Associate Principal Investigator (Psychiatry) Opportunity in Miami, Florida!!Doctor’s Choice Placement Services • South/Southeast, Florida, US

Associate Principal Investigator (Psychiatry) Opportunity in Miami, Florida!!

Doctor’s Choice Placement Services • South / Southeast, Florida, US

30+ days ago

Job type

Permanent

Job description

Description

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

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Principal Investigator • South/Southeast, Florida, US

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