatry) Opportunity in Miami, Florida!!
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
Manages the Medical Care of subjects:
- Ensuring that a qualified physician (Sub-Investigator) is responsible for all trial related medical decisions
- Assessing the subject compliance with the test article and follow-up visits
- Assessing the subjects response to therapy
- Evaluating for adverse experiences
- Ensuring that medical care is provided to a subject for any adverse event
- Informing subject when medical care is needed to treat an incurrent illness
- Informing the subject's primary physician about their participation in the trial
Protects the Rights and Welfare of subjects:
- Reporting serious adverse events immediately to the sponsor and IRB
- Ensuring that the informed consent form contains all the elements required
- Obtaining a signed and dated informed consent form the subject or subject's legal representative prior to initiating any study related procedures
- Informing the subject or legal representative about all aspects of the clinical trial
- Providing new information about the study or rest article
Ensures Validity of the Data reported to the Sponsor:
- Ensuring the accuracy, completeness, legibility and timeliness of case report forms
- Ensuring that case report forms accurately reflect source documents
- Explaining any discrepancies between source documents and case report forms
- Endorsing changes or corrections to a case report form
Ensures Documentation of Study-Related procedures, processes and events:
- Documenting deviations from the approved protocol
- Documenting and explaining premature unblinding of the investigational product(s)
- Documenting that informed consents has been obtained from the subject or legal representative
- Ascertaining the reason for a patients premature study withdrawal
- Documenting adverse experiences
- Complying with written procedures to document changes to data and/or case report forms
- Maintaining trial documents as required by the regulations and sponsor for the appropriate timeframe and under secure conditions
- Providing study reports as requested by the sponsor, IRB and regulatory authority
Ensure the proper use and storage of Investigational Agents:
- Being thoroughly familiar with the use of the investigational product(s)
- Reading the current investigator's brochure, product insert or other source information
- Assuming responsibility for the investigational product(s) at the trial site
- Ensuring the proper use and storage of the investigational product(s) at the trial site
- Assigning responsibility to the appropriate research pharmacy personnel
- Reviewing the proper use of the study article(s)
Direct Site Operations:
- Communicating effectively with subjects, research team, IRB, sponsor and or CRO
- Meeting regularly with the research team to discuss subject participation and protocol progress
- Ensuring that all research staff is informed about the protocol and investigational agents
- Being knowledgeable about regulatory requirements and GCP standards
- Preparing for and attending investigator and start up meetings
- Participating in monitoring and auditing by the sponsor and appropriate regulatory authorities
- Making available to monitors, auditors, IRB, and regulatory authorities requested trial related records
- Delegating authority at the site appropriately
- Ensuring that all research staff is informed about the trial related duties and functions
- Maintaining a list of qualified persons and their corresponding trial related delegated duties
Maintaining Professional and Technical Knowledge:
- Attending educational workshops
- Reviewing professional publications
- Participating in professional societies
QUALIFICATIONS - Board-certified or board- eligible physician
-Clinical research experience as a principal investigator
-Excellent interpersonal skills
-Excellent written and quantitative skills
Search Jobs